Article R5121-172
For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are car…
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Showing 2311–2320 of 6154 articles for “Art. 13 Mar 2020”
For the medicinal products mentioned in 1° of II of article L. 5121-12 and in II of article L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are car…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
…on of Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.
…he drug dependence and addictovigilance assessment and information centres mentioned in Article R. 5132-112 are responded to fully and promptly;7° Provide the Director General of the Agence nationale…
…1-6 shall send the Director General of the Agency, annually and immediately on request, a report summarising the information relating to the adverse reactions that he has declared or that have been re…
…ationale de sécurité du médicament et des produits de santé that it has taken action to suspend the marketing of a medicinal product or a product or to withdraw it from the market, or to withdraw a pa…
…97 is required to submit a periodic safety update report: 1° Under the conditions determined by the marketing authorisation or registration; 2° At the request of the Director General of the Agence nat…
…in Article 107g(1) of Directive 2001/83/EC of the European Parliament and of the Council, that the marketing authorisation should be varied, the marketing authorisation holder shall submit to the Dir…
…this medicinal product or product, including the results of studies which may have an impact on the marketing authorisation; 2° A scientific evaluation of the risk-benefit balance of the medicinal pro…
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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