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Parliamentary questions
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29 March 2011
Answer given by Mr Dalli on behalf of the Commission
Question reference: E-001144/2011

The EU's legislation on medicinal products does not define specific requirements related to bacteriophage therapy or medicines composed of bacteriophages.

Bacteriophages could be regulated as any other medicinal product if the product fulfils the definition of a medicinal product, namely:

any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

The classification of any given product as a medicinal product is performed by the Member States taking into account all the characteristics of the product. When a product is classified as a medicinal product, such product may be placed on the EU market only after a marketing authorisation for such product has been delivered. In order to obtain a marketing authorisation, an application which meets the requirements laid down in Directive 2001/83/EC(1), as amended, has to be submitted. If the active substance is a biological substance that is produced by or extracted from a biological source, then specific requirements are required in the marketing authorisation dossier and are defined in Directive 2001/83/EC Annex I, Part III.

In addition, if the product is based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering), the medicinal product is eligible as an advanced therapy medicinal product. In such cases, specific rules as established in Regulation (EC) No 1394/2007(2) apply. All data shall allow the competent authority to draw a conclusion on the quality, efficacy and safety of the product and the positive benefit/risk balance for the patients. The product is then authorised to be placed on the market.

The Commission considers that the existing regulatory framework as explained above is adequate for bacteriophage therapy without the need for an extra set of documentation for bacteriophage therapy.

(1)OJ L 311, 28.11.2001.
(2)OJ L 324, 10.12.2007.

OJ C 286 E, 30/09/2011
Právní upozornění - Ochrana soukromí