Article R5121-168
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
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Showing 2891–2900 of 60457 articles for “Art. Art. 200 A”
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
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…
For sums registered on the automatic account or on the automatic accounts grouped into circuits opened in respect of cinematographic entertainment establishments which were due to expire on 31 Decembe…
Taxpayers who have benefited from the tax credit provided for in article 200 quater in contravention of the provisions of c of 6 ter of the same article 200 quater shall be liable for a fine equal to…
The administrative authority may, pursuant to 2° of Article L. 615-1, decide to implement an enforceable expulsion decision taken by one of the other Member States of the European Union, the Republic…
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