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Showing 5211–5220 of 43956 articles for “Art. L. 145-5”
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…
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,…
If an accredited body ceases to fulfil the conditions or fails to meet the obligations mentioned in Article R. 5211-56, accreditation is suspended or withdrawn by the Director General of the Agence na…
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