Dear clients!

Dear clients!

Information regarding the annual post-authorisation maintenance fee for medicines

The State Agency of Medicines (hereinafter - SAM) would like to point out that in accordance with Article 85 of the 9th May 2006 Cabinet of Ministers Regulation No. 376 "Procedure for the Registration of Medicinal Products" the expenditures of post-authorisation maintenance of medicines shall be covered by the marketing authorisation holder. Article 85.6 of the Regulation No. 376 states that the annual post-authorisation maintenance fee for medicines shall be applied in the next calendar year following the marketing authorisation or renewal of medicinal product.

Basing on an application submitted by the marketing authorisation holder SAM has the right to adopt a decision regarding exemption from the annual post-authorisation maintenance fee, if all of the following requirements have been fulfilled during the previous calendar year:

1) the price of medicines has been declared in SAM in accordance with the normative acts regarding determination of the price of medicinal products;
2) the medicines are distributed in Latvia, but the turnover during the previous calendar year does not exceed 1500 Ls;
3) in accordance with the requirements of normative acts regarding procedure for distribution of medicinal products, the marketing authorisation holder has reported to SAM the actual date of beginning of distribution (marketing) of medicines in Latvia or has reported the medicines withdrawn from the market of medicines in Latvia (temporarily or permanently).

We remind you that the marketing authorisation holder has the right to submit the application for exemption from the annual post-authorisation maintenance fee during the entire year whether all the three of aforementioned requirements have been fulfilled. Please note that the application for exemption from the annual post-authorisation maintenance fee for medicines can be submitted regardless whether or not the marketing authorisation holder has received the appropriate invoice from SAM.