Article R5121-109
…isation is required for each import operation. For medicinal products other than finished products, and for medicinal products necessary for carrying out research involving the human person declared u…
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Showing 8761–8770 of 66752 articles for “Art. 480 al. 1 and Art. 445”
…isation is required for each import operation. For medicinal products other than finished products, and for medicinal products necessary for carrying out research involving the human person declared u…
…al transport, they are exempt from import authorisation under the conditions set out in article L. 5124-13. A sports team doctor who personally transports a medicinal product or who imports a medicina…
…sation period. Renewal of the authorisation is granted under the conditions set out in Articles R. 5121-116 and R. 5121-123. If the Director General of the Agence nationale de sécurité du médicament e…
The certificates referred to in Article L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three…
…ons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an authorised company within the meaning of Ar…
For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time o…
The declaration provided for in the fourth paragraph of Article L. 5124-11 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of providing a…
The application must be accompanied by : 1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sé…
…rietary medicinal product which has already obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the pr…
…y medicinal product which has obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsible for changing the packaging,…
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