Article R4211-61
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
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Showing 4041–4050 of 14002 articles for “Art. avis 9 mars 2018”
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
…du médicament et des produits de santé: 1° A new activity, among those mentioned in article L. 4211-9-2 ; 2° The manufacture or import of a new category of investigational advanced therapy medicinal p…
Health establishments authorised under this section which distribute advanced therapy medicinal products must keep at least the following information for each incoming and outgoing transaction: 1° The…
Changes other than those mentioned in articles R. 4211-58 and R. 4211-59 are declared in the annual activity report provided for in article R. 4211-62.
The authorised health care organisation sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Regional Health Agency an…
Health establishments authorised in application of this section may apply for a certificate of compliance with the good practices referred to in Article L. 5121-5. This certificate may be issued by th…
The provisions of articles R. 5124-3-1, with the exception of the last paragraph, R. 5124-4, R. 5124-48, R. 5124-57-1 to R. 5124-57-6 and R. 5124-60 are applicable to health establishments authorised…
The departmental safety and accessibility advisory committee set up under decree no. 95-260 of 8 March 1995 is responsible for giving an opinion, under the conditions set out in the aforementioned dec…
…and column of the same table:Applicable articlesIn the wording resulting from the decreeR. 211-1No. 2018-1226 of 24 December 2018R. 211-2 to R. 211-6no. 2023-421 of 31 May 2023R. 211-7 to R. 211-9n° 2…
…and column of the same table:Applicable articlesIn the wording resulting from the decreeR. 211-1No. 2018-1226 of 24 December 2018R. 211-2 to R. 211-6no. 2023-421 of 31 May 2023R. 211-7 to R. 211-9n° 2…
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