Part five: Health products

Any manufacturer, importer or distributor of excipients as defined by Article L. 5138-2 who carries out his activity without having declared himself to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) pursuant to and in accordance with the conditions laid down by Article L. 5138-1 shall be liable to the fine laid down for fifth-class…

Using the certificate of conformity referred to in article L. 5138-4 when its validity has been terminated in application of article R. 5138-5 is punishable by a 5th class fine.

Failure by the manufacturer, importer or distributor of a raw material for pharmaceutical use to communicate to the Agence nationale de sécurité du médicament et des produits de santé any changes to the information or particulars contained in the documents requested for authorisation or in the declaration or descriptive dossier provided for in Article L. 5138-1, in accordance with the conditions laid down in Articles R. 5138-1 and R. 5138-2,…

Repeated offences under articles R. 5438-1 and R. 5438-2 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.

The following is punishable by the fine laid down for fifth class offences: 1° For the pharmacist or veterinarian in charge of a company mentioned in 1° to 10° of article R. 5142-1 or for a pharmacist or veterinarian delegate, to combine this activity in breach of the provisions of article R. 5142-31 ; 2° For the pharmacist or veterinary surgeon in charge of a company mentioned in 1° to…

Natural persons guilty of the offences defined in article R. 5441-1 are also liable to the additional penalty of confiscation of the veterinary medicinal product which was used or intended for use in committing the offence.

Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Penal Code, for the offences defined in article R. 5441-1 are liable, in addition to a fine in accordance with the procedures set out in article 131-41 of the French Penal Code, to the confiscation of the veterinary medicinal product which was used or intended to be used to commit the offences set out…

Repeated offences under article R. 5441-1 are punishable in accordance with articles 132-11 and 132-15 of the French Penal Code.