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Showing 1056110570 of 36632 articles for Art. al. 5

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

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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 17: Conditions for authorisation of individually prepared advanced therapy medicinal products

Article R5121-216

The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 16: General conditions for authorisation of gene therapy preparations and xenogenic cell therapy preparations

Article R5121-208

…ication of these articles, the authorisation for these preparations is that mentioned in article R. 5121-207.

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 6: Advanced therapy medicinal products prepared on an individual basis

Article R5121-201-5

…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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 3: Reporting obligations.

Article R5121-200

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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 2: Monitoring of blood-derived medicinal products

Article R5121-195

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…

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 R5121-166

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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Section 14: Inclusion on the list of medicinal products for officinal use

Article R5121-204

…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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 6: Advanced therapy medicinal products prepared on an individual basis

Article R5121-201-4

…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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 2: Monitoring of blood-derived medicinal products

Article R5121-191

…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…

AI translation · Updated 2 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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