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Article R5139-20 of the French Public Health Code

On a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the following are set: 1° By order of the Minister for Health: a) The maximum doses and concentrations of the micro-organisms and toxins on the list provided for in Article L. 5139-1 above which products containing them are subject to the provisions of this chapter; b) Information appearing on the…

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Article R5139-21 of the French Public Health Code

The production, manufacture, transport, import, export, possession, offer, transfer, acquisition and use of micro-organisms and toxins or products containing them in a form or under a name liable to cause confusion or to mislead as to their properties or dangerousness are prohibited.

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Article R5139-22 of the French Public Health Code

It is forbidden to mark containers or packaging containing micro-organisms or toxins and products containing them as non-toxic, non-harmful or any other similar indications. Without prejudice to the regulations concerning the transport of dangerous goods, containers or packaging containing micro-organisms or toxins and products containing them, used for their import, export or transport, must be labelled in accordance with the rules of good practice mentioned in article R. 5139-18.

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Article R5139-24 of the French Public Health Code

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).

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Article R5139-25 of the French Public Health Code

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…

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Article R5139-26 of the French Public Health Code

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…

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Article R5139-27 of the French Public Health Code

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…

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Article R5139-28 of the French Public Health Code

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…

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Article R5139-29 of the French Public Health Code

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…

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