Chapter VIII: Raw materials for pharmaceutical use.

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 with a view to restoring, correcting or modifying physiological functions, or establishing a medical diagnosis;

2° The excipient(s). An excipient is any component of a medicinal product other than an active substance and packaging materials.

II - Pharmaceutical use is presumed for these materials when they are sold to :

1° A pharmaceutical establishment mentioned in article L. 5124-1 or article L. 5142-1 ;

2° A pharmacy for internal use ;

3° A pharmacy ;

4° A doctor, a veterinarian or a person authorised to prepare self-vaccines for veterinary use mentioned in article L. 5142-1-1 or veterinary medicinal products mentioned in article L. 5142-1-2 ;

5° An establishment or organisation mentioned in article L. 5142-1-1 or article L. 5142-1-2.

This is not the case when the person selling these materials provides proof of a different use by producing a certificate from the purchaser.

III - In order to establish, or not, the pharmaceutical use of one of the raw materials mentioned in I and sold to a person other than those listed in II, the seller must be able to justify the use of these raw materials. To this end, he may ask the purchaser for a certificate attesting to their intended use.

IV -The manufacture of a raw material for pharmaceutical use means the complete or partial manufacture of this raw material as well as the various processes of division or packaging prior to its incorporation into a medicinal product and storage, with a view to its sale.

V.-Distribution of a raw material for pharmaceutical use means the activities of purchasing, selling, repackaging, relabelling and storage.