Chapter III: Promotional communications

Any promotional communication relating to the plasmas referred to in Article L. 1223-3 shall specify the date on which it was drawn up or last revised and shall include at least the following information: 1° The name of the product as it appears in the decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioned in 1° of article L. 1221-8…

The elements contained in the promotional communication of the plasmas mentioned in article L. 1223-3 comply with the information contained in the corresponding part of the decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioned in 1° of article L. 1221-8 and with the recommendations of the Haute Autorité de santé mentioned in article L. 1223-2.

The establishment preparing the product must keep a copy of each promotional communication it issues for a period of three years from the date on which it was last disseminated, and must make this copy available to the Agence nationale de sécurité du médicament et des produits de santé, together with information about the recipients, the method of dissemination and the date on which it was first disseminated.

I. – When one of the plasmas mentioned in Article L. 1223-3 is the subject of a reassessment mentioned in the second paragraph of Article L. 1221-8-2, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall immediately inform the establishment preparing the product. He shall also inform it without delay of the result of this reassessment. II. – If the reassessment requires…

The information contained in the promotional communication is accurate, up-to-date, verifiable and sufficiently complete to enable healthcare professionals to assess the therapeutic value of the product. Quotations, tables and other illustrations borrowed from medical journals or scientific works, which are used in the promotional communication, are faithfully reproduced and the exact source is specified. A promotional communication which reproduces the position taken with regard to a plasma mentioned in article…

The oral presentation of a plasma referred to in article L. 1223-3 is carried out by a professional referred to in article L. 1223-7. It is accompanied by the hand-delivery by the latter to the healthcare professional of a written document containing the information mentioned in article R. 1223-1. This document contains sufficiently clear and legible information. It also includes the date on which it was drawn up or last…

I. – The application for authorisation referred to in article L. 1223-4 is made for all communications made to healthcare professionals authorised to prescribe, supply or use this product and in particular on the occasion of : 1° Presentation of the product by the professionals mentioned in article L. 1223-7 ; 2° Studies or surveys carried out among these health professionals; 3° Scientific meetings or congresses attended by these professionals,…

The timetable and period for submitting applications for the authorisations mentioned in article L. 1223-5 are set, for each year, before 1st November of the previous year. The timetable determines at least four periods per year, each lasting between one week and two months, during which applications may be submitted. Applications for authorisation are deemed to have been accepted if no decision is taken within two months of the day…

I. – In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation for a maximum period of three months. II. – Withdrawal of the authorisation may be ordered by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, under the conditions of the last paragraph of Article L. 1223-4, after…

I. – The provision of free samples of a plasma referred to in the second paragraph of article L. 1223-6 is only permitted during the two years following its initial inclusion or modification on the list of characteristics included 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) referred to in 1°…