Section 3: Advertising aimed at the health professions

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…

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…

When a medicinal product is subject to the restricted prescription conditions laid down in section 8 of chapter I of this title, it may only be advertised to prescribers authorised to draw up the prescription and to pharmacists practising in establishments capable of dispensing the medicinal product.

The verbal presentation of a medicinal product is made by a person mentioned in Article L. 5122-11 and is accompanied by the hand-delivery by that person to the healthcare professional of: 1° The summary of product characteristics referred to in article R. 5121-21 ; 2° The information provided for in 13°, 14° and 15° of article R. 5122-8 ; 3° the opinion issued in application ofarticle R. 163-4 of the…

Pursuant to Article L. 5122-1, an application for an advertising approval for a medicinal product, as provided for in Article L. 5122-9, is made for any form of information, as defined by Article L. 5122-1, communicated to healthcare professionals authorised to prescribe, dispense or use this medicinal product in the exercise of their profession, in particular on the occasion of: 1° The presentation of the medicinal product to these professionals…

A schedule of periods for submitting the visa applications referred to in Article L. 5122-9 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…

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 healthcare professionals must mention this number, except in the case of advertising on a radio broadcast medium.

Withdrawal of the approval provided for in the third paragraph of Article L. 5122-9 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after the beneficiary of the approval has been invited, by any means capable of proving the date of receipt of this notice, to present its written or oral observations within a period set by the Director General,…

For reasons relating to the protection of public health, the measures provided for in article R. 5122-15 may be taken in the event of misuse, as defined in article R. 5121-153, or drug dependence or abuse, as defined in article R. 5132-97, of the medicinal product being advertised.

I.-The provision of free samples referred to in article L. 5122-10 is only permitted during the two years following the first effective marketing in France of : 1° a proprietary medicinal product that has been registered or authorised for the first time; or 2° A medicinal product which has already been registered or authorised and which has obtained a registration or a marketing authorisation for a new strength or a…