Text proposed by the Commission

Amendment

(2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality.

(2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, with respect to animals, nature and their interaction with man.

Text proposed by the Commission

Amendment

(6) Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.

(6) Despite the measures that farmers take on good hygiene, feed, management and biosecurity, animals may suffer from a broad range of diseases which need to be prevented or treated by veterinary medicinal products for both animal health and welfare reasons. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. To that end, good husbandry and management practices should be put place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.

Text proposed by the Commission

Amendment

(7) This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

(7) This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and the environment. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

Text proposed by the Commission

Amendment

(7a) This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied. This Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor have any unacceptable effects on the environment.

Text proposed by the Commission

Amendment

(14) Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.

(14) Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment. The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate other administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.

Text proposed by the Commission

Amendment

(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.

(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In such cases, antimicrobial medicinal products for human use could be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain, and particular care should therefore be taken when administering antibiotics to food-producing animals.

Text proposed by the Commission

Amendment

(18) Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.

(18) Member States should be able to allow temporary exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases or new diseases and where the health situation in a Member State so requires.

Text proposed by the Commission

Amendment

(20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely to cause pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

(20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be designed to avoid causing pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.

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15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Text proposed by the Commission

Amendment

(23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.

(23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in exceptional cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. Such products should only be used on the basis of a prescription.

Text proposed by the Commission

Amendment

(25) Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

(25) Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, in particular on veterinary medicinal products for minor species and antimicrobials, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.

Text proposed by the Commission

Amendment

(25a) The research on antimicrobials should be incentivised, not only through the commercial protection of innovative active substances, but also through the protection of significant investments in data generated to improve or maintain on the market an existing antimicrobial product. In such cases, only the new data package would benefit from the period of protection and not the active substance or any associated products.

Text proposed by the Commission

Amendment

(27) It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.

(27) It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. That can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to the European Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible.

Text proposed by the Commission

Amendment

(27a) In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should therefore be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.

Text proposed by the Commission

Amendment

(31) It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

(31) It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should also be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.

Text proposed by the Commission

Amendment

(32) In certain circumstances where a significant animal or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle17 . In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

(32) In certain circumstances where a significant animal, environmental or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle17 . In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.

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17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final).

17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final).

Text proposed by the Commission

Amendment

(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, thus involving a common responsibility of all actors concerned. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are highly critical for preventing or treating life-threatening infections in humans and their use on animals, whether or not covered by the terms of a marketing authorisation, should be prohibited. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that measures are proportionally applied in both the human and animal sectors and that appropriate warnings and guidance are included on the labels of human and veterinary antimicrobials. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.

Text proposed by the Commission

Amendment

(34a) The routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing and sound management practices.

Text proposed by the Commission

Amendment

(35) The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.

(35) The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised exceptionally where evidence is provided that the long-term benefit-risk balance of the combination is favourable.

Text proposed by the Commission

Amendment

(36) The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.

(36) The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore, the misuse of antimicrobials should not be allowed. Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.

Text proposed by the Commission

Amendment

(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it is necessary to reserve those antimicrobials for humans only. As a baseline, that should apply for the highest priority critically important antimicrobials identified by the World Health Organisation (WHO). Moreover, it should be possible to decide that other critically important antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.

Text proposed by the Commission

Amendment

(37a) As antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, action also needs to be taken in the field of human medicine, for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this Regulation.

Text proposed by the Commission

Amendment

(38a) Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for the prudent use of antimicrobials in veterinary medicine, elaborated by the Commission, need to be considered by Member States.

Text proposed by the Commission

Amendment

(38b) In order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing. That would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and therefore, inhibit the development of antimicrobial resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.

Text proposed by the Commission

Amendment

(39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies.

(39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, the Union should be active in advocating the creation of an international strategy to combat antimicrobial resistance, in line with the recent Global Action Plan adopted by the WHO.

Text proposed by the Commission

Amendment

(40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

(40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. Better data are needed on how, when, where and why antimicrobials are being used. Therefore, the data collected should be broken down by type of antimicrobial, species, disease or infection treated. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.

Text proposed by the Commission

Amendment

(40a) Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies or those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information.

Text proposed by the Commission

Amendment

(49) It is necessary, in specific cases, or from a public health and animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

(49) In specific cases it is necessary, from a public health, animal health or environmental perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.

Text proposed by the Commission

Amendment

(50) A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities.

(50) A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities and other concerned authorities, including environmental protection agencies and food safety authorities both on national and Union level.

Text proposed by the Commission

Amendment

(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.

(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by veterinarians or other persons authorised to do so by the Member State where they are established. However, Member States which do not allow prescriptions to be issued by persons other than veterinarians could refuse to recognise prescriptions issued by persons other than veterinarians in other Member States in accordance with their national laws. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products, except for antimicrobials, via the Internet to buyers in their own or other Member States. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited.

Text proposed by the Commission

Amendment

(56a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, the professionally qualified animal medicines advisorsshould continue to prescribe and supply certain veterinary medicines.

Text proposed by the Commission

Amendment

(56b) Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of a key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases.

Text proposed by the Commission

Amendment

(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty.

(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. A system should be introduced to ensure that such products are properly sold and that controls are placed on the distribution and falsification of substances that are potentially dangerous for human use. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level. To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited. Member States might impose conditions for supplying medicinal products to the public within the limits of the Treaty.

Text proposed by the Commission

Amendment

(58a) Member States should, after informing the Commission, be able to subject the supply of veterinary medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

Text proposed by the Commission

Amendment

(62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health profession for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

(62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a veterinarian or other persons authorised to do so under national law for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State, provided that the other Member State authorises persons with similar qualifications to issue prescriptions. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.

Text proposed by the Commission

Amendment

(65) The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products. In order to preserve the effectiveness of the inspections, authorities should have the possibility to perform unannounced inspections.

(65) The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and should publish annual control reports. In order to preserve the effectiveness of the inspections, authorities should perform a certain percentage of unannounced inspections, which percentage should be determined by the Commission by way of a delegated act.

Text proposed by the Commission

Amendment

(67) In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. To ensure a harmonised approach to inspections throughout the Union, the Commission should be able to carry out audits in the Member States to verify the functioning of national control systems.

(67) In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. The Commission should ensure a harmonised approach to inspections throughout the Union, and should be able to carry out audits in the Member States to verify the functioning of national control systems.

Text proposed by the Commission

Amendment

(71) Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.

(71) Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules. Furthermore, it is desirable to generally allow, under specific conditions, the use of homeopathic medicinal products designed for human use, including immunological homeopathic products that have a potency starting from D4, on all animals, including food producing animals.

Text proposed by the Commission

Amendment

(71a) The usual rules governing the authorisation to market veterinary medicinal products should be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which might present risks which should be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify these rules to the Commission.

Text proposed by the Commission

Amendment

This Regulation lays down rules for the placing on the market, manufacture, import, export, supply, pharmacovigilance, control and use of veterinary medicinal products.

This Regulation lays down rules for the placing on the market, development, manufacture, import, export, wholesale distribution, retail supply, pharmacovigilance, control and use of veterinary medicinal products.

Text proposed by the Commission

Amendment

1a. Member States may impose stricter conditions, justified on grounds of public health, animal health and environmental protection, for the use and retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.

Text proposed by the Commission

Amendment

1b. The Member States shall notify the measures referred to in paragraph 1a to the Commission.

Text proposed by the Commission

Amendment

(ea) substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them;

Text proposed by the Commission

Amendment

(eb) medicated feed and intermediate products as defined, respectively, in points (a) and (b) of Article 2.2 of Regulation (EÚ) .../... of the European Parliament and of the Council 1a+;

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1a Regulation (EÚ) .../... of the European Parliament and the Council of ... on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (OJ L ...).

+ OJ: Please insert the number in the text, and in the footnote, the number, date and publication reference of document COD 2014/0255.

Text proposed by the Commission

Amendment

(ec) feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.

Text proposed by the Commission

Amendment

(b) its purpose is to be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(b) it may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

Text proposed by the Commission

Amendment

(c) its purpose is to be used for euthanasia of animals;

(c) it may be used for euthanasia in animals;

Text proposed by the Commission

Amendment

(2) ‘substance' means any matter of the following origin:

(2) ‘substance' means any matter irrespective of its origin which may be:

Text proposed by the Commission

Amendment

(a) human,

(a) human, for example human blood and human blood products;

Text proposed by the Commission

Amendment

(b) animal,

(b) animal, for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

Text proposed by the Commission

Amendment

(c) vegetable,

(c) vegetable, for example micro-organisms, plants, parts of plants, vegetable secretions, extracts;

Text proposed by the Commission

Amendment

(ca) fungal;

Text proposed by the Commission

Amendment

(cb) microbial;

Text proposed by the Commission

Amendment

(d) chemical;

(d) chemical, for example elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

Text proposed by the Commission

Amendment

(da) mineral.

Text proposed by the Commission

Amendment

(2a) ‘active substance‘ means a substance with a pharmacological activity;

Text proposed by the Commission

Amendment

(7) ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;

(7) ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; a homeopathic veterinary medicinal product may contain a number of active ingredients;

Text proposed by the Commission

Amendment

(7a) ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

Text proposed by the Commission

Amendment

(8) ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species;

(8) ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to halt the growth of or kill microorganisms of the same species;

Text proposed by the Commission

Amendment

(8a) ʻantimicrobialʼ means any compound with a direct action on micro-organisms used for treatment or prevention of infections; antimicrobials include anti-bacterials, anti-virals, anti-fungals and anti-protozoals; in the context of this Regulation, an antimicrobial substance refers to an antibacterial;

Text proposed by the Commission

Amendment

(8b) 'antiparasitic' means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes;

Text proposed by the Commission

Amendment

(8c) ʻantibacterialʼ means a compound with a direct action on bacteria used for treatment or prevention of infections;

Text proposed by the Commission

Amendment

(9) ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof;

(9) ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice;

Text proposed by the Commission

Amendment

(10) 'pre-clinical study' means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;

(10) 'pre-clinical study' means a study not covered by the definition of clinical trial;

Text proposed by the Commission

Amendment

(11) ‘benefit-risk balance' means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

(11) 'benefit-risk balance' means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:

Text proposed by the Commission

Amendment

(12) ‘common name' means the international non-proprietary name recommended by the World Health Organisation for a veterinary medicinal product, or, if one does not exist, the name generally used;

(12) 'common name' means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name;

Text proposed by the Commission

Amendment

(18) ‘package leaflet' means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;

(18) 'package leaflet' means an information leaflet which attached to a veterinary medicinal product which is intended for a user of the veterinary medicinal product and which contains information to ensure its safe and efficacious use which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product;

Text proposed by the Commission

Amendment

(21) ‘pharmacovigilance' means the process of monitoring and investigating adverse events;

(21) 'pharmacovigilance' means scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of adverse events which include continuous evaluation of the risk-benefit balance of veterinary medicinal products;

Text proposed by the Commission

Amendment

(24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law;

(24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law once a veterinary diagnosis has been established following a clinical examination of the animal or in the light of continuous health checks on the animal;

Text proposed by the Commission

Amendment

(26) ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(26) ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;

Text proposed by the Commission

Amendment

(27a) ‘essentially similar product‘ means a generic product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent to the original product, unless it is apparent in the light of scientific knowledge that it differs from the original product as regards safety and efficacy;

Text proposed by the Commission

Amendment

(27b) ʻmarketing authorisation holderʻ means the holder of a marketing authorisation granted in accordance with this Regulation;

Text proposed by the Commission

Amendment

(27c) ʻgood animal husbandryʼ means the management and care of farm animals by humans for profit whilst ensuring the health and welfare of these animals by respecting and safeguarding the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;

Text proposed by the Commission

Amendment

(27d) ʻresponsible use of veterinary medicinal productsʼ means ensuring good husbandry and management practices such as biosecurity measures aiming to keep groups of animals healthy or to limit the spread of disease within an animal population, as well as asking veterinary advice, following vaccination programmes and prescription instructions, and ensuring good hygiene, appropriate nutrition and regular monitoring of health and welfare;

Text proposed by the Commission

Amendment

(27e) ʻadverse eventsʻ means any of the undesirable events set out in Article 73(2);

Text proposed by the Commission

Amendment

(27f) ʻserious adverse eventsʻ means any adverse events which result in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or which results in permanent or prolonged signs in the animals treated;

Text proposed by the Commission

Amendment

(27h) ʻcontrol treatment (metaphylaxis)ʼ means the treatment of a group of animals after the diagnosis of clinical disease in part of the group, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk which may already be subclinically infected; the presence of such a disease in the group shall be established before the product is used;

Text proposed by the Commission

Amendment

(27l) 'wholesale distribution' means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in accordance with applicable national law;

Text proposed by the Commission

Amendment

(27m) 'name of veterinary medicinal product' means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;

Text proposed by the Commission

Amendment

(27n) 'pre-mix for medicated feedingstuffs' means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs in accordance with Regulation (EU) .../... of the European Parliament and of the Council+.

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+ OJ: please insert the number in the document 2014/0255(COD).

Text proposed by the Commission

Amendment

1. A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority in accordance with Articles 44, 46 or 48 or by the Commission in accordance with Article 40.

1. Without prejudice to other provisions of this Regulation, a veterinary medicinal product shall be placed on the market of a Member State only when a marketing authorisation has been granted in respect of the product by a competent authority of that Member State or by the Commission in accordance with this Regulation.

Text proposed by the Commission

Amendment

2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.

2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time, unless risks to public health, animal health and the environment are detected or new scientific knowledge gives grounds for re-examination of the benefit risk balance. In such situations Member States or the Commission shall refer the matter to the Agency in accordance with the procedure described in Article 84.

When a previously authorised veterinary medicinal product has not been present on the market in any Member State for a period of five consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid.

The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant an exemption from the termination of validity referred to in the second subparagraph. Such exemptions shall be duly justified.

The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of its legal responsibility.

Text proposed by the Commission

Amendment

(c) the mutual recognition procedure laid down in Articles 47 and 48.

(c) the mutual recognition procedure laid down in Articles 47, 48 and 57.

Text proposed by the Commission

Amendment

3. Applications shall be submitted electronically. For applications submitted in accordance with the centralised marketing authorisation procedure, the formats made available by the Agency shall be used.

3. Applications shall be submitted electronically or saved in exceptional circumstances and following agreement with a competent authority or in the case of centralised application, with the Agency. The Commission, in collaboration with the Member States and with the Agency shall adopt detailed guidelines on the format of electronic applications.

Text proposed by the Commission

Amendment

5. Within 15 days of receipt of the application, the competent authority or the Agency shall notify the applicant of whether all data required in accordance with Article 7 have been presented.

5. Without prejudice to specific provisions related to the mutual recognition procedure or the decentralised procedure, the competent authority or the Agency shall, within 15 days of receipt of the application, notify the applicant whether the formal requirements laid down in this Regulation for the application concerned have been met and whether the application can be subject to scientific assessment.

Text proposed by the Commission

Amendment

(a) documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals,

(a) documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals,

Text proposed by the Commission

Amendment

(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product.

(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food-producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease.

Text proposed by the Commission

Amendment

3. Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council22 shall be submitted in addition to the information listed in paragraph 1.

3. Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document shall be submitted in addition to the information listed in paragraph 1 of this Article certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council22 and that at least six months has elapsed from submission of such application.

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22 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

22 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

Text proposed by the Commission

Amendment

5a. When applying for renewal, publicly available, peer-reviewed scientific literature on the active pharmaceutical substance and its relevant metabolites dealing with side-effects on human health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.

Text proposed by the Commission

Amendment

2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless:

2. Member States shall not permit test animals to be used as a source of foodstuffs for human consumption unless the competent authorities have established an appropriate withdrawal period. Such period shall either:

(a) the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or

(a) be at least as long as the withdrawal period laid down in Article 117, including, where appropriate, a safety factor reflecting the nature of the substance being tested; or

(b) the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected.

(b) if maximum residue limits have been established by the Union in accordance with Regulation (EC) No 470/2009, the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs.

Text proposed by the Commission

Amendment

4a. The principles of replacement, reduction and refinement concerning the care and use of live animals for scientific purposes shall be taken into account during the design and performance of clinical trials.

Text proposed by the Commission

Amendment

6a. The holder of the clinical trial authorisation shall notify the competent authority of every serious adverse event and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information.

Text proposed by the Commission

Amendment

Labelling of the immediate packaging of veterinary medicinal products

Labelling of the immediate packaging of veterinary medicinal products

1. The immediate packaging of a veterinary medicinal product shall contain only the following information:

1. The immediate packaging of a veterinary medicinal product shall contain only the following information:

(a) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(a) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;

(b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

(c) the batch number, preceded by the word "Lot";

(c) the batch number, preceded by the word "Lot";

(d) the name or corporate name or logo name of the marketing authorisation holder;

(d) the name or corporate name or logo name of the marketing authorisation holder;

(e) the target species;

(e) the target species;

(f) the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.";

(f) the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.";

(g) special storage precautions, if any.

(g) special storage precautions, if any.

1a. In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure the safe and correct administration of the product.

2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2a. In addition, all the information listed in points (a) to (g) of paragraph 1 shall also appear in a format that is electronically readable, such as a barcode. Data shall be made available for other documentation systems through standards interface.

Text proposed by the Commission

Amendment

Labelling of the outer packaging of veterinary medicinal products

Labelling of the outer packaging of veterinary medicinal products

1. The outer packaging of a veterinary medicinal product shall contain only the following information:

1. The outer packaging of a veterinary medicinal product shall contain only the following information:

(a) the information listed in Article 9(1);

(a) the information listed in Article 9(1);

(b) the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

(b) the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;

(c) warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(c) warning that the veterinary medicinal product must be kept out of the sight and reach of children;

(d) warning that the veterinary medicinal product is for animal treatment only;

(d) a common pictogram warning that the veterinary medicinal product is for animal treatment only;

(e) recommendation to read the package leaflet;

(e) recommendation to read the package leaflet;

(f) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

(f) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;

(g) in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".

(g) in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".

1a. In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.

2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.

2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, as well as in machine-readable format, or, where appropriate, abbreviations or pictograms common throughout the Union.

3. Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.

3. Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.

Text proposed by the Commission

Amendment

Labelling of small immediate packaging units of veterinary medicinal products

Labelling of small immediate packaging units of veterinary medicinal products

By way of derogation from Article 9, small immediate packaging units shall contain only the following information:

By way of derogation from Article 9, small immediate packaging units shall contain only the following information:

(a) the name of veterinary medicinal product;

(a) the name of veterinary medicinal product;

(b) the quantitative particulars of the active substances;

(b) the quantitative particulars of the active substances, unless the product exists in only one concentration or the concentration is reflected in the name;

(c) the batch number, preceded by the word "Lot";

(c) the batch number, preceded by the word "Lot";

(d) the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp."

(d) the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.".

In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.

Text proposed by the Commission

Amendment

Package leaflet of veterinary medicinal products

Package leaflet of veterinary medicinal products

1. The package leaflet shall be available for each veterinary medicinal product and shall contain at least the following information:

1. The package leaflet shall be directly available with each veterinary medicinal product and shall contain at least the following information:

(a) the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

(a) the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;

(b) the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

(b) the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

(c) the strength and pharmaceutical form of the veterinary medicinal product;

(c) the strength and pharmaceutical form of the veterinary medicinal product;

(d) the target species, the dosage for each species, the method and route of administration and advice on correct administration, if necessary;

(d) the target species, the dosage for each species, the method and route of administration and, if necessary, advice on correct administration;

(e) the therapeutic indications;

(e) the therapeutic indications;

(f) the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

(f) the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;

(g) the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

(g) the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;

(h) special storage precautions, if any;

(h) special storage precautions, if any;

(i) information essential for safety or health protection, including any special precautions relating to use and any other warnings;

(i) information essential for safety or health protection, including any special precautions relating to use and any other warnings;

(j) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

(j) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;

(k) the marketing authorisation number;

(l) in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

(l) in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;

(m) in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".

(m) in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product";

(ma) qualitative and quantitative composition.

2. The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.

2. The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.

3. The package leaflet shall be written and designed to be clear and understandable, in terms that are comprehensible to the general public.

3. The package leaflet shall be written and designed to be clear, readable and understandable, in terms that are comprehensible to the general public.

Text proposed by the Commission

Amendment

Package leaflet of homeopathic veterinary medicinal products

Package leaflet of homeopathic veterinary medicinal products

By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:

By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:

(a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;

(a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label;

(b) name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

(b) name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;

(c) method of administration and, if necessary, route;

(c) method of administration and, if necessary, route;

(d) the expiry date, in the format "mm/yyyy", preceded by the abbreviation "Exp.";

(e) pharmaceutical form;

(e) pharmaceutical form;

(f) special storage precautions, if any;

(f) special storage precautions, if any;

(g) target species;

(g) target species, as well as dosage levels for the different target species;

(h) a special warning if necessary for the medicinal product;

(h) a special warning if necessary for the medicinal product;

(i) the batch number, preceded by the word "Lot";

(j) registration number;

(j) registration number;

(k) withdrawal period, if applicable.

(k) withdrawal period, if applicable;

(l) the statement "homeopathic veterinary medicinal product".

(l) the statement "homeopathic veterinary medicinal product".

Text proposed by the Commission

Amendment

2. For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety or efficacy. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.

2. For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety, efficacy and behaviour of residues. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.

Text proposed by the Commission

Amendment

6. A competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product.

6. The applicant shall submit to the competent authority or the Agency, on their request, safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if there are well founded reasons to believe that authorisation can result in an increased risk to the environment from the generic product as compared to the reference product.

Text proposed by the Commission

Amendment

By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product') shall satisfy the following criteria:

By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products shall satisfy the following criteria:

Text proposed by the Commission

Amendment

Reduced data requirements for applications for limited markets

Reduced data requirements for applications for limited markets

1. By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted although the quality and/or efficacy documentation required in accordance with Annex II has not been provided, if all the following conditions are met:

1. By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted even when, for objective, verifiable reasons, the applicant is unable to provide the quality and/or efficacy documentation required in accordance with Annex II, subject to the following conditions:

(a) the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

(a) the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

(b) the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

(b) the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of 3 years.

2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of five years. At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.

3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality and/or efficacy has been conducted due to the lack of comprehensive efficacy and/or quality data.

3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only limited information on its quality and efficacy has been submitted. The packaging shall bear a warning with the same information.

3a. A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.

Text proposed by the Commission

Amendment

3b. A requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product.

Text proposed by the Commission

Amendment

Data requirements for applications in exceptional circumstances

Data requirements for applications in exceptional circumstances

1. By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:

1. By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, including unmet meeds with respect to animal health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:

(a) a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

(a) a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

(b) a requirement to notify the competent authorities of any incident relating to the use of the veterinary medicinal product;

(b) a requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product;

(c) a requirement to conduct post-authorisation studies.

(c) a requirement to provide further data based on either post-authorisation studies or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on risk-benefit assessment;

2. By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be granted for a period of 1 year.

2. The continuation of a marketing authorisation granted in accordance with paragraph 1 shall be tied to an annual review of the conditions set out in that paragraph, until all the conditions are fulfilled.

3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data.

3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data. The packaging shall bear a warning with the same information.

3a. The competent authority or the Commission may at any time grant a valid marketing authorisation for an unlimited period of time, provided that no safety or efficacy problems have been reported with the product in use and the marketing authorisation holder has supplied the missing quality, safety and efficacy information set out in paragraph 1.

3b. A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.

Text proposed by the Commission

Amendment

The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1).

The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with applicable Union law , are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1) and that they minimise environmental pollution.

Text proposed by the Commission

Amendment

3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission shall require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

Text proposed by the Commission

Amendment

Requirement for a veterinary prescription

Requirement for a veterinary prescription

1. A competent authority or the Commission shall classify the following veterinary medicinal products as subject to veterinary prescription:

1. The following veterinary medicinal products shall be subject to mandatory veterinary prescription:

(a) veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

(a) veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;

(b) veterinary medicinal products for food-producing animals;

(b) veterinary medicinal products for food-producing animals;

(c) antimicrobial veterinary medicinal products;

(c) antimicrobial veterinary medicinal products;

(d) products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(d) products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(e) officinal formulae intended for food-producing animals;

(e) officinal formulae intended for food-producing animals;

(f) veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union.

(f) veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union;

(fa) veterinary medicinal products for which marketing authorisations have been granted in accordance with Article 21 and/or 22.

1a. Member States may on their territories provide for additional legal subcategories in accordance with the respective national law.

2. A competent authority or the Commission may classify a veterinary medicinal product as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:

2. A veterinary medicinal product may be classified as subject to mandatory veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:

(a) the target species,

(a) the target species,

(b) the person administering the products to the animal,

(b) the person administering the products to the animal,

(c) the environment

(c) the environment.

3. By the way of derogation from paragraph 1, a competent authority or the Agency may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled:

3. By the way of derogation from paragraph 1, a competent authority or the Commission may exempt a veterinary medicinal product from a mandatory veterinary prescription if all of the following conditions are fulfilled:

(a) the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

(a) the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

(b) the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

(b) the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;

(c) the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;

(c) the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;

(d) neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

(d) neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

(e) the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

(e) the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;

(f) the veterinary medicinal product is not subject to special storage conditions;

(f) the veterinary medicinal product is not subject to special storage conditions;

(g) there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(g) there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(h) there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.

(h) there is no risk to public or animal health as regards the development of antiparasitic resistance even where the veterinary medicinal products containing those substances are used incorrectly.

Text proposed by the Commission

Amendment

3a. Notwithstanding paragraph 1, medicinal products for veterinary use may be used without prescription if:

(a) they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000) and are not produced using alcohol;

(b) they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.

Text proposed by the Commission

Amendment

(b) qualitative and quantitative composition of the active substances or other constituents stating the common name or the chemical description of the substances or other constituents;

(b) qualitative and quantitative composition of the active substances and all the essential constituents, stating the common name or the chemical description of the substances or other constituents;

Text proposed by the Commission

Amendment

(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,

(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not allowed to be used as a routine preventive measure,

Text proposed by the Commission

Amendment

(iiia) list of excipients,

Text proposed by the Commission

Amendment

(ea) information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water;

Text proposed by the Commission

Amendment

(ja) when the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities.

Text proposed by the Commission

Amendment

2a. Where two products have the same therapeutic effect, comparative assessments may be carried out. In such a case, the products that are hazardous to the environment or to the treated animals shall be substituted by the less hazardous products having the same therapeutic effects.

Text proposed by the Commission

Amendment

(d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;

(d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals, or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals;

Text proposed by the Commission

Amendment

(e) the withdrawal period is not long enough to ensure food safety;

(e) the proposed withdrawal period to ensure food safety is not well justified, or the proposed withdrawal period by the Agency or by the competent authorities is not taken into account;

Text proposed by the Commission

Amendment

(ga) the product is a substance of high concern;

Text proposed by the Commission

Amendment

(gb) active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;

Text proposed by the Commission

Amendment

(ha) the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;

Text proposed by the Commission

Amendment

(hb) unacceptable side effects or secondary effects on the treated animal;

Text proposed by the Commission

Amendment

(ia) the veterinary medicinal product contains or is composed of organisms or viruses which, in accordance with

Annex I A to Directive 2001/18/EC, have been genetically modified.

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and taking into consideration the scientific advice of the Agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.

The Agency, in its advice, shall consider appropriate designations at the class, substance or even the indication level and shall consider also the route of administration.

Member States which implement or wish to implement stricter rules shall be allowed to do so.

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4. The Commission shall, by means of implementing acts and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Such designations, where relevant, shall be done at the class, substance or even the indication level and shall consider also the route of administration.

Text proposed by the Commission

Amendment

3. Any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.

3. Any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths, species, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.

Text proposed by the Commission

Amendment

Periods of the protection of technical documentation

Periods of the protection of technical documentation

1. The period of the protection of technical documentation shall be:

1. The period of the protection of technical documentation shall be:

(a) 10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;

(a) 10 years for the veterinary medicinal products for cattle, sheep (reared for meat), pigs, chickens, salmon, dogs and cats;

(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, salmon, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(c) 18 years for veterinary medicinal products for bees;

(c) 20 years for veterinary medicinal products for bees;

(d) 14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

(d) 14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).

2. The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.

2. The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.

2a. Where the veterinary medicinal product has been authorised for more than one species, the period shall be extended in accordance with the prolongation periods provided for in Article 35.

Text proposed by the Commission

Amendment

Article 34a

Period of protection of new data packages related to existing antimicrobial veterinary medicinal products

1. Any new studies and trials, submitted by the applicant for a marketing authorisation to the competent authorities for an existing antimicrobial veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years, provided that they are:

a) needed to extend a marketing authorisation in respect of dosages, pharmaceutical forms or routes of administration;

(b) needed for a re‑evaluation requested by the Agency or the competent authorities post-authorisation, unless they have been requested by competent authorities as a follow-up to post authorisation pharmacovigilance concerns, or requested as a condition of authorisation or as a post-authorisation commitment at the time of authorisation. Each period of protection shall operate independent from any other that may operate concurrently and shall therefore not be cumulated.

2. No other applicant may use the results of these trials or studies for commercial purposes during that four‑year period without the written consent of the holder of the marketing authorisation in the form of a letter of access to those trials or studies.

Text proposed by the Commission

Amendment

Prolongation of the periods of the protection of technical documentation

Prolongation of the periods of the protection of technical documentation

1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article shall be prolonged by 1 year for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).

1. Where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with Article 65, extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article 34 shall be prolonged by two years for each additional target species in the original dossiers, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a). The information on the submission for extension of the marketing authorisation shall be made publicly available.

2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years.

2. Where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with Article 65, extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years, provided that the variation has been submitted at least three years before the expiration of the protection period laid down in Article 34. The information on the submission for extension of the marketing authorisation shall be made publicly available.

3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ('overall period of the protection of technical documentation') shall not exceed 18 years.

3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ('overall period of the protection of technical documentation') shall not exceed 14 years for products referred to in Article 34 (1)(a). For products referred to in Article 34 (1) (b) and (d), this period shall not exceed 18 years.

4. Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use those trials for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.

4. Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use the results of these trials for commercial purposes for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.

Text proposed by the Commission

Amendment

(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

Deleted

Text proposed by the Commission

Amendment

(e) generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.

Deleted

Text proposed by the Commission

Amendment

4. The Commission, taking into account the state of animal and public health in the Union, shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend the list set out in paragraph 2.

Deleted

Text proposed by the Commission

Amendment

1. Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State').

1. Applications and the dossier for decentralised marketing authorisation shall be submitted to all the Member States. The Member State chosen by the applicant shall be the reference Member State.

Text proposed by the Commission

Amendment

2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned').

2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation ('Member States concerned'). The applicant shall send to all Member States concerned an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7 .

Text proposed by the Commission

Amendment

1. Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State').

1. Applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the Member States. The Member State that granted the first national marketing authorisation shall be the reference Member State.

Text proposed by the Commission

Amendment

2. A minimum of 6 months shall elapse between the decision granting the first national marketing authorisation and the submission of the application for mutual recognition of the national marketing authorisation.

deleted

Text proposed by the Commission

Amendment

(c) an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examination;

deleted

Text proposed by the Commission

Amendment

4. Within 90 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all Member States and the applicant, together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States').

4. Within 45 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all concerned Member States and the applicant.

Text proposed by the Commission

Amendment

1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142(‘the coordination group') by the reference Member State.

1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142 (‘the coordination group’) by the reference Member State.

Text proposed by the Commission

Amendment

2. Within the coordination group, a rapporteur shall be appointed in order to prepare a second assessment report for the veterinary medicinal product.

deleted

Text proposed by the Commission

Amendment

4. In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.

4. In the event of an opinion in favour of granting or amending a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.

Text proposed by the Commission

Amendment

1. Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the Agency requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.

1. Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the Coordination group requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination

Text proposed by the Commission

Amendment

1. A Union database on veterinary medicinal products (‘product database') shall be set up and maintained by the Agency.

1. A Union-wide database on veterinary medicinal products (‘product database') shall be set up and maintained by the Agency.

Text proposed by the Commission

Amendment

(a) veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets and lists of sites where each product is manufactured;

(a) veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured and reference numbers to the pharmacovigilance system master file;

Text proposed by the Commission

Amendment

2. Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations.

2. Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations and limited access to other products.

Text proposed by the Commission

Amendment

3. The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics and package leaflets.

3. The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics, package leaflets and their environmental data, and all safety information.

Text proposed by the Commission

Amendment

1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products.

1. Member States shall collect relevant comparable and sufficiently detailed data, at per-farm level, on the volume of sales in terms of weight and cost for each antimicrobial type and the use of veterinary antimicrobial medicinal products including the species treated, the disease diagnosed and the route of administration.

Text proposed by the Commission

Amendment

2. Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall analyse the data and publish an annual report.

2. Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall cooperate with other European agencies to analyse the data and publish an annual report which shall also include the corresponding data for human use of antimicrobials as well as the current situation on antimicrobial resistance in the Union and, where appropriate, issue guidelines and recommendations.

Text proposed by the Commission

Amendment

3a. Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency.

Text proposed by the Commission

Amendment

4a. Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route or routes. In addition, any off-label use of antimicrobials shall be mandatorily reported to national authorities.

Text proposed by the Commission

Amendment

4b. The use of antibiotics in drinking water shall be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance.

Text proposed by the Commission

Amendment

Article 57a

Subsequent conversion into centralised marketing authorisation

1. After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission which shall be valid throughout the Union.

2. The application for the conversion into a centralised marketing authorisation shall be submitted to the Agency and shall include the following:

(a) a list of all decisions granting marketing authorisations concerning this veterinary medicinal product;

(b) a list of variations introduced since the first marketing authorisation in the Union was granted;

(c) a summary report on pharmacovigilance data.

3. Within 30 days of receipt of the documents listed in paragraph 2, the Commission shall prepare a draft of the decision granting the Union marketing authorisation in conformity with the assessment report referred to in Articles 46(3), 48(4) and 69(3) or, where appropriate, an updated assessment report, a summary of the product characteristics, and a labelling and package leaflet.

4. The Commission shall, by means of implementing acts, take a final decision on the granting of the centralised marketing authorisation.

This Article shall only apply to veterinary medicinal products that have been authorised through a mutual recognition procedure, a decentralised procedure or a marketing authorisation harmonisation procedure after the date of the application of this Regulation.

Text proposed by the Commission

Amendment

1. If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application.

1. If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application in 15 days.

Text proposed by the Commission

Amendment

Preparatory phase of the harmonisation exercise

Preparatory phase of the harmonisation exercise

-1a. A single marketing authorisation holder or a group of marketing authorisation holders may, in accordance with Article 69, request a harmonisation of different national marketing authorisations that have been granted for a particular veterinary medicinal product.

-1b. A harmonised summary of product characteristics shall be prepared for the particular veterinary medicinal product, for which national marketing authorisations have been granted in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation.

-1c. National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product or for essentially similar products

1. A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different Member States before 1 January 2004 (‘similar products’).

1. Harmonised conditions of use as set out in Article 69(4) shall be prepared in accordance with the procedure laid down in Article 69 for groups of essentially similar veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio-equivalent ('essentially similar' products) and for which national marketing authorisations have been granted in different Member States before the entry into force of this Regulation.

2. For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.

2. For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.

Text proposed by the Commission

Amendment

Procedure for harmonisation of summaries of products characteristics

Procedure for harmonisation of summaries of products characteristics

1. By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 January 2004.

1. By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted.

2. The coordination group shall establish groups of similar products. For each of the groups of similar products, the coordination group shall appoint one member to act as a rapporteur.

2. The coordination group shall establish groups of essentially similar products as identified in point (b) of Article 68(4). For each of these groups of essentially similar products, the coordination group shall appoint one member to act as a rapporteur.

3. Within 120 days of his appointment, the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics.

3. Within 120 days of his appointment, the rapporteur shall present to the coordination group a report proposing harmonisation of the conditions of use for the group of essentially similar veterinary medicinal products or of the marketing authorisation of a particular veterinary medicinal product.

4. Harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information:

4. Harmonised conditions of use shall contain at least the following information:

(a) all species mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;

(a) all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;

(b) all therapeutic indications mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;

(b) all therapeutic indications and posology mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;

(c) the shortest withdrawal period of those stated in the summaries of the product characteristics.

(c) a withdrawal period which ensures that consumers are adequately protected ;

(ca) special precautions regarding impact on the environment.

4a. Further than the conditions of use, other elements of the summary of product characteristics and data quality set, may be harmonised.

5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.

5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.

6. In the event of an opinion in favour of adopting a harmonised summary of the product characteristics, each Member State shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur.

6. In the event of an opinion in favour of adopting harmonised conditions of use, each Member State shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4, where they are already included in the summaries of characteristics for a product belonging to that group, are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. Once an opinion in favour of adopting harmonised conditions of use has been issued, marketing authorisations for a particular product shall be eligible to be considered to be mutual recognition marketing authorisations granted under this Regulation.

7. In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.

7. In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.

Text proposed by the Commission

Amendment

Harmonisation of summary of products characteristics following reassessment

Harmonisation of summary of products characteristics following reassessment

1. By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised summary of the product characteristics is prepared.

1. By way of derogation from Article 69, and where harmonisation of the conditions of use of a group of products is in the interests of public or animal health at Union level, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before harmonised conditions of use are prepared.

1a. For the purpose of harmonisation under this Article similar veterinary medicinal products shall refer to products, not all of which are bioequivalent, and other than homeopathic veterinary medicinal products, that have the same active substance or active substances and the same pharmaceutical form or a range of veterinary medicinal products belonging to the same therapeutic class.

2. The Commission shall, by means of implementing acts, adopt decisions on groups of product for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2. The Commission shall, by means of implementing acts, adopt decisions on groups of similar products for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3. By way of derogation from Article 69, veterinary medicinal products authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed before a harmonised summary of the product characteristics is prepared.

3. By way of derogation from Article 69, veterinary medicinal products which have not been subject to an environmental risk assessment in the Union shall be assessed in accordance with Annex II before harmonised conditions of use are prepared. For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in Article 7(1)(b).

3a. By way of derogation from Article 69, antimicrobial veterinary medicinal products shall be reassessed within five years of the entry into force of this Regulation.

4. For the purposes of paragraphs 1 and 3, the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.

4. For the purposes of paragraphs 1, 3 and 3a the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.

Text proposed by the Commission

Amendment

Position of marketing authorisation holder

Position of marketing authorisation holder

Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products.

Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of products identified for a harmonisation of the summaries of the product characteristics or the holders of a particular product identified for harmonisation of marketing authorisations shall submit information concerning their products

Text proposed by the Commission

Amendment

1. Marketing authorisation holders shall elaborate and maintain a system for collecting information on the risks of veterinary medicinal products as regards animal health, public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system').

1. Marketing authorisation holders shall ensure that risk-benefit balance of authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order ensure that this balance remains positive for the authorised veterinary medicinal products. To this end, the marketing authorisation holders shall elaborate and maintain a system for collecting, investigating, assessment and communicating of information on the adverse events of veterinary medicinal products as regards animal health, public health and the environment. The system shall serve to coordinate the necessary measures to fulfil the pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system').

Text proposed by the Commission

Amendment

2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders.

2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and shall not have any conflict of interest with regard to the marketing authorisation holder.

Text proposed by the Commission

Amendment

1. Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor the safety of authorised veterinary medicinal products, enabling them to fulfil their responsibilities as listed in Articles 77 and 79 (‘Union pharmacovigilance system’).

1. Member States, the Commission and the Agency shall collaborate in setting up, interconnecting and further developing their systems to monitor the safety, effectiveness and quality of authorised veterinary medicinal products in order to fulfil their responsibilities as listed in Article 79. Marketing authorisation holders shall set up and maintain a system to monitor the safety, effectiveness and quality of their products, enabling them to fulfil their responsibilities as listed in Articles 77 and 78.

Text proposed by the Commission

Amendment

2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the following events whether or not the event is considered to be product-related (‘adverse events’):

2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals, animal holders, environmental authorities of the Member States and other interested parties different means of reporting to them the following events (‘adverse events’) whether or not the event is considered to be product-related:

(a) any response in an animal to a veterinary or human medicinal product, that is noxious and unintended;

(a) any response in an animal to a veterinary or human medicinal product, that is noxious and unintended, regardless of whether or not the event is considered to be product-related and whether or not the product was administered in accordance with the summary of product characteristics;

(b) any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics;

(b) any observation of a lack of efficacy of a veterinary medicinal product, including potential signs of antimicrobial resistance, following its use on an animal;

(c) any environmental incidents observed following administration of a veterinary medicinal product to an animal;

(c) any adverse, unforeseen, or unintended impact in the environment (including ground and surface water) following administration of a veterinary medicinal product to an animal;

(d) any infringements of withdrawal period following administration to an animal of a veterinary or human medicinal product;

(d) any infringements of withdrawal period following administration to an animal of a veterinary medicinal product;

(e) any noxious response in humans to a veterinary medicinal product;

(e) any noxious reaction in humans to a veterinary medicinal product;

(f) any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009.

(f) any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009;

(fa) any suspected unintended transmission via a veterinary medicinal product of any infectious agent.

Text proposed by the Commission

Amendment

2a. Competent authorities and the Agency shall, in addition to the events provided under paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product.

Text proposed by the Commission

Amendment

Article 73a

No later than six months before the date of application of this Regulation, the Commission shall present a report to the European Parliament and the Council on a feasibility study of a substance-based review system ('monographs') and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.

Text proposed by the Commission

Amendment

2. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database.

2. The Agency shall, in consultation with the Member States, the Commission and interested parties, draw up the functional specifications for the pharmacovigilance database. These shall include environmental monitoring data which would report undesirable effects on non-target species in the ecosystem, and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians.

Text proposed by the Commission

Amendment

3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with Article 75.

3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with Article 75.

Text proposed by the Commission

Amendment

3a. The Agency shall ensure that the transfer of information between its pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded.

Text proposed by the Commission

Amendment

(a) the number of adverse events reported each year, broken down by product, animal species and type of adverse event;

(a) the number of adverse events reported each year, broken down by type of product and active substance, animal species and type of adverse event;

Text proposed by the Commission

Amendment

(ba) information about incidence of adverse events.

Text proposed by the Commission

Amendment

1. Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report.

1. Competent authorities shall record and assess all adverse events of which they learn under Article 73 and which occur in the territory of their Member State and shall enter them immediately, but no later than 15 days following the receipt of the information, in the pharmacovigilance database. Competent authorities shall record any serious adverse event in animals, noxious response in humans to a veterinary medicinal product or environmental incident observed following administration of a veterinary medicinal product to an animal within 15 days following the receipt of such an adverse event report.

Text proposed by the Commission

Amendment

2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report.

2. Marketing authorisation holders shall record in the pharmacovigilance database and evaluate all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report. Less serious adverse events relating to the use of veterinary medicinal products shall be reported no later than 42 days following receipt of the information. Different requirements shall apply for adverse events observed in clinical trials, as specified in the Good Clinical Practice guidelines for clinical trials.

Text proposed by the Commission

Amendment

3. Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.

3. Competent authorities may, on their own initiative or on a request from the Agency, request the marketing authorisation holder to provide specific pharmacovigilance data, such as, information relating to ongoing risk-benefit balance evaluations regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, or the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.

Marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority.

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation.

1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events.

Text proposed by the Commission

Amendment

2. Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party, those arrangements shall be set out in details in the pharmacovigilance system master file.

2. Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party (contractor), the responsibilities of both parties shall be set out explicitly in a contract and in the pharmacovigilance system master file.

Text proposed by the Commission

Amendment

2a. The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the requirements of the contract.

Text proposed by the Commission

Amendment

3. The marketing authorisation holder shall permanently have at his disposal one or more appropriately qualified persons responsible for pharmacovigilance. Those persons shall reside and operate in the Union. Only one qualified person shall be designated by the marketing authorisation holder per pharmacovigilance system master file.

3. The marketing authorisation holder shall permanently have at his disposal an appropriately qualified person responsible for pharmacovigilance. That person shall reside and operate in the Union. The qualified person responsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder’s pharmacovigilance system and for the safety profile of his veterinary medicinal products.

Text proposed by the Commission

Amendment

4. Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, those arrangements shall be detailed in the contract.

4. Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, the relevant arrangements shall be set out explicitly in a contract.

Text proposed by the Commission

Amendment

6. The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.

6. The marketing authorisation holder shall not communicate information regarding adverse events and potential pharmacovigilance concerns to the general public in relation to the veterinary medicinal product without sending in advance a copy of that communication to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.

Text proposed by the Commission

Amendment

Qualified person responsible for pharmacovigilance

Qualified person responsible for pharmacovigilance

Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall carry out the following tasks:

Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall ensure that the following tasks are carried out :

(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;

(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder (‘pharmacovigilance system master file’) for all products under their responsibility;

(b) allocating reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file of each product to the product database;

(b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file to the product database for each product;

(c) notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;

(c) notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;

(d) establishing and maintaining a system which ensures that all adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

(d) establishing and maintaining a system which ensures that all adverse events, including on non-target species and the environment, which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

(e) preparing the adverse event reports referred to in Article 76;

(e) preparing the adverse event reports referred to in Article 76;

(f) ensuring that collected adverse event reports are recorded in the pharmacovigilance database;

(f) ensuring that collected adverse event reports are recorded in the pharmacovigilance database;

(g) ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;

(g) ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;

(h) providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

(h) providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

(i) evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;

(i) evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;

(j) monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;

(j) monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;

(k) ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training;

(k) ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training tailored to their duties, on an ongoing basis; training courses are documented and their effectiveness reviewed;

(l) communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information.

(l) communicating any regulatory measure that is taken in another Member State or a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information;

(la) conducting for each product an annual risk-benefit review taking into account all pharmacovigilance surveillance data available on the product concerned, including pharmacovigilance signal monitoring. This review shall be documented by the marketing authorisation holder and the outcome recorded in the pharmacovigilance database. The marketing authorisation holder shall provide the documentation supporting the outcome of the review on request from the national competent authority or during the conduct of an inspection carried out in accordance with Article 128;

(lb) the authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and further develop the pharmacovigilance system and to ensure compliance with requirements.

Text proposed by the Commission

Amendment

1. Competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.

1. Competent authorities shall evaluate all adverse events reported to them by marketing authorisation holders, healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.

Text proposed by the Commission

Amendment

4. Competent authorities and the Agency shall provide the general public, veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.

4. Competent authorities and the Agency shall make public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication. Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported.

Text proposed by the Commission

Amendment

5. Competent authorities shall verify by means of inspections referred to in Article 125 that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.

5. Competent authorities shall verify by means of inspections referred to in Article 125 or any other way that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.

Text proposed by the Commission

Amendment

1. A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent authority in another Member State subject to the written agreement of the latter.

1. A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent public authority in another Member State subject to the written agreement of the latter.

Text proposed by the Commission

Amendment

Signal management process

Signal management process