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Article R5122-20 of the French Public Health Code

The application to obtain the endorsement referred to in Article R. 5122-19 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the manufacturer or distributor of the product. It must be accompanied by 1° The draft advertisement, whatever the medium, and in particular a copy of the draft labelling appearing on the primary and secondary packaging of the…

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Article R5122-21 of the French Public Health Code

The following information is exempt from advertising approval when it appears on labels, leaflets or brochures relating to the products referred to in Article L. 5122-14: 1° The name and composition of the product ; 2° Instructions for use and precautions for use, if applicable.

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Article R5122-22 of the French Public Health Code

For a product mentioned in Article L. 5122-14, the advertising approval for professionals mentioned in Article L. 5122-9 is issued and may be suspended or withdrawn under the conditions set out in Articles R. 5122-13 to R. 5122-16. The provisions of article R. 5122-20 are applicable to the application for an advertising visa. The advertisement also mentions the date on which it was last drawn up or revised. This information…

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Article R5122-26 of the French Public Health Code

Decisions to prohibit or make advertising or propaganda subject to the obligation to mention the warnings and precautions for use necessary to inform consumers, as provided for in article L. 5122-15, taken by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, are published in the Journal officiel de la République française.

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Article R5123-1 of the French Public Health Code

The prescription containing a prescription for medicinal products indicates, so that these medicinal products can be reimbursed by a health insurance organisation, for each of the medicinal products prescribed: 1° The dosage ; 2° Either the duration of treatment or, where the prescription includes the name of the medicinal product within the meaning of article R. 5121-2, the number of packaging units. However, if one or other of the details…

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Article R5123-2 of the French Public Health Code

A prescription for a medicinal product for a period of treatment of more than one month must indicate, in order for the cost of this medicinal product to be reimbursed, either the number of times the prescription may be renewed for periods of no more than one month, or three months for medicinal products packaged for a period of treatment of more than one month, or the total period of…

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Article R5123-2-1 of the French Public Health Code

In the case of chronic treatment, when the period of validity of a renewable prescription has expired, the pharmacist will dispense the medicinal products required to continue the treatment if the following conditions are met: 1° The prescription includes a prescription for the medicinal product allowing, in accordance with the provisions of article R. 5123-2, a total duration of treatment of at least three months; 2° This medicinal product does…

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Article D5123-4 of the French Public Health Code

The committee responsible for proposing the list of approved products for public authorities, in accordance with the provisions of articles L. 5123-2 and L. 5123-3, is the Transparency Committee, the composition and operation of which are set out in articles R. 163-15 to R. 163-21 of the Social Security Code.

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