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Article R5122-1 of the French Public Health Code

The information contained in advertising for a medicinal product must comply with the information given in the summary of product characteristics referred to in article R. 5121-21 and with the therapeutic strategies recommended by the Haute Autorité de santé referred to in article L. 5122-2. All advertising for a traditional herbal medicinal product includes, in addition to the information provided for in articles R. 5122-3 and R. 5122-8, the words:…

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Article R5122-2 of the French Public Health Code

The company marketing a medicinal product shall set up an advertising department within the meaning of article L. 5122-1, under the supervision of the pharmacist responsible, which shall ensure compliance with the provisions of sections 1 to 3 of this chapter, and in particular the scientific validity of the information disseminated. The company keeps a copy of each advertisement it issues for a period of three years from the date…

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Article R5122-2-1 of the French Public Health Code

When a medicinal product is the subject of a reassessment of the risk-benefit balance, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform the manufacturer without delay. He shall also inform the operator without delay of the completion and outcome of the reassessment. If the reassessment results in a change to the marketing authorisation or registration requiring a change to the…

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Article R5122-3 of the French Public Health Code

When permitted under the provisions of Article L. 5122-6, advertising of a medicinal product to the general public : 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a medicinal product; 2° Contains at least : a) The name of the medicinal product and the common name ; b) Information essential for the proper use of…

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Article R5122-4 of the French Public Health Code

Without prejudice to the provisions of Article L. 5122-7, advertising of a medicinal product to the general public may not include any element which : 1° Makes medical consultation or surgical intervention appear superfluous, in particular by offering a diagnosis or recommending treatment by mail order; 2° Suggest that the effect of the medicinal product is guaranteed, that it has no adverse effects, or that it is superior or equal…

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Article R5122-5 of the French Public Health Code

A schedule of periods for submitting the visa applications referred to in Article L. 5122-8 is set for each year, by decision of the Director General of the National Agency for the Safety of Medicines and Health Products published on the Agency’s website, before 1st November of the previous year. This schedule determines at least four periods per year, each lasting between one week and two months, during which applications…

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Article R5122-6 of the French Public Health Code

When the application is submitted, the applicant assigns an internal reference number to each of the advertising media, in accordance with the rules defined by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Advertising distributed to the public must mention this number, except in the case of advertising on a radio broadcasting medium.

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Article R5122-7 of the French Public Health Code

The withdrawal of the visa provided for in the third paragraph of Article L. 5122-8 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after the beneficiary of the visa has been invited, by any means which provides proof of the date of receipt of this notice, to present its written or oral observations within a period set by the…

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Article R5122-8 of the French Public Health Code

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…

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Article R5122-9 of the French Public Health Code

The information contained in the advertisement must be accurate, up to date, verifiable and sufficiently complete to enable the recipient to form a personal opinion of the therapeutic value of the medicinal product. Quotations, tables and other illustrations borrowed from medical journals or scientific works and used in advertising must be faithfully reproduced and the exact source specified. Advertising may not mention the position taken on a medicinal product by…

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