16.04.2018.
Amendments to the Procedure for Registration of Medicinal ProductsPlease note that the amendments to the Cabinet of Ministers Regulation No 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” came into force on 13 April 2018. The amendments specify the procedure for review, approval and rejection of variations of marketing authorisation documentation in order to ensure compliance with the European Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Read more |
