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Changing an existing licence

A licence for the manufacture or importation of veterinary medicinal products (production) or for the wholesale or retail trade in veterinary medicinal products (distribution) can be requested from the MEB Agency, Veterinary Medicinal Products Unit. After the first licence has been granted, it is possible to apply for a change to the existing licence.

This part of our website is not up-to-date. The Veterinary Medicines Regulation has been in effect since 28 January 2022. The final national veterinary medicinal products legislation is not published yet. As soon as the final national veterinary medicinal products legislation is published, the Dutch web texts will be updated. Once these are ready, they will be translated into English. This will take some time. Therefore, check our website regularly for any updates.

Apply for, change or revoke a production and distribution license

  • You can apply for, change or revoke a retail license for veterinary medicinal products here.
  • You can apply for, change or revoke a wholesale license for veterinary medicines here.
  • You can apply for, change or revoke a manufacturer's or import license for the manufacture of veterinary medicinal products here.

Confirmation of receipt of the application will be sent to you in writing within 2 weeks, stating the application number, date and case number. The legal period for a decision on an amendment request is 30 days. This period can – when necessary - be lengthened so that you, as an applicant, can provide additional information for the completion of the licence requirements.

Change request for a production or distribution licence

A change request is needed if the situation - as described in the licence that was awarded - has changed. For example, with regard to:

  • the location where the licence has been issued
  • the name of the natural or legal entity to which the licence was granted
  • the activities (only applicable for a production (F) licence)
  • change in the authorised person/QP (only applicable for a production (F) licence)
  • changes to the list of outsourced procedures per veterinary medicinal product (only applicable for a production (F) licence)
  • changes to the product list (only applicable for a production (F) licence).

If the location at which the current licence has been issued changes, a new assessment of the new location takes place.

An application for changing the licence can be refused if you do not meet the licence requirements. This refusal may have consequences for the existing licence.

The costs for handling changes to an existing licence are stated under Fees and product types.