Title IV: Veterinary medicinal products

Carrying out the non-clinical trials mentioned in article L. 5141-4 without complying with the good laboratory practice mentioned in the same article is punishable by a fine of 3,750 euros.

Failure by a sponsor to provide investigators with the information required by law relating to veterinary medicinal products undergoing experimentation or trials is punishable by two years’ imprisonment and a fine of €30,000.

Failure by a sponsor, either within the two-month period preceding the clinical trial or when a substantial amendment to the trial is made, to send the Agency the information required by law relating to the testing of medicinal products is punishable by two years’ imprisonment and a fine of 30,000 euros. The same penalties will apply if a sponsor fails to comply with the Agency’s decision to oppose the implementation…

The following are punishable by two years’ imprisonment and a fine of €150,000: 1° Failure by the holder of a manufacturing authorisation to have a qualified person in accordance with Article 97 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products; 2° Failure by the holder of a wholesale distribution authorisation to have a person responsible for wholesale distribution…

Opening or operating an establishment defined in Article L. 5142-1, without the authorisation required pursuant to Articles 88 and 99 of Regulation (EU) 2019/6 of 11 December 2018 or without this having been renewed in the event of a change to the elements included in the initial authorisation, is punishable by two years’ imprisonment and a fine of €150,000.

The supply to the public by the legal representative of an establishment mentioned in article L. 5142-1 of the veterinary medicinal products mentioned in article L. 5141-2 is punishable by two years’ imprisonment and a fine of €30,000.

Manufacturers, importers and holders of veterinary medicinal products who fail to declare their production, import or stock at the express request of the authorities in the event of an epizootic disease outbreak are liable to a fine of €30,000.

I.-The following is punishable by five years’ imprisonment and a fine of 375,000 euros: 1° Placing on the market, free of charge or for consideration, a veterinary medicinal product subject to the provisions of Articles 5 and 86 of Regulation (EU) 2019/6 of 11 December 2018 and Articles L. 5141-9 or L. 5141-10 without first obtaining the marketing authorisation, registration or temporary authorisation for use provided for in these articles;…

The following is punishable by two years’ imprisonment and a fine of 150,000 euros: 1° The fact, for the qualified person mentioned in II of Article L. 5142-1, of releasing a batch of veterinary medicinal products that have not been manufactured in accordance with the good manufacturing practices mentioned in Article 93 of Regulation (EU) 2019/6 of 11 December 2018 and, until the adoption of the implementing acts mentioned by…

The following are punishable by two years’ imprisonment and a fine of €30,000: 1° Failure to prepare self-vaccines in compliance with the obligations set out in Article L. 5142-1-1; 2° Failure to comply with the conditions for prescribing self-vaccines and their use set out in point 5 of Article 106 of Regulation (EU) 2019/6 of 11 December 2018; 3° Failure to declare changes to the constituent elements of the declaration…