The French medicines regulator (ANSM) recently launched a public consultation concerning the warning message that pharmaceutical companies must include in all audio-visual advertising of medicinal products to the public, as part of the mandatory information required for medicine advertising by Articles L. 5122-6 and R. 5122-3 of the French Public Health Code. The consultation concerns a draft recommendation that would revise the current mandatory information obligations by, among other things, streamlining the required warning message with the aim of strengthening its perception by the public in TV and movie theatre advertising.
The consultation touches upon two aspects:
- Defining a single warning message that would be required for all medicinal products, while possibly maintaining certain warning messages for specific products or product categories (for example, paracetamol, non-steroidal anti-inflammatory medicinal products).
- Improving the presentation of the warning message, whether in audio or written format.
The consultation is presented in the form of a multiple choice survey covering the following three queries (plus a free text box for additional comments):
- Choosing between two alternative proposed warning messages for advertisements on TV or cinema, or suggesting an alternative statement.
- Whether such general warning messages should be in audio or written format.
- Whether specific warning messages should be maintained for certain medicinal products and, if so, for which products or product categories.
Interested stakeholders must return the completed questionnaire by 19 September 2017 via email to the following address: email@example.com.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2017 Issue (Thomson Reuters).