French Public Health Code
In forceWhere 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 disseminated, within a specified period which may not be less than one month, to rectify the situation and withdraw the advertising until it is brought into compliance. Correcting the situation may involve changing the content of the advertisement or the persons to whom it is addressed, and possibly distributing a correction.
The formal notice is sent by any means that provides proof of the date of receipt and informs the interested party of the opportunity to submit written or oral observations within the period mentioned in the previous paragraph.
The formal notice may be accompanied by a daily penalty due, depending on the case, until the advertising is rectified or withdrawn. The amount of the fine may not exceed the amount set in the second paragraph of article L. 5421-9.
If the formal notice has not been acted upon by the end of the period set, the Director General may prohibit the continuation and further dissemination of the advertisement. He will inform the person concerned by any means that can be used to prove the date of receipt. The ban will be published on the Agency's website.
