Withdrawal of a marketing authorisation veterinary medicinal product
If you wish to withdraw a marketing authorisation for a veterinary medicinal product, you must submit a signed written request stating which product (name + REG NL) you wish to withdraw and as of when (date).
This written request can be submitted using the contact form.
Delivery timeframes following withdrawal of a marketing authorisation
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and the national legislation do not stipulate a permitted timeframe for supplying a veterinary medicinal procedure once its marketing authorisation has been withdrawn at the request of the marketing authorisation holder.
It is important that the withdrawal of a marketing authorisation for a veterinary medicinal product is implemented in a timely manner, not only from a commercial perspective but also in the interest of animal health and public health. The following policy has been adopted in this regard:
Following the publication of the decision to change the marketing authorisation:
- the manufacturer is no longer allowed to manufacture the veterinary medicinal product;
- existing stock of batches that have already been released can be delivered to the wholesale and/or retail trade for a maximum period of 6 months.
Other suppliers, such as veterinarians and/or the retail trade, must comply with the ban on the provision of expired veterinary medicinal products to animal keepers, as laid down in article 3.2(1), item b of the Veterinary Medicines Regulations 2022. By extension, the same rule applies to animal keepers when using the veterinary medicinal product.
The Veterinary Medicinal Products Unit will report the withdrawal of a marketing authorisation:
- to the marketing authorisation holder, by means of a withdrawal decision stating the timeframes referred to above;
- in the Veterinary Medicines Information Database.