Article R5127-5
A sample shall give rise, on the spot, to the drafting of : - as part of an inspection carried out under the conditions laid down in articles L. 1421-1 to L. 1421-3, article L. 5127-2 or article L. 53…
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Showing 7961–7970 of 23627 articles for “Art. CA Paris 9-5-2003”
A sample shall give rise, on the spot, to the drafting of : - as part of an inspection carried out under the conditions laid down in articles L. 1421-1 to L. 1421-3, article L. 5127-2 or article L. 53…
…s narcotics or subject to narcotics regulations, are written on a prescription that meets the technical specifications laid down, after obtaining the opinion of the Director General of the Agence nati…
…umer affairs, industry and health, which allows the competent authorities to monitor the operations carried out. These records indicate the name and quantity of the substances or preparations transfer…
…t subject to compulsory prescription may be administered to day and boarding pupils in secondary education establishments, in application of the provisions of the second paragraph of I of article L. 5…
…he rules laid down in this chapter, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall notify the manufacturer, importer or distributor, informing it…
When the inspection reveals that the manufacture or repackaging and relabelling carried out in the context of the distribution of a raw material for pharmaceutical use does not comply with the good pr…
The application for authorisation is deemed to be complete if, within 30 days of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not inform…
…41-3 with the following information: 1° The title and objective of the trial requested ; 2° Identification of the medicinal product to be tested: a) Its name or code name ; b) Its pharmaceutical form;…
The marketing authorisation holder responsible for the study referred to in Article R. 5141-30 shall make the study protocol and report available to the Director General of the Agence nationale de séc…
Authorisation to open a veterinary pharmaceutical establishment is granted to the company to which it belongs by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, d…
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