Article R5138-5
…material for pharmaceutical use does not comply with the good practices provided for in Article L. 5138-3, the inspected establishment shall immediately inform the manufacturers of the medicinal prod…
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Showing 4671–4680 of 17894 articles for “Art. 5 nov. 2003”
…material for pharmaceutical use does not comply with the good practices provided for in Article L. 5138-3, the inspected establishment shall immediately inform the manufacturers of the medicinal prod…
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…
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…
…nal products concerned. The authorisation to open specifies the activity provided for in article R. 5142-1 for which it is granted. For the same establishment, the authorisation may mention several ac…
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 depositories defined in 4° of article R. 5142-1 carry out their activities under the conditions set out in a written contract which, in accordance with the good practices provided for in article L…
…red in accordance with the sponsor's instructions. The person responsible referred to in article R. 5142-55 ensures that the medicated feedingstuffs manufactured in this way are used exclusively withi…
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…
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