Chapter II: Industrial preparation and wholesale.

I.-The manufacture, import, export and wholesale distribution of veterinary medicinal products, and the manufacture, import and distribution of medicinal products subject to clinical trials, are carried out by establishments governed by Regulation (EU) 2019/6 of 11 December 2018 and by this chapter. II.-In each establishment authorised under Article 88 of Regulation (EU) 2019/6 of 11 December 2018, a qualified person is responsible in particular for carrying out the tasks specified…

The manufacture of autovaccines for veterinary use referred to in paragraph 3 of Article 2 of Regulation (EU) 2019/6 of 11 December 2018 is carried out by a qualified person or a company or body employing a qualified person who has obtained an authorisation for this purpose issued by the National Agency for Food, Environmental and Occupational Health Safety. This activity is subject to pharmacovigilance obligations, the content of which…

The preparation of veterinary medicinal products not falling within the scope of Regulation (EU) 2019/6 of 11 December 2018, excluding extemporaneous preparations, is carried out by a qualified person or a company or body employing a qualified person who has obtained an authorisation for this purpose issued by the National Agency for Food, Environmental and Occupational Health Safety. This activity is subject to pharmacovigilance obligations, the content of which is…

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.

The local or regional representative referred to in paragraph 3 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall carry out his duties in professional premises located on national territory. His activity shall be subject to a declaration to the Director General of the National Agency for Food, Environmental and Occupational Health Safety.

I.-A marketing authorisation holder who does not himself carry out the advertising operations referred to in Articles 119 and 120 of Regulation (EU) 2019/6 of 11 December 2018 shall declare to the Director General of the National Agency for Food, Environmental and Occupational Health Safety the name of the person to whom he has entrusted these operations on the national territory, his contact details and the address of his business…

The opening of an establishment referred to in Article L. 5142-1 is subject to an authorisation issued by the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail. This authorisation may, after formal notice, be modified, suspended or withdrawn in the event of failure to comply with or infringement of Regulation (EU) 2019/6 of 11 December 2018 or the provisions of Book II of Part…

The establishments mentioned in Article L. 5142-1 are not authorised to supply the public with the veterinary medicinal products defined in Article L. 5141-2. However, these establishments may sell veterinary medicinal products intended for the manufacture of medicated animal feed and intermediate products approved under Regulation (EU) 2019/4 of 11 December 2018 to manufacturers of medicated animal feed and intermediate products. The Minister for Agriculture may acquire directly from these…

If the availability of veterinary medicinal products is insufficient to meet the requirements of the fight against an epizootic disease, the Minister for Agriculture may, with a view to ensuring that these medicinal products are distributed according to national needs, require manufacturers, importers and holders of these medicinal products to declare all of their production, imports and stocks.

Advertising concerning the establishments mentioned in article L. 5142-1 is only authorised under certain conditions laid down by regulation.