Article R5121-117
…lready obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the proprietary medicinal product which has…
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Showing 4731–4740 of 59873 articles for “Art. s. 1844-10-1 to 1844-17”
…lready obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the proprietary medicinal product which has…
…t of the proprietary medicinal product benefiting from a parallel import authorisation is identical to that of the proprietary medicinal product which has obtained marketing authorisation in France, e…
The application for parallel import authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate n…
…a sample of the proprietary medicinal product marketed in the country of origin, which is intended to be imported into France; 2° A copy of the authorisation to open the establishment authorised with…
The provisions of this section apply to the import and export of : 1° Medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products…
…roduits de santé of any changes of which it is aware concerning the marketing authorisation granted to the medicinal product in the country of origin. Where appropriate, it will take the necessary mea…
…ter it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medici…
The application for an import authorisation must be sent by any means capable of providing a date certain and must indicate : 1° The name or business name and address of the natural or legal person re…
…of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained marketing authorisation in France,…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application a…
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