Part five: Health products

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…

When a prosecution is brought by the judicial authority pursuant to the articles of this chapter, the representative of the State in the département may, if the interests of public hygiene or animal health so require, order the temporary closure of the establishment. Natural persons guilty of an offence under this chapter shall be liable to the additional penalty of temporary or permanent closure of the establishment.

Natural persons guilty of the offences provided for in article L. 5441-8 are also liable to the following additional penalties: 1° Posting of the decision and its dissemination, under the conditions set out in article 131-35 of the French Penal Code; 2° Confiscation of the thing that was used or intended to be used to commit the offence or of the proceeds of the sale of this thing, under the…

Legal entities held criminally liable, under the conditions laid down inArticle 121-2 of the French Penal Code, for the offences defined in Article L. 5441-8 shall be liable, in addition to a fine in accordance with the procedures laid down in Article 131-38 of the French Penal Code: 1° (Repealed) ; 2° Posting the decision or broadcasting it either in the written press or by any means of audiovisual communication…