Subsection 9: Establishments manufacturing, importing or distributing medicated feed.

Where the last paragraph of

Article L. 5142-1

is applied, in the establishments of the companies mentioned in 11°, 12°, 13° and 14° of Article R. 5142-1, the pharmacist or veterinarian responsible for applying the legislative and regulatory provisions relating to medicated feedingstuffs is bound by an agreement with the company concerned and has at least the following duties:

1° Responsible for the quality of medicated feedingstuffs manufactured, imported or distributed by the establishments concerned;

2° He organises and controls the manufacturing, import or distribution activities mentioned in

article R. 5142-1

in compliance with the good practices applicable to these activities and liaises with the person mentioned in article R. 5141-108 responsible for veterinary pharmacovigilance within the companies operating the medicated premixes used, as well as with the pharmacist or veterinarian responsible for these companies with regard to their advertising;

3° It checks the registers or records provided for in Articles R. 5142-57 to R. 5142-59 ;

4° It checks compliance with the conditions of supply set out in article L. 5142-4 ;

5° It organises an emergency plan for the withdrawal of batches of medicated feed;

6° It proposes any improvement measures it deems useful to ensure the implementation of good practices.

In order to carry out these duties, the pharmacist or veterinarian makes regular visits, the frequency of which is adapted to the nature and importance of the operations concerning medicated feedingstuffs and is set by the good practices applicable to this activity. The pharmacist or veterinarian records the dates of his visits and his observations by means of an appropriate system allowing immediate publication at the request of the control authorities and not allowing any modification of the data after validation of their recording.

The pharmacist or veterinarian shall inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the agents mentioned in Article R. 5146-1 responsible for inspecting the establishment of any difficulties encountered in carrying out their duties and of any observations they may make in the interests of public health.