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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.

 

 

Regarding application of annual pharmacovigilance fee

Compliance with pharmacovigilance requirements is a mandatory condition for all marketing authorisation holders in accordance with EU legislative acts. In accordance with the Section 10, Article 18 of the Pharmaceutical Law the State Agency of Medicines (hereinafter - the Agency) performs the functions of pharmacovigilance, including supervision of the adverse effects caused by the use of medicinal products, as well as creates and maintains a database in relation to supervision of safe use of medicinal products. By ensuring the aforementioned functions the Agency streamlines the requirements laid down for supervision of the safety of medicinal products, as well as establishes a team of competitive experts to ensure these tasks, therefore, a paid service has been established for the performance of pharmacovigilance related functions - an annual pharmacovigilance fee for medicinal products authorised through the national procedure (including mutual recognition and decentralised procedure). The annual pharmacovigilance fee includes.. Read more

 

 

State Agency of Medicines Service Fees in Euros

The State Agency of Medicines informs that new Cabinet of Ministers regulations “State Agency of Medicines Publicly Available Paid Service Price List” (17th September 2013, CM Regulation No 873) have come into force on 1st of January 2014 where service fees are listed in euros. The new regulation replaces 29th of January 2013 CM Regulation No 75 “State Agency of Medicines Publicly Available Paid Service Price List”. The price list is available here (with amendments from September 2nd, 2014).

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Last changes made on 18.10.2017.