Section 5: Marketing authorisation

When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation conducted with a view to this authorisation, an application for authorisation of the same change for another medicinal product containing the same active substance may not refer to these studies for a period of one year. In this case,…

1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and time limits, vary the marketing authorisation where it is necessary to update it in the light of scientific knowledge….

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the reasons on which they are based and indicate the appeal procedures and time limits applicable.

The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The applicant must complete a trial programme within a period set by the Agency, the results of which will be used to reassess the benefit/risk balance of the medicinal product as defined in the first paragraph of article…

The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The application for renewal is accompanied by a consolidated version of the dossier containing administrative information and data relating to the quality, safety and efficacy of the medicinal product, including an assessment of the data contained in the reports…

Any change in the marketing authorisation holder is subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The application must include the information specified in Article R. 5121-21 and must be accompanied by a dossier comprising : 1° A copy of the marketing authorisation, certified by the holder ; 2° The agreement of the marketing authorisation holder to the…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend, for a period not exceeding one year, or withdraw a marketing authorisation on the grounds mentioned in Article L. 5121-9. However, where the authorisation is suspended, either as a precautionary measure pending the outcome of a European Union arbitration…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may prohibit the prescription and supply of a proprietary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may only be taken after the proprietor has been invited to present his…

When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human health or the environment, pending a final decision by the European Commission, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the use of a medicinal product…

The Director General of the Agence de sécurité du médicament et des produits de santé (Agency for the Safety of Medicines and Health Products) makes public, in particular via the Agency’s website: 1° The decisions to grant marketing authorisation for medicinal products or products which he has issued, accompanied by the corresponding summary of product characteristics, the package leaflet, any conditions set in application of the third paragraph of article…