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Showing 5091–5100 of 43903 articles for “Art. L 227-5”
The sponsor provides the investigators within the meaning of Article R. 5141-3 with the following information: 1° The title and objective of the trial requested ; 2° Identification of the medicinal pr…
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…
The information referred to in articles R. 5142-57 and R. 5142-58 is, immediately after each operation, recorded by an appropriate system allowing immediate printing at the request of the control auth…
When medicated feedingstuffs are manufactured for the purposes of a clinical trial, they are manufactured in accordance with the sponsor's instructions. The person responsible referred to in article R…
A veterinary pharmaceutical establishment mentioned in article R. 5142-1 engaged in the wholesale, free transfer or wholesale distribution of veterinary medicinal products must have an emergency plan…
Any person who sterilizes with a view to placing on the market CE-marked medical devices designed by their manufacturer to be sterilized before use or systems or kits referred to in Section 10 of this…
Within the framework of the EC declaration of conformity procedure, product quality assurance, for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49…
The bodies responsible for carrying out the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation ha…
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