Title III: Other regulated pharmaceutical products and substances

The production, including cultivation, manufacture, transport, import, export, possession, offering, transfer, acquisition or use and, in general, agricultural, craft, commercial and industrial operations relating to substances or preparations and plants or parts of plants classified as narcotics 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 and these plants or…

The authorisation provided for in Article R. 5132-74 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. The Director General of the Agency will notify the applicant of his decision within…

I.- By way of derogation from the provisions of the first paragraph of article R. 5132-74, the following shall take the place of authorisation, for professional use only : 1° Registration with the Order of Pharmacists for pharmacists who own a dispensary and for pharmacists who manage mutualist pharmacies; 2° Registration with the Order of Pharmacists of pharmacists managing an in-house pharmacy authorised in application of article L. 5126-7 ;…

The authorisation referred to in article R. 5132-74 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 veterinarian in charge, the acting veterinarian in charge, the delegated veterinarians and the assistant veterinarians. In the…

Apart from cases of transit or crossing customs territory, it is prohibited to import or export narcotics 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. 5132-75. The authorisation mentions the name and quantity of the product involved in the operation, the…

Containers or packaging containing narcotics and used for their import or export, transport or possession must bear a label of a size appropriate to their volume, affixed in such a way that it cannot be accidentally detached. This label bears, in indelible and legible black characters, the following information: 1° For a substance, a plant or a part of a plant: the international non-proprietary name recommended by the World Health…

Substances or preparations and plants or parts of plants classified as narcotics are kept in locked cabinets or premises containing nothing else. The physical conditions under which these substances and preparations are held are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health. Any theft or misappropriation is reported without…

The persons mentioned from 1° to 5° of the I of article R. 5132-76 may only acquire narcotic substances and preparations classified as narcotics in an establishment holding the authorisation provided for in the 1st paragraph of article R. 5132-75. The acquisition or transfer of narcotics is entered in a special register or recorded by a specific computer system meeting the following conditions: a) It must not be possible to…

Persons who manufacture, process or divide narcotics are required to record, at the time of the operation and thereafter, in the register provided for in article R. 5132-81 or to record using the computer system provided for in the same article : 1° The operations carried out ; 2° The nature and quantity of the narcotics used; 3° The nature and quantity of the products obtained; 4° The losses resulting…