No container or packaging that has been in contact with micro-organisms and toxins or products containing them mentioned in article L. 5139-1 may receive products intended for human or animal consumption.
The loss or theft of micro-organisms or toxins as well as products containing them, any incident or accident as well as any event likely to result in their dissemination must be immediately declared to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products).
Establishments in which operations are carried out on micro-organisms or toxins included on the list drawn up in application of article L. 5139-1 and identified as presenting the highest risks to public health must be subject to a special intervention plan set up in application of article L741-6 of the French Internal Security Code. An order of the Minister for Health, issued after consultation with the Director General of the…
The provisions of this section apply only to medicinal products appearing on the list established by order of the Minister for Health made on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé and after obtaining the opinion of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The provisions of this…
The prescription and supply of medicinal products containing micro-organisms or toxins other than those included on the list provided for in article R. 5139-26 is prohibited. The preparation of any preparations containing micro-organisms or toxins is prohibited. Apart from the operations necessary for their administration, a proprietary medicinal product for human use, a proprietary veterinary medicinal product or an auto-vaccine for veterinary use containing micro-organisms or toxins may not be…
Authorisation is not required for the acquisition, possession or transfer, whether free of charge or for consideration, of medicinal products covered by this section: 1° dispensing pharmacists, pharmacists managing mutual pharmacies, pharmacists managing pharmacies for internal use, doctors authorised to dispense medicinal products; 2° Veterinary surgeons, army veterinary surgeons, and veterinary surgeons or doctors of pharmacy appointed by the director of the French veterinary school as pharmacy managers; 3° The…
I.- All proprietary medicinal products for human use containing micro-organisms or toxins are prescribed in accordance with the conditions set out in articles R. 5132-3 and R. 5132-4. A prescription may not be made for a treatment period exceeding twelve months. II – Pharmacists dispense proprietary medicinal products for human use containing micro-organisms or toxins under the conditions set out in article R. 5132-6. Pharmacists are only authorised to dispense…
I.- Veterinary proprietary medicinal products and auto-vaccines for veterinary use containing micro-organisms or toxins are prescribed under the conditions mentioned in I, III and IV of article R. 5141-111. A prescription may not be made for a treatment period exceeding twelve months. II – Veterinary medicinal products and auto-vaccines for veterinary use containing micro-organisms or toxins are dispensed under the conditions set out in articles R. 5132-6 and R. 5132-7…
Persons authorised to supply proprietary medicinal products for human use, proprietary veterinary medicinal products, investigational medicinal products for human use or auto-vaccines for veterinary use containing micro-organisms or toxins must transcribe all entries and withdrawals in a register or record them on a specific computer system meeting the following conditions: 1° It must not be possible to modify the data once it has been validated; 2° It must be possible…
Tattoo products are rendered sterile using appropriate processes. They are supplied in a container which retains sterility until use. Multiple dose containers are authorised provided that the delivery of each dose does not compromise the sterility of the product remaining in the container, a dose being defined as the quantity of product used for a single person during a single session. The quality of the colouring substances complies with that…
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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