Advertising to the public for an in vitro diagnostic 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 an in vitro diagnostic medical device; 2° Specifies the date on which it was drawn up or the date of the last modification and includes at least the following information: a) The name or trade reference…
Advertising of an in vitro diagnostic 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 commercial reference of the in vitro diagnostic medical device; 2° The purpose assigned to the in vitro diagnostic medical device by its manufacturer and for…
The information contained in each advertisement shall be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the in vitro diagnostic medical device and professionals to appreciate the characteristics and performance of the in vitro diagnostic medical device. Quotations, tables and other illustrations borrowed from medical journals or scientific works, which are used in advertising, are faithfully reproduced and their…
Where the Director General of the Agence nationale de sécurité du médicament et de produits santé finds that advertising for an in vitro diagnostic medical device, which is not covered by the provisions of Articles R. 5223-5 to R. 5223-11, is being disseminated in a manner contrary to the provisions of Article L. 5223-2 and of this section, the Director General of the Agence nationale de sécurité du médicament et…
Applications for authorisation to advertise the in vitro diagnostic medical devices referred to in Article L. 5223-3 must be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person on whose behalf the advertising is to be disseminated, by registered letter or by electronic means with acknowledgement of receipt or by delivery against receipt. Each application for authorisation must…
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 prior authorisation decision 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 nationale…
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. 5223-5 is the subject of a new application for authorisation submitted and examined under the same conditions as the initial application for authorisation. The authorisation continues to run until its initial expiry date.
The 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 in vitro diagnostic medical device no longer complies with the conditions laid down by the provisions of Articles L. 5223-2 and L. 5223-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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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
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