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Showing 9341–9350 of 26790 articles for “Art. CE 5-6-2020 n° 423066”
…2° Identification of the medicinal product to be tested: a) Its name or code name ; b) Its pharmaceutical form; c) Its qualitative and quantitative composition in active substances using the common…
…le R. 5141-30 shall make the study protocol and report available to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
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…
…2-1 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. 5142-3 applicable to these activities, sets ou…
…edingstuffs 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. 5142-55 ensures…
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…
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…
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…
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