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Showing 1157111580 of 38939 articles for Art. al. 4

French Public Health CodeIn force
Paragraph 4: Pharmacovigilance notification and reporting

Article R5141-103

…or human use administered to an animal under the conditions provided for in a of 3° of article L. 5143-4, shall immediately report it to the Agence nationale de sécurité sanitaire de l'alimentation, d…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 8: Advertising.

Article D5141-88-1

I.-The amount of the tax provided for in 5° of 1 of I of article L. 5141-8 is set at : a) €2,000 per request for prior authorisation for advertising relating to a medicinal product and comprising up t…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 10: Special provisions.

Article R5141-123-9-1

…icted the conditions of supply to the exclusive use of veterinarians in application of article R. 5141-41 may not be the subject of a parallel import authorisation by an owner or professional keeper o…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 10: Special provisions.

Article R5141-122-1

Veterinarians alone are authorised to administer, in the cases provided for in Article L. 5143-4, to equidae declared as being intended for slaughter for human consumption, medicinal products for huma…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 1: Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (French National Agency for Food, Environmental and Occupational Health Safety)

Article R5141-96-1

The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall immediately inform the European Medicines Agency and the other Member State…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 8: Advertising.

Article R5141-86-1

…dicinal product reproduces in full the summary of product characteristics mentioned in article R. 5141-15, publications intended to reference veterinary medicinal products are exempt from the authoris…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 7: Sampling and official control of veterinary medicinal products.

Article R5141-81

…s together with the inspection reports approved by the qualified person referred to in Article L. 5142-1. The Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 6: Annual tax

Article D5141-60

The amount of the annual tax provided for in 1°, 2°, 5° and 6° of 1 of II of Article L. 5141-8 is set at 0.45% of the annual turnover, excluding value added tax, generated in France.The amount of tax…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Paragraph 3 : Application for parallel trade authorisation

Article D5141-57

The amount of the fee provided for in 4° of 1 of I of article L. 5141-8 is set at €7,500 per request for authorisation for parallel trade in a veterinary medicinal product.

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 4: Post-authorisation studies

Article R5141-48

…inal products that already have a marketing authorisation" within the meaning of 6° of article L. 5141-16, hereinafter referred to as "post-authorisation studies", means studies carried out under the…

AI translation · Updated 1 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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