Subsection 3: Apprenticeship programme authorisation procedure

The application for authorisation referred to in Article L. 1161-5 is sent by the company exploiting the medicinal product to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It shall mention : 1° The name and address of the applicant for authorisation and, where applicable, those of the marketing authorisation holder ; 2° The name of the medicinal product, including its international…

The application is accompanied by a dossier comprising: 1° The summary of product characteristics and the package leaflet; 2° The name and address of the registered office of the chosen operator; 3° All the elements making up the programme; 4° The arrangements for implementing the programme; 5° The number of patients concerned, as estimated by the company marketing the medicinal product; 6° The follow-up report referred to in article R….

I. – The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) decides on the application for authorisation after receiving the opinion of one or more associations mentioned in Article L. 1114-1 and concerned by the disease. If the application is incomplete, the procedure is suspended until the additional information required has been…

The authorisation is issued for a period of three years and may be renewed for an identical period on application by the authorisation holder to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, no later than six months before its expiry date. Any renewal of authorisation is examined under the same conditions as the initial authorisation, and after transmission to the Agence…

The withdrawal or suspension of the authorisation is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The company exploiting the medicinal product is given the opportunity to submit its written observations. In urgent cases, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation for a period of three months.

Any change to any of the elements of the application for authorisation of the programme will give rise to a new authorisation, issued under the same conditions as the initial authorisation.

Decisions to authorise or withdraw authorisation taken in application of Article L. 1161-5 are published on the Agency’s website. Decisions to withdraw programme authorisation may be accompanied by an obligation to provide information, the content of which has been approved in advance by the Agence nationale de sécurité du médicament et des produits de santé, and distributed by the operator, at its own expense, to the healthcare professionals, associations and…