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Showing 3351–3360 of 13796 articles for “Art. European Commission report COM”
…up at the request of the Agence nationale de sécurité du médicament et des produits de santé or the European Commission, in particular as part of the risk management plans provided for either in 3° of…
…du médicament et des produits de santé will give his opinion within three months of receipt of the complete application by his departments. If no response is received within this period, the authoris…
…é by any means which allows this application to be dated with certainty. II. - The application is accompanied by a dossier which includes : 1° The precise designation of the product ; 2° Where applica…
In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the cas…
…ion of the second paragraph of II and III of article L. 1245-5 shall mention in the annual activity report provided for in article R. 1243-22 the types and quantities of tissues and cells imported as…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised legal entities or individuals, giving their names and addresses a…
…be dated, by an establishment or body already authorised under Article L. 1243-2. This request is accompanied by a letter from the applicant justifying the need to import elements or products from the…
Any modification of the information contained in the initial import and export authorisation application dossier, concerning the nature or origin of the products, as well as the substantial modificati…
I. - Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell thera…
…ion to export tissues and cells from a supplier established in a State which is not a member of the European Union or a party to the Agreement on the European Economic Area, as well as any other decis…
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