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Article R5132-15 of the French Public Health Code

The outer packaging of medicinal products covered by this section shall include : 1° If the medicinal product is intended for humans, a white space, surrounded by a coloured line, in which the dispensing pharmacist or doctor writes the prescribed dosage; if it is a medicinal product classified as a narcotic or subject to narcotic regulations, the dispensing pharmacist or doctor also writes his name, address and the reference number…

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Article R5132-16 of the French Public Health Code

The provisions of 1° of article R. 5132-15 do not apply to the medicinal products mentioned in 2° and 3° of article R. 5124-43. However, the words: “Reserved for professional use”, surrounded by a coloured line, are shown on the outer packaging, directly under the special name of the pharmaceutical speciality or product. The provisions of 2° of article R. 5132-15 do not apply to the medicinal products mentioned in…

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Article R5132-17 of the French Public Health Code

It is prohibited to use, for the medicinal products mentioned in article R. 5132-1, containers or packaging bearing the name of a product intended for human or animal consumption or likely to create confusion with such a product. No container or packaging which has contained these medicinal products may be reused to receive products intended for human or animal consumption.

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Article R5132-18 of the French Public Health Code

The label of magistral or officinal preparations intended for veterinary medicine covered by the regulations of this section must include the following information: 1° Name and address of the pharmacist or dispensing veterinarian ; 2° Registration number ; 3° Posology and instructions for use. The label is white when the medicinal product is intended for the nasal, oral, perlingual, sublingual, rectal, vaginal or urethral route or is injectable. It is…

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Article R5132-19 of the French Public Health Code

The managers of the establishments referred to in articles L. 5124-2 and L. 5142-1 and the natural or legal persons authorised to place orders with them must, at all times, provide proof of the acquisition and transfer of the medicinal products referred to in article R. 5132-1. The supporting documents are kept for at least three years, subject to the specific provisions applicable to narcotics and psychotropic drugs. The managers…

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Article R5132-21 of the French Public Health Code

A prescription for medicinal products in lists I and II may not be made for a treatment period of more than twelve months. However, for public health reasons, in the case of certain medicinal products, psychotropic substances or substances likely to be used for their psychoactive effect, this period may be reduced by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de…

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Article R5132-22 of the French Public Health Code

Pharmacists are only authorised to dispense these medicines for the first time on presentation of a prescription less than three months old. List I medicinal products may only be renewed if the prescriber gives a written indication specifying the number of renewals or the duration of treatment. List II medicinal products may be renewed if the prescriber has not expressly forbidden this. In all cases, the renewal(s) may only be…

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Article R5132-23 of the French Public Health Code

The conditions under which List I and List II medicinal products are prescribed, held or distributed may, on public health grounds, be made subject, in whole or in part, to the provisions of sub-section 3 of this section by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

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Article R5132-24 of the French Public Health Code

Containers or packaging containing medicinal products from lists I and II which have not been packaged for the public must bear a label of a size appropriate to their volume, affixed in such a way that it cannot be accidentally detached. This label must clearly show, in legible and indelible characters, the following information: 1° The name of the contents ; 2° The name or business name and address or…

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