In accordance with the point 62 to the Cabinet Regulations “Procedures for the Authorisation of Veterinary Medicinal Products” (Regulation No. 600) the marketing authorization holder (MAH) shall inform the Food and Veterinary Service (FVS) of:
- the day when the authorised veterinary medicinal product is put on the market, taking into account the registered pharmaceutical forms, or;
- the time period for which the putting of the veterinary medicinal product on the market or the withdrawal of the veterinary medicinal product from the market was suspended. The MAH shall notify the information referred to not later than two months before the day when the putting of the veterinary medicinal product on the market is suspended, except extraordinary circumstances.
In accordance with the point 67 to the Regulation No. 600 a marketing authorisation shall be considered to be invalid if none of the pharmaceutical forms or the type of sales packaging:
- are placed on the market within three years after the taking of the decision regarding the authorisation of the relevant veterinary medicinal product;
- are sold for three years in succession following the putting on the market thereof.
The FVS, taking into account extraordinary circumstances and considerations of the protection of human or animal health, is entitled to make exceptions in respect of the conditions referred to the point 67 to the Regulation No. 600, if the MAH has submitted an application regarding the retention of the operation of the relevant veterinary medicinal product marketing authorisation to the FVS.
Please use the form to inform the FVS about placing on the market and interruption to distribution of the veterinary medicinal product.
The form must be completed for:
- initial placing of the veterinary medicinal product on the market;
- interruption of the veterinary medicinal product;
- resumption of distribution of veterinary medicinal product following interruption.
There are available 3 options for the completed form submission to the FVS:
- 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
- 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
- the application can be submitted to vzr@pvd.gov.lv via Eudralink or CESP.
The form of marketing status notification of veterinary medicinal product are available HERE .