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 3491–3500 of 66039 articles for “Art. R 581-52-1 to R 581-52-4”
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…
When the penal composition has been validated or, in the case provided for by article R. 15-33-40-1, where the proposed measures have been accepted, the public prosecutor may appoint a delegate or med…
Commission members are entitled to reimbursement of their travel expenses.
Each full member appointed under 1° of article R. 1115-9 has an alternate appointed under the same conditions. Alternate members may only attend meetings and take part in votes if the full member they…
The commission collects, from local and regional authorities and their groupings, and updates information relating to actions that fall within the scope of the external action of local and regional au…
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