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Showing 8201–8210 of 69703 articles for “Art. I and II”
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…
Unless expressly stated otherwise in the authorisation to open provided for in Article R. 5124-6, a pharmaceutical establishment benefiting from an authorisation granted under 5° of Article R. 5124-2…
For an authorised establishment, the addition of a new activity within the meaning of Article R. 5124-2 is subject to an application for authorisation examined under the conditions set out in Article…
By way of derogation from the provisions of Article R. 5124-3, manufacturers and importers of medicinal products may only distribute investigational medicinal products and, where applicable, ancillary…
Manufacturers, importers, operators, stockists, wholesaler-distributors, wholesale distributors of pharmaceutical products other than medicinal products, wholesale distributors of medicinal plants, di…
Any change in the holder of an authorisation to open a pharmaceutical establishment is subject to prior authorisation. However, the Director General of the Agence nationale de sécurité du médicament e…
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