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Showing 6471–6480 of 59300 articles for “Art. 9° and 10°”
…A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intend…
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…
…orisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal product which has obtained the marke…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
…plication 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 responsi…
The labelling and outer packaging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained ma…
…remains silent for a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel impor…
…fused on expiry of a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-111 and R. 5121-112. The time limit mentioned in the pre…
The import authorisation or, for private individuals, a copy of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate…
…e European Economic Area, in which it has obtained a marketing authorisation; 2° Whose quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and th…
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