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Article L5142-1-3 of the French Public Health Code

When carrying out their activity on national territory, the qualified person in pharmacovigilance referred to in paragraph 8 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall have professional premises.

Their activity shall be subject to a declaration to the Director General of the National Agency for Food, Environmental and Occupational Health Safety.

Original in French 🇫🇷
Article L5142-1-3

Lorsqu’elle exerce son activité sur le territoire national, la personne qualifiée en pharmacovigilance mentionnée au paragraphe 8 de l’article 77 du règlement (UE) 2019/6 du 11 décembre 2018 possède un local professionnel.

Son activité est subordonnée à une déclaration auprès du directeur général de l’Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail.

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