Part five: Health products

During the examination of marketing authorisation applications, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may order any investigative measure he deems necessary and in particular: 1° Carry out any investigation relating to the manufacture of the medicinal product ; 2° Consult the experts who have been chosen to carry out the tests with a view to compiling the marketing authorisation application…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will make a decision within two hundred and ten days of the submission of a complete application file. When the Director General of the Agency makes use of the option granted to him under 5° of Article R. 5121-34, these time limits are suspended until the additional information required has been provided. The Director…

The marketing authorisation is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The authorisation includes the national number identifying the presentation of the medicinal product provided for in Article R. 5121-4. It indicates, where applicable, the classification of the medicinal product in the following categories: 1° Medicinal product subject to prescription by virtue of its inclusion on one of the…

The marketing authorisation may impose one or more of the following conditions, which must be mentioned in the risk management system: 1° The implementation of measures to ensure the safe use of the medicinal product or product; 2° The performance of post-authorisation safety studies; 3° Compliance with specific obligations regarding the recording or reporting of suspected adverse reactions; 4° Any other condition or restriction intended to ensure the safe and…

The marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that: 1° That it is not followed by the marketing of the medicinal product on national territory within three years of its issue; 2° That the medicinal product, previously marketed on national territory, is no longer marketed for three consecutive years. A derogation from these provisions may be granted…

After the marketing authorisation has been granted, the authorisation holder must, with regard to the manufacturing and control methods, take account of scientific and technical progress and introduce any changes necessary to ensure that the medicinal product is manufactured and controlled in accordance with recognised scientific methods. These modifications must first be authorised under the conditions set out in article R. 5121-41-1.

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.