Information for marketing authorisation holders

Information for marketing authorisation holders

The State Agency of Medicines (hereinafter - SAM) reminds you that the requirements regarding procedure for examination of variations for nationally authorised medicinal products laid down by the Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products (hereinafter - Regulation), Chapter IIa “Variations to purely national marketing authorisations” shall come into force on August 4th, 2013. Read more