Article R5121-169
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
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Showing 1801–1810 of 60371 articles for “Art. R 225-166-1 · ANSA 24-031”
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparati…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluati…
The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a r…
The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité…
I. - Subject to the adaptations provided for in II and III, the provisions of the articles mentioned in the left-hand column of the table below shall apply in French Polynesia, in the wording indicate…
Provided that they have not been deleted under the conditions laid down in Articles R. 53-14-1 to R. 53-14-4, data and information are kept for the maximum periods detailed in the following paragraphs…
Related to the certification procedure provided for in article R. 225: 1° The costs listed in article R. 92 which are subject to a fee structure set by the provisions of Title X of Book V (Decrees in…
The filing provided for in the first paragraph of article R. 123-105 includes for joint-stock companies and non-trading companies formed by public offering: 1° A copy of the minutes of the general mee…
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