Section 5: Marketing authorisation

After the marketing authorisation has been granted, the marketing authorisation holder must immediately forward to the National Agency for the Safety of Medicines and Health Products, indicating the scope of the information, any new data which it has or becomes aware of which could lead to a change in the assessment of the risk-benefit balance of the medicinal product or product as defined in the first paragraph of Article L….

Following the granting of a marketing authorisation, including for an authorisation granted before 21 July 2012, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision notified in writing, where he has concerns about the risks associated with the authorised medicinal product or product, require the holder of this authorisation to implement a risk management system, together with a detailed…

After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carry out one or more post-authorisation safety or efficacy studies, or specific monitoring of the risk, its complications and its medico-social management, as provided for in Article L. 5121-8-1. The Director General of the Agency may request that these studies…

The Minister for Health may, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, require by order that companies exploiting certain immunological medicinal products mentioned in article L. 5121-1 submit to the National Agency for the Safety of Medicines and Health Products a copy of all control reports signed by the responsible pharmacist.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.

For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product for its inspection before the batch is put into circulation when it operates : 1° A live vaccine ; 2° An immunological medicinal product used for the primary immunisation of young children or persons belonging to…

In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples either of the bulk product and the finished product, or of one of them only. In the interests of public health, the Agence nationale de sécurité du médicament et des produits de santé may require a company exploiting a blood-derived medicinal…

The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package leaflet, other than amendments to the summary of product characteristics. If the Director General of the Agency has not made a decision within ninety days of the date of submission of the application, the applicant may proceed to implement…

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,…