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Showing 23112320 of 6154 articles for Art. 13 Mar 2020

French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-162

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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-166

…on of Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004.

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-164

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-174

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-165

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-170

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-171

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-168

…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…

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French Public Health CodeIn force
Paragraph 4: Companies or organisations exploiting a medicinal product or a product mentioned in Article R. 5121-150

Article R5121-169

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…

AI translation · Updated 2 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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