Please be notified that Decree No 463/2021 on Detailed Conditions Governing the Conduct of Clinical Trials on Medicinal Products, which is an implementing legal regulation to the amended Act No 378/2007 Coll., on Pharmaceuticals, as amended by Act No 66/2017 (i.e. as per Regulation 536/2014) has been published in the Collection of Regulations of the Czech Republic.
https://www.sbirka.cz/POSL4TYD/NOVE/21-463.htm
Decree of 06 December 2021, published on 10 December 2021, effective date: 31 January 2022.
This Decree shall be applicable only to clinical trials submitted via the CTIS = EU portal and assessed pursuant to Regulation No 536/2014.
Department of Clinical Trials on Medicinal Products
14 December 2021
cz