Article R5124-5
…nitial authorisations and for transfer of authorisations to open, as provided for in Articles R. 5124-6, R. 5124-7, R. 5124-10, R. 5124-10-1, R. 5124-10-2, R. 5124-13 and R. 5124-14 , as well as the c…
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Showing 11861–11870 of 38939 articles for “Art. al. 4”
…nitial authorisations and for transfer of authorisations to open, as provided for in Articles R. 5124-6, R. 5124-7, R. 5124-10, R. 5124-10-1, R. 5124-10-2, R. 5124-13 and R. 5124-14 , as well as the c…
A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dos…
The formalities of transcribing, recording and drawing up the forms provided for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.
…duct; 3° Suggest that a normal state of health can be improved by the use of the medicinal product; 4° Suggest that a normal state of health may be affected if the medicinal product is not used; this…
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé…
…submit the declarations and reports mentioned in Articles R. 5121-166, R. 5121-168 and R. 5121-170; 4° Ensuring the implementation and monitoring of post-authorisation safety studies as well as the sp…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or remove the registration of a medicinal product from the list provided for in article R. 5…
…es and cells mentioned in Article R. 1211-19 and in the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq, a…
Without prejudice to the obligations laid down in Articles R. 5121-138 to R. 5121-142, the packaging of a blood-derived medicinal product includes three detachable labels, separate from the informatio…
…170 ; 3° Information transmitted by the regional pharmacovigilance centres mentioned in Article R. 1413-61-4;4° Reports sent in application of article R. 5121-175 by pharmaceutical establishments, inc…
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