Any pharmaceutical specialty or any other drug manufactured industrially or according to a method involving an industrial process as well as any generator, kit or precursor which is not the subject of a marketing authorization issued by the European Union in application of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 establishing Community procedures for the authorization and supervision with regard to medicinal products for human and veterinary use, and establishing A European Medicines Agency must, before it is placed on the market or its distribution free of charge, be the subject of a marketing authorization issued by the National Agency for the Safety of Medicines and Health Products. The authorization may be subject to appropriate conditions, in particular the obligation to carry out post-authorization safety or efficacy studies.
The authorization requester may be exempted from producing certain data and studies under conditions set by regulation.
A marketing authorization can only be issued to an applicant established in a Member State of the European Union or party to the Agreement on the European Economic Area.
The authorization is issued for a period of five years and can then be renewed, if necessary, without limitation of duration, under conditions fixed by a decree in the Council of State, except if the National Agency for Medicines Safety and health products decides to carry out a five-year renewal, on the basis of a reassessment of the positive therapeutic effects of the drug or product with regard to the risks as defined in the first paragraph of article L. 5121-9. This decree also determines the conditions under which it can lapse.
The authorization can be modified by the National Agency for the Safety of Medicines and Health Products.
Completion of the formalities provided for in this article does not have the effect of exonerating the manufacturer and, if he is distinct, the holder of the marketing authorization, from the responsibility that one or the other may incur under the conditions of common law by reason of the manufacture or the placing on the market of the drug or product.
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Law n ° 2011-2012 of December 29, 2011 article 41 III: These provisions come into force on a date provided for by the decree adopted for their application and no later than August 1, 2012. From this entry into force, the National Agency Medicines and Health Products Safety Authority exercises all rights and supports all obligations of the French Agency for Health Product Safety. Until the entry into force of these provisions, the powers and powers that this law confers on the National Agency for the Safety of Medicines and Health Products are exercised by the French Agency for the Safety of Health Products.
Decree n ° 2012-597 of April 27, 2012 entered into force on May 1, 2012.
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