According to point 62. of the Cabinet of Minister’s Regulations No. 600 of July 18, 2016 “Marketing Authorisation of Veterinary Medicinal Products”, following the receipt of a marketing authorisation the holder (henceforth – MAH) thereof shall inform the Food and Veterinary Service (henceforth – FVS) of:
- the day that the registered veterinary medicinal product is put on the market, taking into account the registered pharmaceutical forms;
- 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 holder (owner) of the marketing authorisation 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.
According to point 67 of the Cabinet of Minister’s Regulations No. 600 of July 18, 2016 “Marketing Authorisation of Veterinary Medicinal Products”, 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 Food and Veterinary Service, 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 in Paragraph 67 of this Regulation, if a submission is received by MAH of the veterinary medicinal product marketing authorisation regarding the retention of the operation of the relevant veterinary medicinal product marketing authorisation.
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.
Options of the completed and signed form submission:
- electronically by sending e-mail to firstname.lastname@example.org via Eudralink or CESP;
- by post (Division of the Marketing Authorisation for Veterinary Medicinal Products, Peldu Street 30, Riga, LV 1050, Latvia).