Advertising to the public for a medical device : 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a medical device; 2° Specify the date on which it was drawn up or the date of the last modification and include at least the following information: a) The name or commercial reference of the medical device ;…
Advertising of a medical device to healthcare professionals is tailored to the target audience. It specifies the date on which it was drawn up or the date of the last modification and includes at least the following information: 1° The name or trade reference of the medical device; 2° The purpose assigned to the medical device by its manufacturer and for which it is advertised, together with the characteristics and…
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the medical device and professionals to appreciate the characteristics and performance of the medical device. Quotations, tables and other illustrations borrowed from medical journals or scientific works and used in advertising must be faithfully reproduced and their exact source specified. Advertising may not…
Where the Director General of the Agence nationale de sécurité du médicament et des produits de santé finds that advertising for a medical device, which is not covered by the provisions of Articles R. 5213-5 to R. 5213-11, is being disseminated under conditions which contravene the provisions of Article L. 5213-2 and of this section, he may give formal notice to the person on whose behalf the advertising is being…
The application for authorisation to advertise the medical devices referred to in Article L. 5213-4 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person for whose benefit the advertising is to be disseminated, by registered letter or by electronic means with acknowledgement of receipt or delivered against receipt. Each application for authorisation must be accompanied by…
The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised characteristics and performances.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receipt of the complete dossier. Authorisation is deemed to have been granted in the absence of a decision by the Director General of the Agency within this period. If the applicant’s documents are not complete, the Agence…
The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a period of five years.
Any project to modify the elements mentioned in 1° and 2° of article R. 5213-5 is the subject of a new authorisation application submitted and examined under the same conditions as the initial authorisation application. This authorisation continues to run until its initial expiry date.
Authorisation may be suspended or withdrawn by reasoned decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé where the advertising of the medical device no longer complies with the conditions laid down by the provisions of Articles L. 5213-2 and L. 5213-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after the holder has been…
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
