Amendments to the paid service price list of the State Agency of Medicines

Amendments to the paid service price list of the State Agency of Medicines

Please note that the 22 December 2015 Cabinet of Ministers Regulation No. “Amendments to the 17 September 2013 Cabinet of Ministers Regulation No. 873 “State Agency of Medicines Publicly Available Paid Service Price List”” come into force on 1 January 2016. The text of the amendments is available here.

The aforementioned amendments to the price list of paid services of the State Agency of Medicines (hereinafter - SAM) introduce the following changes for marketing authorisation holders that might promote a greater competition in the market of medicines:

• From now on SAM will accept and adopt a decision regarding waiving the annual post-authorisation maintenance fee, if the turnover of medicines during the previous calendar year will not have exceeded 3000 EUR. Upon reviewing the decision regarding waiving of the annual post-authorisation maintenance fee, the condition regarding the annual turnover not exceeding 3000 EUR will be assessed, basing on the turnover data for 2015.
• In order to promote marketing authorisation of medicines in Latvia, SAM ensures a 90% discount from the marketing authorisation fee in the national marketing authorisation procedure for expertise on the application and additional documentation for marketing authorisation of similar medicines – generic medicines or biosimilar medicines.

17 September 2013 Cabinet of Ministers Regulation No. 873 "State Agency of Medicines Publicly Available Paid Service Price List” (including amendments coming into force on 1 January 2016).See here.