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Showing 4881–4890 of 18228 articles for “Art. 5° ter”
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…
…f the Agence nationale de sécurité du médicament et des produits de santé of any change likely to alter the conditions under which authorisation has been granted.
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…
…gence nationale de sécurité du médicament et des produits de santé; quality control is said to be internal, if it is carried out by the operator or under his responsibility by a service provider; it i…
…vice and, where applicable, the care establishment concerned to be identified, as well as the characteristics indicated in the medical prescription. This documentation also includes a statement indica…
…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 observations. This decision specifies the con…
…ssessment, the approved body will ensure that the file includes in particular : - the general characteristics of the applicant, such as company name, name, address, legal status ; - a precise descript…
…ve been published in the Journal officiel de la République française, are presumed to meet these criteria.
When the acquisition, possession and supply of veterinary medicinal products by the groups provided for in the first paragraph of article L. 5143-6 are carried out under the supervision of a pharmacis…
In each region, regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
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