Advertising your medical device in France during the state of health emergency
Advertisement of medical devices is regulated in France by the Loi Bertrand. For certain types of medical device, advertising requires a prior authorisation by the ANSM (National Agency for the Safety of Medicines and Health Products) called a “visa”. The ANSM has published on their website an update on the “visa” procedures during the state of health emergency declared in France following the Covid-19 outbreak.
According to the 1st article of the order #2020-306 dated March 25th, 2020, the period stretching from March 12th to June 24th, is “legally protected”. This implies that if you have submitted a visa application and the 2 months evaluation period by the ANSM was due to end within this time-frame, the evaluation counter is frozen and will re-start after June 24th. If you have submitted a visa application with an evaluation period due to start after March 12th and end before June 24th, the counter being frozen, the evaluation period will start on June 24th.
Regarding the advertisement visas that were to expire during the “legally protected” period, their validity is extended until December 31st, 2020.
Additionally, in order not to overload the visa services after the 24th of June (which could lead to a high number of rejected applications), the ANSM advises manufacturers to prioritise their requests as well as limiting to 3 the number of advertising medium per therapeutic area.
For more information, please visit the ANSM website.