Section 5: Marketing authorisation

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.