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Showing 1331–1340 of 30656 articles for “Art. R 221-85”
Any company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovig…
The holder of the authorisation provided for in Article L. 4211-6 is required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé…
The company or organisation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about thi…
By way of derogation from the provisions of Article R. 5121-168, any company or organisation exploiting an authorised or registered medicinal product or product, in accordance with the procedure laid…
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
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…
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