Article 919-113
…of national framework scheme no. SA.62102 authorised by the European Commission by decisions of 16 March 2021 C(2021) 1902, 9 December 2020 C(2020) 9072, 20 May 2020 C(2020) 3460 and 25 May 2020 C(20…
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Showing 2191–2200 of 6154 articles for “Art. 13 Mar 2020”
…of national framework scheme no. SA.62102 authorised by the European Commission by decisions of 16 March 2021 C(2021) 1902, 9 December 2020 C(2020) 9072, 20 May 2020 C(2020) 3460 and 25 May 2020 C(20…
…o. SA.100959 authorised by the European Commission by decisions of 20 December 2021 C(2021)9880, 16 March 2021 C(2021) 1902, 9 December 2020 C(2020) 9072, 20 May 2020 C(2020) 3460 and 25 May 2020 C(20…
…es referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Article L. 5121-8, or at the request of the competent nationa…
…rry out vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
…to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004. The draft protocol is submitted solely to the Director General of the Agence nationale d…
…patients or healthcare professionals. These studies are carried out under the responsibility of the marketing authorisation holder referred to in article L. 5121-8, who is responsible for their manage…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
…ght-hand column of the same table: Applicable Provisions As amended byArticle D. 411-1-3 Decree no. 2020-119 of 12 February 2020Article D. 411-19-2 Decree no. 2020-225 of 6 March 2020 Articles D. 412-…
Before administering the punctually prepared advanced therapy medicinal product, the health professional in the health establishment must ensure that the information required for the traceability of t…
The regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-de…
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