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Parliamentary questions
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15 March 2019
E-000315/2019(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-000315/2019

1. The Commission has taken note of the report of France Assos Santé. The reasons for shortages include manufacturing problems, quotas from industry, legal parallel trade, or economic reasons such as the price of medicines, which falls under the competence of the Member States.

According to EU medicines legislation, there is an obligation for companies to ensure continuous supply of medicines to cover the needs of patients once a product is placed on a specific EU market(1). Furthermore, in specific circumstances, the deliberate creation of medicines shortages, for example in the sense of a refusal to supply, may constitute an infringement of both European and national competition rules. The Commission and/or national authorities are closely following this issue and can further investigate and take enforcement measures in individual cases.

2. Marketing authorisation holders must, other than in exceptional circumstances, inform Member States’ authorities at least two months in advance if they plan to withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal(2). There is also an obligation of continuous supply to cover the needs of patients once a medicine product is placed on a specific EU market and an obligation to comply with competition rules. The sudden withdrawal of marketing authorisations should, therefore, not be a common occurrence. There is, however, no obligation to market medicines in a particular or all Member State(s) by pharmaceutical companies.

As mentioned above, EU legislation(3) requires an authorisation to manufacture or import medicines and active ingredients. There is no requirement in the marketing authorisation regarding the number of manufacturing sites.

(1)Article 81 of Directive 2001/83/EC.
(2)Article 23a of Directive 2001/83/EC.
(3)https://ec.europa.eu/health/human-use/legal-framework_en

Last updated: 18 March 2019Legal notice