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Showing 4671–4680 of 17962 articles for “Art. 5 avr. 2011”
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…
…for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49 apply subject to the following modifications: 1° For class II a medical devices, the authori…
…24 September 2013 on the designation and monitoring of bodies notified under Council Directive 90/385/EEC concerning active implantable medical devices and Council Directive 93/42/EEC concerning medic…
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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