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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:

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.

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:

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