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Showing 2971–2980 of 8984 articles for “Art. n° 22-18436 · AFNOR NF K 12-500”
…nd address of the applicant ; 2° Concerning the proprietary medicinal product which has obtained marketing authorisation in France: its name, strength, pharmaceutical form and qualitative and quantita…
…ed by a dossier comprising : 1° 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 cou…
…risation. Except in emergencies, such decisions to suspend or withdraw authorisations may only be taken after the authorisation holder has been given the opportunity to present its observations.
…s time limit is extended by fifteen days if the Director General of the Agency requests additional information from the applicant which may be necessary to examine the application. When the examinatio…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
When the marketing authorisation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité…
For each parallel import operation, the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the author…
…inal product benefiting from a parallel import authorisation is subject to the provisions of the marketing authorisation for the proprietary medicinal product which obtained the marketing authorisatio…
…ng approval for a medicinal product, as provided for in Article L. 5122-9, is made for any form of information, as defined by Article L. 5122-1, communicated to healthcare professionals authorised to…
…establishment of the companies and organisations mentioned in 4° to 15° of R. 5124-2 gives rise to information from the Agence nationale de sécurité du médicament et des produits de santé no later tha…
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