First application for licence
A licence for the manufacture or importation of veterinary medicinal products (production) or wholesale or retail trade in veterinary medicinal products (distribution) can be requested from the Veterinary Medicinal Products Unit.
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.
You apply for a licence via the following application form:
- (first) application for licence
Would you like to request a change to an existing licence? Then look under Changing an existing licence.
The application form including the annexes mentioned therein must be completed and returned to: case@cbg-meb.nl.
Receipt of the application will be confirmed to you in writing within 2 weeks, stating the application number, date and case number. The legal deadline for a decision on a (complete) application is 90 days. This period can be suspended – where necessary – so that you, as an applicant, can provide additional information regarding the implementation of the licence requirements.
An assessment is made of the location where the veterinary medicinal products are stored and/or delivered. (This applies only to a wholesale and retail licence.)
When applying for a production licence (manufacture and/or importation), a GMP inspection is scheduled in consultation with the Health and Youth Care Inspectorate (in formation), whereby the production location is assessed on the basis of current GMP requirements. A licence can be refused if you do not comply with the licence requirements.
The costs for handling the application/amendment of a licence are stated under Production and distribution licence fees.
In addition, an annual fee applies to all licences.
Granting a production licence
Before a production licence can be issued, a GMP inspection must be carried out. During a GMP inspection, which is carried out by the Health and Youth Care Inspectorate (in formation) (hereinafter IGJ), in collaboration with the MEB Agency, Veterinary Medicinal Products Unit (hereinafter VMPU), it is determined whether the production site complies with current GMP requirements and for which activities a production licence can be granted.
After receiving your application for a production licence (manufacture and/or importation), the GMP inspection is scheduled by the IGJ, at the request of the VMPU. This GMP inspection usually takes the entire day, depending on the size of the production site.
More information on GMP requirements, the GMP inspection and issuing a GMP certificate.
The production licence is issued by the VMPU after the assessment (during the GMP inspection) and approval of the activities by the IGJ. This licence contains the decree as well as an annex that lists the (outsourced) production activities (manufacture/importation), among other things. It also contains a list of veterinary medicinal products that may be manufactured and/or imported based on the licence.
After having been granted a production licence, you will be listed as a licence holder in the licence register on our website.
The production licence and the accompanying GMP certificate are also listed in the European database called EudraGMP.
Granting a distribution licence
During an on-site assessment, the extent to which you, as an applicant, meet the required licence requirements will be examined. During the on-site assessment, any shortcomings observed are discussed with you.
Depending on the shortcomings as observed during the on-site assessment, you will be informed via an inspection report whether the licence requirements have been met and whether the requested licence will be granted.
The inspection report will be sent to you digitally within 4 weeks. If the requirements are met, the licence will be sent to you via a decree. In addition, you will be listed as a licence holder in the licence register.
If the requirements are not met, you will have the opportunity to take additional measures on the shortcomings observed and to respond by e-mail within 4 weeks.
After receiving your written response, an assessment will be made as to whether the submitted data and the measures described are sufficient for granting the licence.
You will only receive a licence if the measures are assessed as satisfactory. In addition, you will be listed as a licence holder in the licence register on our website.
Licences are issued for an indefinite period, in which an annual fee must be paid.