Book IV: Criminal and financial penalties

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in addition to a fine in accordance with the procedures laid down in Article 131-38 of the French Penal Code: 1° (Repealed) ; 2° Posting the decision or broadcasting it either in the written press or by any means of audiovisual communication…

Granting exclusive rights to sell veterinary medicinal products to one or more categories of reseller is punishable by a fine of €3,750.

The failure of a qualified person of a veterinary medicinal product manufacturing establishment referred to in Article 97 of Regulation (EU) 2019/6 of 11 December 2018 or of a person responsible for a wholesale distribution establishment referred to in Article 101 of the same Regulation to declare to the Agency, when they become aware of it, after the marketing of a batch of veterinary medicinal product, of an incident or…

Failure by the marketing authorisation or registration holder to report to the pharmacovigilance database referred to in Article 74 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC any suspected adverse reaction, in accordance with Article 76(2) of the same Regulation, shall be punishable by two years’ imprisonment and a fine of €30,000.

Failure to comply with an order to suspend, modify or withdraw an authorisation issued by the Agency pursuant to articles L. 5145-3 and L. 5145-4 is punishable by two years’ imprisonment and a fine of €30,000.