The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised legal entities or individuals, giving their names and addresses and the category of products that each of them is authorised to import or export. This list is accessible to the public.
The application for authorisation provided for in III of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2, accompanied by a letter from the applicant justifying the need to import or export as a matter of…
The application for authorisation provided for in the second paragraph of II of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2. This request is accompanied by a letter from the applicant justifying the need to…
Establishments or organisations authorised to carry out imports in application of the second paragraph of II and III of article L. 1245-5 shall mention in the annual activity report provided for in article R. 1243-22 the types and quantities of tissues and cells imported as well as their origin and destination.
I. – The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European Economic Area that do not have the authorisation provided for in Article 6(2) of Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human…
I. – The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within three months of the date on which the application is deemed to be complete. II. – He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated…
Pursuant to the fourth paragraph of the I of Article L. 1245-5, when the elements or products mentioned in Article R. 1245-1 do not benefit from the authorisation mentioned in Article L. 1243-2, establishments or organisations planning to supply these elements or products to a Member State of the European Union or party to the Agreement on the European Economic Area must send the Agence nationale de sécurité du médicament…
The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application of the last paragraph of I of Article L. 1245-5, the Director General of the Agence nationale de sécurité du médicament et des produits de santé is considering prohibiting the departure from national territory of an…
The provisions of Section 4 of Chapter V of Title III of this Book are applicable to the entry into and exit from national territory from or to a Member State of the European Union or party to the Agreement on the European Economic Area, to the import and export of tissues, their derivatives and cells of the human body defined in Article R. 1245-1 for scientific purposes.
Manufacturers of in vitro diagnostic medical devices may import or export tissues, their derivatives and cells from the human body, whatever their level of processing, when these products are intended for the manufacture of in vitro diagnostic medical devices meeting the requirements to which they are subject for their marketing. The manufacturers concerned must declare their import activity to the Director General of the Agence nationale de sécurité du médicament…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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