From 5 February 2016 information regarding MRP/DCP variations with a positive outcome will be published on the website of the State Agency of Medicines

From 5 February 2016 information regarding MRP/DCP variations with a positive outcome will be published on the website of the State Agency of Medicines

Information for marketing authorisation holders

The State Agency of Medicines (SAM) informs that from 5 February 2016 information regarding variations with a positive outcome for medicines authorised in mutual recognition and decentralised authorisation procedures (MRP/DCP), where Latvia is a Concerned Member State, will be published on the SAM website in the Section “Pakalpojumi → Humāno zāļu reģistrācija, pārreģistrācija un izmaiņas → Rīkojumi par zāļu reģistrāciju (Izmaiņas Latvijas Zāļu reģistrā (ar paziņojumu) – pielikums Nr. 3-3) in Latvian. It will be applied only to MRP/DCP variations with a positive outcome that are not related to amendments to the product information.

After publishing information regarding variations with a positive outcome on the SAM website submitters of variation applications will receive an informative e-mail (the link to the SAM website).