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Decree No 463/2021 on Detailed Conditions Governing the Conduct of Clinical Trials on Medicinal Products

Important notice for sponsors of clinical trials on medicinal products related to the coming into effect of Regulation No 536/2014.

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.

Vyhláška č. 463/2021 Sb., o bližších podmínkách provádění klinického hodnocení humánních léčivých přípravků – Ministerstvo zdravotnictví (gov.cz)

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.

December 14, 2021

Department of Clinical Trials on Pharmaceuticals