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Showing 1881–1890 of 21504 articles for “Art. Cass. com. 12 June 2019”
…e 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 import will be refused. This time limit is ex…
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…
…duct benefiting from the parallel import authorisation complies with the provisions of Articles R. 5121-118, R. 5121-119 and R. 5121-128.
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…
…thorisation in France;-the classification of the product in the categories mentioned in article R. 5121-36.
Pursuant to Article L. 5122-1, an application for an advertising 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. 5…
…rmaceutical establishment belonging to the companies and organisations mentioned in 1° to 3° of R. 5124-2 must be notified to the Agence nationale de sécurité du médicament et des produits de santé no…
A person who fulfils the conditions laid down in the first paragraph of article L. 5125-2 and intends to practise pharmacy concurrently with one of the professions of doctor, dental surgeon, midwife o…
…belonging to one or more of the establishments, services or organisations mentioned in Article R. 5126-1, provided that the quality and safety of the response to the pharmaceutical needs of the peopl…
A decree issued on the report of the Minister of Finance determines the amount and terms of payments to be made by audited bodies to cover the costs incurred in carrying out the audit.
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