date: 19/11/2021
Since 25 March 2020, shortened deadlines have been used for applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. As the vaccination campaign has reached the majority of the population, these reduced timelines are now extended to 15 calendar days.
Applications will be processed in fifteen calendar days for clinical trials:
- that follow the normal procedure, described in Article 13, § 1 of the Law of 7 May 2004 on experiments on the human person (further: Experiments law);
- that follow the procedure for pilot projects, described in Article 34/1, § 1 of the Experiments law;
- with advanced therapies (somatic cell therapy medicinal products, tissue engineered products or gene therapy medicinal products), described in Article 17 of the Experiments law;
- for medicinal products containing genetically modified organisms (GMOs), described in Article 17 of the Experiments law.
If Article 16 of the same law is used or if the FAMHP requests additional information, the FAMHP will process the application within five calendar days of receipt of the additional elements.
The application will be processed even if the contribution has not yet been paid. The contribution will be invoiced afterwards.
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Circular 653