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Showing 2481–2490 of 62342 articles for “Art. R 315-26 and Art. R 315-30 s.”
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…
Renewal is granted or refused following a procedure identical to that followed for an initial application for approval. An organisation which has not submitted the annual report referred to in Article…
In application of article L. 1221-3, any public or private body, of any nature whatsoever, wishing to provide training for local elected representatives provided for in articles L. 2123-12, L. 3123-10…
In the absence of an application for renewal, approval lapses on expiry of the two- or four-year period for which it was issued..
Accreditation is renewable for four-year periods.
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