Article R5121-175
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…
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Showing 5571–5580 of 63727 articles for “Art. s. R 623-7 and R 623-18”
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…
The enforcement measures provided for in Article L. 412-1 the provisions of Articles 2 to 5 and 18 to 20 of Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 200…
Any form of bulk sale is prohibited for the following products: 1° Heat-treated liquid dairy products, in accordance with the provisions of Chapter III of Section IX of Annex III to Regulation (EC) No…
Recognition and enforcement of the judicial supervision order shall be refused in the following cases:1° The certificate is not produced, is incomplete or clearly does not correspond to a judicial sup…
I.-Before 1 January 2023, insurance undertakings may be authorised, under the conditions set out in this article, to transfer all or part of their portfolio of commitments corresponding to :the contra…
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…
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