Title III: Other regulated pharmaceutical products and substances

The activities of manufacturing, importing and distributing active substances, including with a view to export, may only be carried out in establishments authorised by the National Agency for the Safety of Medicines and Health Products, whether these substances are used in the manufacture of medicinal products for human use or in the manufacture of veterinary medicinal products in accordance with Articles 93 and 95 of Regulation (EU) 2019/6 of 11…

I.-“Raw materials for pharmaceutical use” means all the constituents of medicinal products within the meaning of Article L. 5111-1, i.e. : 1° The active substance or substances. An active substance is any substance or mixture of substances intended to be used for the manufacture of a medicinal product and which, when used for its production, becomes an active component of this medicinal product exerting a pharmacological, immunological or metabolic action…

Raw materials for pharmaceutical use comply with pharmacopoeia specifications where these exist. Active substances used as starting materials in medicinal products for human use are manufactured and distributed in accordance with good manufacturing practice, the principles of which are defined by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Active substances used as starting materials in veterinary medicinal products shall be manufactured…

For the manufacture of medicinal products for veterinary use, the pharmaceutical establishments mentioned in article L. 5142-1, veterinarians, dispensing pharmacies and persons authorised to prepare self-vaccines for veterinary use as well as persons authorised to prepare veterinary medicinal products mentioned in article L. 5142-1-2 use, as starting materials for pharmaceutical use, active substances which meet the requirements of the second paragraph of article L. 5138-3.

When, as part of its inspection powers, the Agence nationale de sécurité du médicament et des produits de santé finds that the manufacture or repackaging and relabelling for distribution of raw materials for pharmaceutical use complies with the good practices provided for in Article L. 5138-3, it issues a certificate of compliance, except for the distribution of excipients. Any establishment carrying out one of the activities mentioned in the first…

Active substances may only be imported from third countries if they have been manufactured in accordance with standards of good practice at least equivalent to those laid down by the European Union, and if they are accompanied by documents defined by regulation attesting in particular to compliance with such standards.

Falsified raw material for pharmaceutical use means any active substance or any excipient, the pharmaceutical use of which is established, which is misrepresented as to its identity, including its packaging and labelling, its name or composition, its origin, including its manufacturer, its country of manufacture, or its history, including authorisations, declarations and documents relating to the distribution channels used.