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).
Please scan the written request and send the pdf my e-mail to email@example.com.
Sale periods following withdrawal of marketing authorisation
The Animals Act does not stipulate the period in which a veterinary medicinal product can still be sold after the marketing authorisation has been withdrawn at the request of the authorisation holder.
The withdrawal of the marketing authorisation for a veterinary medicinal product must be implemented in a timely manner. Not only from a commercial perspective, but also in the interests of animal and public health. The following policy has been set out:
Following publication in the Government Gazette of the decision on withdrawal of the marketing authorisation:
- the manufacturer must cease production of the veterinary medicinal product.
- the stock must be delivered to the wholesale distributor within 6 months.
For other suppliers, such as a veterinarian and/or retailer, Article 5.7 of the Regulation on Veterinary Medicinal Products applies, which prohibits the supply to farmers of veterinary medicinal products that have reached the expiry date. By extension, this also applies to a farmer when applying the veterinary medicinal product.
The MEB Agency, Veterinary Medicinal Products Unit, will inform the following parties of a withdrawal of a marketing authorisation:
- the holder of the marketing authorisation in a withdrawal resolution stating the above-mentioned deadlines;
- the official gazette;
- the Veterinary Medicines Information Bank on the MEB Agency website.