Information for marketing authorisation holders

Information for marketing authorisation holders

State Agency of Medicines of Latvia (hereinafter - SAM) informs that Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (hereinafter - Regulation), Chapter IIa "Variations to purely national marketing authorisations" requirements regarding variation evaluation procedure for nationally authorised medicinal products will come into effect on August 4th 2013. Read more