Chapter VIII: Raw materials for pharmaceutical use.

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.