Part five: Health products

The production, manufacture, transport, import, export, possession, supply, transfer, acquisition or use and, in general, agricultural, craft, commercial and industrial operations relating to substances or preparations classified as psychotropic by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé are prohibited, unless expressly authorised. Where these substances or preparations are used in veterinary medicine, the Director General of the Agency will…

The authorisation provided for in Article R. 5132-88 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, for the pharmaceutical establishments within its remit. Modification of any of the elements mentioned in the application renders the authorisation previously…

I.- By way of derogation from the provisions of article R. 5132-88, the following shall take the place of authorisation for professional use only: 1° The authorisation issued in application of articles L. 5124-3 or L. 5142-2 ; 2° Registration with the Order of Pharmacists for pharmacists owning a dispensary and pharmacists managing mutualist pharmacies; 3° Registration with the Order of Pharmacists of pharmacists managing an in-house pharmacy authorised in…

The authorisation referred to in article R. 5132-88 may only be granted to a natural person. In the companies mentioned in articles L. 5124-2 and L. 5142-1, authorisation may be requested for the pharmacist in charge, the acting pharmacist in charge, the delegated pharmacists and the assistant pharmacists as well as for the veterinary surgeon in charge, the acting veterinary surgeon in charge, the delegated veterinary surgeons and the assistant…

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…