Subsection 3: Examination and conditions of authorisation.

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…

Without prejudice to the provisions of 2° of Article R. 5121-50, each year the Agence nationale de sécurité du médicament et des produits de santé publishes on its website the list of medicinal products or products for which marketing authorisations have been refused, withdrawn or suspended in France, the supply of which has been prohibited or which have been withdrawn from the market, stating the reasons for these measures. It…