Book I: Pharmaceutical products

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…

In establishments manufacturing medicated feed, the pharmacist or veterinarian in charge or, where applicable, the pharmacist or veterinarian referred to in Article R. 5142-54 ensures that : 1° Only medicated premixes covered by a marketing authorisation or a temporary authorisation for use are used, in accordance with the conditions described in this authorisation; 2° The medicated feed is manufactured from only one medicated premix, with the exception of medicated feeds…

When medicated feedingstuffs are manufactured for the purposes of a clinical trial, they are manufactured in accordance with the sponsor’s instructions. The person responsible referred to in article R. 5142-55 ensures that the medicated feedingstuffs manufactured in this way are used exclusively within the framework of the clinical trial carried out under the conditions provided for in article R. 5141-7.

In establishments authorised to manufacture and import medicated feed, the following information is recorded: 1° The date of manufacture, import, transfer or issue as appropriate and, if manufacture has been subcontracted, the date of the manufacturing order and the date of receipt of the batch; 2° The name, quantity and batch number of the medicinal premix or premixes used; 3° The nature and quantity of the feed used; 4° The…

In establishments authorised to distribute medicated feed, the following information is recorded: 1° The date of acquisition, transfer or issue ; 2° The trade name or, failing that, the nature and quantity of the medicated feed acquired and transferred; 3° The batch number of the medicated feed and the expiry date; 4° The name and address of the manufacturer or distributor supplying the medicated feed; 5° The name and address…

The information referred to in articles R. 5142-57 and R. 5142-58 is, immediately after each operation, recorded by an appropriate system allowing immediate printing at the request of the control authorities and not allowing any modification of the data after validation of their recording. The registers, records and paper copies of these records for periods of no more than one month are kept for a period of five years and…

The provisions relating to full-time practice and replacement contained in articles R. 5142-20 and R. 5142-22 to R. 5142-30 do not apply to the pharmacist or veterinarian mentioned in article R. 5142-54. However, in the event of absence or impediment, the company shall provide for the replacement of the pharmacist or veterinarian by a pharmacist or veterinarian bound by agreement with the company in this capacity. In the event of…

The necessary measures are taken to prevent contamination of other food categories by medicated feed and contamination of medicated feed during manufacture, import, distribution or transport.

Medicated premixes and medicated feeds are stored in locked premises or in hermetically sealed containers separated by category and specially designed for the conservation of these products.

When medicated feed is supplied to a distributor or breeder in closed packaging or containers, the way in which the packaging or containers are closed prevents them from being reused after opening.