Title III: Other regulated pharmaceutical products and substances

Persons engaged in the manufacture, processing and domestic and international trade of psychotropic substances and their preparations are required to enter in a register or to record by any appropriate system meeting the characteristics laid down in the first paragraph of article R. 5132-9: 1° The nature and quantity of psychotropic substances or their preparations used ; 2° The nature and quantity of the product or products obtained; 3° The…

Apart from cases of transit through or through customs territory, it is prohibited to import or export psychotropic drugs without a special authorisation issued for each operation by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This authorisation is issued under the conditions set out in Article R. 5132-88-1. The authorisation states the name and quantity of the product involved in the…

Manufacturers who manufacture or process psychotropic substances or their preparations draw up an annual summary statement indicating for each psychotropic substance: 1° The quantities manufactured ; 2° Quantities acquired on the national market; 3° Quantities imported; 4° The quantities used for the manufacture of the preparations mentioned in articles R. 5132-44 and R. 5132-2, or the manufacture of non-psychotropic substances; 5° The quantities used for the manufacture of preparations other…

Persons engaged in national and international trade are required to draw up an annual summary statement indicating for each psychotropic substance or medicinal product containing it: 1° The quantities acquired on the national market ; 2° Quantities imported ; 3° Quantities sold on the national market; 4° Quantities exported; 5° Stocks. This statement, which covers the previous calendar year, is sent to the Director General of the Agence nationale de…

The provisions of article R. 5132-79, with the exception of those set out in 5° and 6° of the said article, apply to containers or packaging containing psychotropic substances or their preparations. The label must also bear : 1° For substances or preparations covered by list I, a skull and crossbones printed in black on a yellow orange square background of sufficient size; this square is placed in the top…

The managers of the establishments mentioned in articles L. 5124-2 and L. 5142-1 carrying out operations relating to medicinal products containing one or more psychotropic substances are subject to the provisions of articles R. 5132-91 to R. 5132-94.