For all medicines, whether they are available over the counter or by prescription only, all promotional documents intended for healthcare professionals and the public are subject to prior control by ANSM, i.e. before any distribution.
Promotional communication materials for therapeutic solvent/detergent plasmas (SD-plasma) are, given their medicine status, also subject to prior control.
Our role is to ensure the safety of the promotional message, which must be objective and encourage proper use in order to avoid giving rise to poor prescription or usage habits.
We also ensure that promotional materials are consistent with:
- Health authorities’ assessments and recommendations ;
- Campaigns to promote proper use, and public health programmes.
ANSM bases its decisions according to compliance with the following three criteria in particular (Article L.5122-2 of the French Public Health Code) :
- Compliance with the terms of the marketing authorisation (MA) and therapeutic strategies recommended by the French National Health Authority (HAS);
- An objective presentation of the medicine that promotes its proper use;
- Advertising must not be misleading or undermine public health protection.
Note
When the benefit-risk ratio of a medicine is being reassessed, it is prohibited to advertise the medicine until the process has been completed (Article L.5122-3 of the French Public Health Code).