Administration of the post-marketing surveillance annual fee for veterinary medicinal products

The charge for services provided in the circulation of the post-marketing surveillance annual fee for veterinary medicinal products (annual fee) is collected by the Food and Veterinary Service (FVS) in accordance with the points 8.¹¹ - 8.¹² to the Cabinet Regulations “Procedures for the Authorisation of Veterinary Medicinal Products” (Regulation No. 600).

The annual fee is applied once a year until February 28 of the current year for all veterinary medicinal products included in the Register of Veterinary Medicinal Products of Latvia, except veterinary medicinal products for parallel trade, centralized veterinary medicinal products, veterinary medicinal products not authorised in Latvia and those veterinary medicinal products registered in the previous year in Latvia.

The FVS prepares for each marketing authorization holder (MAH) a payment explanation and an invoice for the annual fee for those veterinary medicinal products for which the annual fee is applied in the current year and sends it to MAH by February 28 of the current year to the electronic mail address of MAH.

The payment for the annual fee must be made by July 31 of the current year, indicating the invoice number in the payment order.

MAH has the right to apply for:

1. relief for the annual fee, if the total turnover of the relevant veterinary medicinal products distributed in Latvia in the previous calendar year does not exceed 2 000,00 euro;
2. exemption from the annual fee, if the total turnover of the relevant veterinary medicinal ptoducts distributed in Latvia in the previous calendar year does not exceed 1 000,00 euro.

In order to receive an exemption or relief for the annual fee, MAH or its authorized representative shall submit until May 31 of the current year an application to the FVS for products which were sold in Latvia by the person (wholesaler(-s), e.g. official distributor(-s)) to whom MAH directly has sold products in previous calendar year. Following information should be included in the application:

• product name;
• marketing authorisation number;
• package size;
• exact turnover (euro) which consists of:
  • number of packages sold by wholesaler;
  • marketing authorisation holder price of sold packages (euro).

Please use following format:

Please include in the application only those products for which the exemption and/or the provision of relief to the annual fee of post-marketing surveillance is requested.

Please note if the application is submitted by an authorized representative of a legal entity, a power of attorney must be attached to the application (including the representation in state institutions) in Latvian language or in foreign language with a legally valid translation into Latvian.

To the application must be added a document by which it can be unequivocally concluded that the person giving the application or the power of attorney (company representative) has the right to represent the company (an official confirmation/certificate from the Register of Enterprises of your country, claiming that the signer is the person who has the rights to act on behalf of the company).

There are available 3 options for the completed application (an application + a power of attorney (if necessary) + an official confirmation/certificate from the Register of Enterprises of your country) submission to the FVS:

1. the handwritten application can be sent by post to the address of the FVS or can be submitted in person at the FVS (Peldu street 30, Riga, Latvia, LV-1050); or
2. the application signed with a secure electronic signature can be sent to the email vzr@pvd.gov.lv (the document details "signature" and "date" are not filled in this case); or
3. the application can be submitted to vzr@pvd.gov.lv via Eudralink or CESP.

The FVS in accordance with the procedure established by the Law on Administrative Procedure, but no later than June 30 of the current year makes a decision to grant or not to grant an exemption from the annual fee or a relief to the annual fee.