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Showing 9531–9540 of 61834 articles for “Art. R 581-36 and R 581-37”
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…
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…
The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this au…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
The authorisation to open, provided for in the first paragraph of Article L. 5124-3, a pharmaceutical establishment, a company or a body mentioned in Article R. 5124-2 is issued by the Director Genera…
The closure of a pharmaceutical 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…
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, wh…
The provisions of this chapter apply to the companies, bodies and public establishments mentioned in articles L. 1413-1, L. 5124-2, L. 5124-7, L. 5124-8, L. 5124-9-1 as well as to their pharmaceutical…
The following definitions apply1° Manufacturer means the company or organisation engaged in the manufacture of medicinal products, products or articles referred to in article L. 4211-1 , with a view t…
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, di…
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