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Showing 5811–5820 of 21091 articles for “Art. CA Paris 20-5-2009 n° 08-2432”
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…
…r 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 the procedures defined in Art…
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,…
…tation is suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after the head of the body has been asked to present his observatio…
Before examining the application for assessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, addres…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall decide on the application within seven months of the date of receipt of the complete file. Failing…
…inary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacist who actually participates in the technical managem…
In each region, regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out his duties relating…
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