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Showing 5391–5400 of 20314 articles for “Art. CAA Paris 28-5-2013 n° 12PA03642”
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…
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…
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…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the conditions for applying th…
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture,…
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