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Article R5125-53 of the French Public Health Code

When dispensing a medicinal product or product other than that prescribed pursuant to article L. 5125-23, the pharmacist shall indicate on the prescription the name of the medicinal product or product dispensed, which, in the case of a proprietary medicinal product, is its name within the meaning of article R. 5121-1. He shall enter on the prescription the pharmaceutical form of the medicinal product dispensed if this differs from that…

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Article R5125-54 of the French Public Health Code

The express statement by which the prescriber excludes the possibility of substitution as provided for in the second paragraph of Article L. 5125-23 is as follows: “Non substitutable”. For prescriptions issued at the request of a patient for use in another Member State of the European Union, the statement provided for in the first paragraph is supplemented by a brief explanation of the reasons for excluding the possibility of substitution.

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Article R5125-55 of the French Public Health Code

Without prejudice to the provisions of Articles R. 5132-4 and R. 5132-29, a prescription expressed as a non-proprietary name pursuant to Article L. 5125-23 and as defined in Article R. 5121-1 must include at least : 1° The active ingredient of the medicinal product designated by its non-proprietary name ; 2° The strength of the active ingredient; 3° The route of administration and pharmaceutical form. If the medicinal product prescribed…

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Article R5125-56 of the French Public Health Code

On the basis of a prescription written in a non-proprietary name, the pharmacist dispenses a medicinal product complying with the information provided for in article R. 5125-55. However, the immediate-release oral pharmaceutical form of the medicinal product dispensed may be different from that indicated on the prescription in non-proprietary names, provided that the medicinal product dispensed is in the same generic group as the medicinal product prescribed.

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Article R5125-57 of the French Public Health Code

A medicinal product, whether simple or compound, held with a view to sale, offered for sale or sold, where one or more of the following particulars have been omitted from one of the components of its packaging, shall be considered to be a secret remedy: 1° For the preparations mentioned in 1° to 3° of article L. 5121-1, the name and address of the pharmacist who dispensed the preparation, except…

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Article R5125-58 of the French Public Health Code

For the purposes of article R. 5125-57, active substances are substances which are deemed to have medicinal properties, as well as those which the compounding pharmacist declares to contribute to the curative or preventive efficacy of the product. The name of each active substance means its common scientific name or its common name as defined in article R. 5121-1. Chemical symbols may only be used to supplement the name.

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Article R5125-59 of the French Public Health Code

The dose of each active substance is defined as : 1° either its weight per unit of intake determined ; 2° or its centesimal proportion by weight in the preparation; or 3° or, in the case of a product titrated in biological units, the number of units contained per dosage unit, per cubic centimetre or for a given quantity by weight of the product, with the definition of the biological…

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