Chapter I: General provisions

When a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, is also subject to authorisation. All these authorisations are considered to be…

When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scientific evaluation conducted with a view to this authorisation, for a medicinal product whose active substance has been in well-established medicinal use for at least ten years in France, in the European Community or in the European Economic Area,…

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…