Information on learning programmes must be dissociated from any promotional communication relating to the medicinal product covered by the programme and may not be the subject of any direct communication to the public.
The authorisation of the learning programme covers the elements of the programme, the procedures for its implementation and the choice of operator. It is subject to the following conditions: 1° The existence of a benefit for a patient suffering from a medical condition whose medicinal treatment requires technical gestures, particularly in the case of chronic treatment; 2° The appropriateness of the programme to the requirements of learning the technical gesture,…
Only medicinal products which have obtained a marketing authorisation issued by the European Union in application of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency or a marketing authorisation issued by the Agence nationale de sécurité du médicament et…
The elements of the programme include in particular: 1° The name of the medicinal product, together with its international non-proprietary name; 2° Information essential for the appropriation of the technical procedures required by the treatment and for the proper use of the medicinal product; 3° A reminder of the patient’s rights with regard to the programme, including the prior information to be provided to the patient and the form for…
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.
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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