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Article R5132-12 of the French Public Health Code

A quantity of medicinal products corresponding to a treatment period of more than four weeks or one month of thirty days, depending on the packaging, may not be dispensed on a single occasion. However, medicinal products packaged for a treatment period of more than one month may be dispensed for this period, up to a maximum of three months. In addition, contraceptive medicines, regardless of their packaging, may be dispensed…

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Article R5132-13 of the French Public Health Code

After dispensing, the prescription or order form must bear : 1° The pharmacy stamp ; 2° The registration number(s) provided for in article R. 5132-10 ; 3° The date of dispensing; 4° The quantities dispensed; 5° Where applicable, the information provided for in the first paragraph of article R. 5125-53.

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Article R5132-14 of the French Public Health Code

Renewal of the supply of a medicinal product or preparation covered by this section may only take place after a specific period of time resulting from the dosage and quantities previously supplied. Renewal is subject to a new registration. When the renewal is made by the same dispenser, the registration may consist solely of the number relating to the previous dispensing. The same indications as those listed in article R….

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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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