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Showing 6311–6320 of 66237 articles for “Art. III and IV”
…4-3 or, for establishments or organisations manufacturing products referred to in article L. 1243-1 and in 12° and 13° of article L. 5121-1, the authorisation referred to in articles L. 1243-2, L. 421…
The manufacture, import, export and wholesale distribution of medicinal products, products and articles mentioned in article L. 4211-1, the manufacture, import and distribution of investigational medi…
The opening of a pharmaceutical establishment, whatever its activity, is subject to an authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. This authorisati…
I.-The provisions of articles L. 5124-1 and L. 5124-2, with the exception of the provisions of the first paragraph of this article, apply to the medical supply establishments of the armed forces healt…
An on-call system is organised to meet urgent requirements for medicinal products outside the opening days generally used by wholesaler-distributors in their territory of distribution. All the wholesa…
In the case of research involving the human person relating to the gene therapy and xenogenic cell therapy preparations mentioned in 12° and 13° of Article L. 5121-1, the authorisation to conduct the…
…the armed forces health service may, in order to meet specific defence requirements, import, export and distribute, after obtaining the opinion of the Agence nationale de sécurité du médicament et des…
…er to cover the needs of patients in their area of distribution. They participate in the prevention and management of drug shortages, as part of the public service obligations mentioned in the first p…
The medicinal products mentioned in II and III of article L. 5124-8 are manufactured in accordance with the good practices provided for in article L. 5138-3, subject to adaptations made necessary by s…
Notwithstanding the provisions of Article L. 4211-1 and those of the first paragraph of Article L. 5124-2, Institut Pasteur remains authorised to ensure, in accordance with its statutes, the preparati…
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