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Showing 2481–2490 of 8951 articles for “Art. 13 March 2001”
…ssessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament and of the Council, that the marketing authorisation should be…
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…
…n Parliament and of the Council or to the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council in order to request the setting of European…
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…
…AMENDED BY R. 4126-5 Decree no. SPRH2219553D of 27 February 2023 R. 4126-6Decree no. 2007-434 of 25 March 2007 R. 4126-7Decree no. 2019-1286 of 3 December 2019 R. 4126-8Decree no. 2019-1286 of 3 Decem…
The employer, the head of the external company or the self-employed worker shall, where appropriate, set up a radiation protection organisation when the nature and extent of the risk of exposure of wo…
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