The ANSM’s recommendations for developing promotional material are numerous and strict, and it is advisable to have your material checked and corrected by a regulatory expert.
Once this review has been completed, the material will be submitted to public authorities for approval via the “Simplified procedures” platform. The submission of the advertising material must be accompanied by the payment of a fee paid in advance.
When all the elements necessary for filing are ready, the submission of these documents on this platform can only be done during periods defined in advance by the ANSM. For advertisements targeting health professionals, this review is open 4 times a year and each period lasts approximately 20 days.
The ANSM will provide a reply regarding the conformity of your document within two months following the date of the end of the submission.
In case of explicit or tacit agreement from the authorities, you will obtain an advertising visa which should be included on the material. This visa is valid for 2 years.
Cevidra offers all support activities to obtain authorization of promotional documents, such as regulatory review, preparation of the material by a graphic designer and submission to the Agency.