From 16 June 2016 information regarding all MRP/DCP variations* with a positive outcome will be published on the website of the State Agency of Medicines

From 16 June 2016 information regarding all 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 16 June 2016 information regarding all 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. After publishing information regarding variations with a positive outcome on the SAM website submitters of variation applications will receive an informative e-mail (with the link to the SAM website).

Before this informing procedure was applied only to MRP/DCP variations with a positive outcome that were not related to amendments to the product information.

* excluding variations, which include time for the distribution of the remaining stocks of medicines, and variations which are related to the issue of an updated marketing authorization.