Focus

COVID-19: The French competent health authority (ANSM) modifies the advertising visas calendar

30 April 2020 Marie SANCHEZ

Due to the state of health emergency established by the emergency law of March 23rd, 2020, the ANSM published earlier this month a new schedule for filing and granting advertising visas for medicinal products intended for the general public (GP) or healthcare professionals (HCP).

This new calendar results from the application of Ordonnance n°2020-306 of March 25th, 2020 relating to the extension of deadlines expired during the health emergency period and to the adaptation of procedures during that same period, which sets out a legally protected period until June 24th, 2020. The purpose of this legally protected period is to allow the adjustment of the deadlines and procedures for the examination of files by the administrative authorities.

In practice, the consequences of this modified timetable are as follows:

• For advertising visas that expire during the legally protected period: they will be automatically extended until December 31st, 2020, provided that no decision aiming at modifying or terminating them has been issued before March 12th, 2020;
• For advertising visas which should have started during the legally protected period, the filing periods will be merged with the filing periods normally foreseen at the end of the legally protected period. The filing periods for these visas will therefore be:

• • Advertising visas for GP: from June 25th to July 3rd, 2020;
  • Advertising visas for HCPs: from June 25th to July 24th, 2020.

• For advertising visas which started before the legally protected period, the evaluation periods are suspended and will resume for the period remaining to run on June 24th, 2020. Consequently, the evaluation period of these visas will end on the following dates:

• • Advertising visas for GP: August 12th, 2020;
  • Advertising visas for HCPs: July 15th, 2020.

The ANSM specifies that beyond these dates and in the absence of an express response from the ANSM, visas will be deemed tacitly granted. However, no implicit visa will be acquired during the legally protected period.

• Exceptionally, the ANSM authorizes the use of promotional materials normally intended to be distributed during medical visits and for which the advertising visa is still valid, to be used during visits carried out remotely through the internet or telephone platforms, provided that such use and communication is performed in compliance with the rules described in the Charter for the communication and promotion of health products on the internet.

These postponements will inevitably result in a bottleneck of the evaluation services at the end of the legally protected period. In order to avoid these complications, but also to limit the risk that many advertising visa requests be rejected, the ANSM recommends that manufacturers:

• Prioritize their advertising visa requests;
• Limit their requests to 3 advertising materials per product (all pharmaceutical forms and all dosages combined), per medical device or in vitro diagnosis medical device;
• Limit their requests to 3 advertising materials per therapeutic indication in the case of products with several therapeutic indications.