Chapter III: Promotional communications

Promotional communication relating to plasmas means any form of information, including canvassing, canvassing or inducement intended to promote the prescription, supply, sale or consumption of these products. This definition does not include 1° Information provided, as part of their duties, by staff working for the Etablissement français du sang and the armed forces blood transfusion centre, the blood depots of health establishments and armed forces hospitals, and by haemovigilance and…

The promotional communication defined in article L. 1223-1 must not be misleading or undermine public health protection. It must present the product objectively and encourage its proper use. It must comply with the information contained in the decision of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) establishing the list and characteristics of labile blood…

The only plasmas that may be the subject of promotional communication are those in the production of which no industrial process is involved, mentioned in the second paragraph of article L. 1221-8, if they are included in the decision establishing the list and characteristics of labile blood products mentioned in the same article, and if they are not the subject of a measure provided for in article L. 1221-10-1. Promotional…

Promotional advertising of the plasmas mentioned in article L. 1223-3 to members of the health professions authorised to prescribe or supply these labile blood products or to use them in the exercise of their profession is subject to prior authorisation from the Agence nationale de sécurité du médicament et des produits de santé. This authorisation is valid subject to the inclusion of these plasmas on the list of labile blood…

The applications for authorisation provided for in Article L. 1223-4 are made according to a timetable and during a period determined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The distribution of free samples of labile blood products is prohibited. However, it is authorised for the plasmas mentioned in article L. 1223-3, outside areas accessible to the public on the occasion of medical or pharmaceutical congresses, when it is only given to persons authorised to prescribe or purchase these products, solely at their request, and when the product or its packaging bears the words “free sample”. Promotional communication of…

Persons who provide information by canvassing or canvassing for plasmas mentioned in article L. 1223-3 must have scientific knowledge attested by a State diploma of doctor of pharmacy or pharmacist within the meaning of article L. 4221-2 or by a State diploma of doctor of medicine within the meaning of article L. 4131-1. The Etablissement Français du Sang and the Armed Forces Blood Transfusion Centre ensure that the knowledge of…

The procedures for applying this chapter and in particular the conditions for issuing, suspending and withdrawing the authorisation for promotional communication provided for in article L. 1223-4 are defined by decree in the Conseil d’Etat.