Section 3: Advertising aimed at the health professions

Articles in this section · 10

R5122-8R5122-9R5122-10R5122-11R5122-12R5122-13R5122-14R5122-15R5122-16R5122-17

Article R5122-8

French Public Health CodeIn force
Ask for lawyer reviewed or certified translation

Updated 2 Nov 2023

Advertising for a medicinal product to the healthcare professionals mentioned in Article L. 5122-9 is tailored to the target audience. It specifies the date on which it was drawn up or last revised and includes at least the following information:

1° The name of the medicinal product ;

2° The name and address of the company manufacturing the medicinal product;

3° The pharmaceutical form of the medicinal product;

4° The qualitative and quantitative composition in active ingredients, with the common name, and in constituents of the excipient, knowledge of which is necessary for the correct administration of the medicinal product;

5° The marketing authorisation or registration numbers;

6° The essential pharmacological properties with regard to the therapeutic indications;

7° Therapeutic indications and contraindications;

8° The method of administration and, if necessary, the route of administration;

9° Dosage ;

10° Undesirable effects;

11° Special warnings and precautions for use;

12° Drug and other interactions;

13° The prescription and dispensing classification of the medicinal product as stated in the marketing authorisation;

14° The maximum sale price to the public when such a price is set in application of the laws and regulations in force, accompanied, in this case, by the cost of daily treatment;

15° The status of the medicinal product with regard to reimbursement by health insurance organisations or approval for public authorities as provided for in article L. 5123-2;

16° For a generic medicinal product, a reference to this status and, if the generic group to which the medicinal product belongs includes one or more reference medicinal products, the statement: "This medicinal product is a generic of", followed by the name of the reference medicinal product(s), its strength and pharmaceutical form. In this case, the advertisement also includes the statement: "This medicinal product is included in the generics register. When substituting a medicinal product, consult the list of excipients with a known effect on the packaging and the generics register for any warnings. "However, for advertising on radio, only the mention that the product is generic is required.

Mariela Petrova

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A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

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Mariela Petrova

Mariela Petrova

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Toque #C2396

15+ Years In Corporate Practice

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Communications protected by professional secrecy — secret professionnel de l'avocat, Article 66-5 of the Law of 31 December 1971.

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