Article R5121-164
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…
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Showing 10561–10570 of 36632 articles for “Art. al. 5”
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 Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
…ication of these articles, the authorisation for these preparations is that mentioned in article R. 5121-207.
…y referred to in Article L. 4211-9-1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring the traceability of advance…
Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma i…
The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 is required to: 1° Record all adverse reactions suspected of being due to a medicinal product o…
…suspend or remove the registration of a medicinal product from the list provided for in article R. 5121-202 if the conditions laid down in this article are no longer met or for any public health reas…
…s and cells mentioned in Article R. 1211-19 and in the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq, as…
…e pharmacy which hold blood-derived medicinal products under the conditions mentioned in article L. 5126-6, the supply of blood-derived medicinal products gives rise to the recording by the correspond…
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