Article R5139-5
…ationale de sécurité du médicament et des produits de santé has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents. If the…
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Showing 4871–4880 of 18228 articles for “Art. 5° ter”
…ationale de sécurité du médicament et des produits de santé has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents. If the…
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…
…the depository and the operator on whose behalf it is acting. They may only distribute batches of veterinary medicinal products which have been released by the pharmacist or veterinarian responsible f…
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…
…ty procedure, product quality assurance, only applies to medical devices placed on the market in a sterile state or with a measuring function and, depending on the case, only covers aspects relating t…
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