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Showing 61–70 of 38628 articles for “Art. L 1243-11”
The provisions of this sub-section apply to organisations carrying out the conservation and preparation for scientific purposes of tissues and cells from the human body and their derivatives when thes…
The authorised establishment or body must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé a copy of any instrument appointing the responsible perso…
I. - Substantial changes to the authorisation referred to in Article R. 1243-6 are subject to prior written authorisation by the Director General of the Agence nationale de sécurité du médicament et d…
Authorised establishments or organisations shall make available to the Agence nationale de sécurité du médicament et des produits de santé updated data concerning staff, equipment and any information…
The Minister for Research may at any time suspend or prohibit the pursuit of activities that no longer meet the requirements set out in Article L. 1243-3. When the organisation is a health establishme…
Any change to the information contained in the application for authorisation or renewal of authorisation is immediately brought to the attention of the Minister for Research and, where applicable, the…
In the event of infringement of legislative and regulatory provisions or failure to comply with the requirements mentioned in the second paragraph of Article R. 1243-62, the authorisation may be suspe…
The application for authorisation consists of a letter signed by the legal representative of the applicant organisation and a supporting file, entered via a teleservice. The letter describes the activ…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within four months of the date on which the application is dee…
Applicant establishments or organisations have premises that guarantee the quality and safety of tissues or their derivatives or cell therapy preparations, in accordance with the rules of good practic…
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