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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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