Article R5121-163
As part of the pharmacovigilance system, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medi…
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Showing 2411–2420 of 51196 articles for “Art. Cass. 3ème civ. 16-2-2022 n° 20-15.164 FS-B”
As part of the pharmacovigilance system, any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 : 1° Implements a risk management system for each medi…
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…
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 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…
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…
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…
I.-Where an intermediary is subject to a reporting obligation similar to that provided for in Article 1649 AD in several European Union Member States, the cross-border scheme is declared exclusively t…
In order to support the production of new cinematographic works, sums are entered in the automatic cinema production account of delegated production companies for the production of at least one featur…
The centre may be consulted either directly by the pregnant woman or the couple where a proven risk has been identified in application of III of article L. 2131-1, or by the attending physician who se…
The screening and treatment activities referred to in article R. 2311-14 are subject to the supervision provided for in 4° of article R. 1421-6. The medical supervision defined in article L. 315-1 of…
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