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.
You apply for a licence or a change to the licence via the following application forms:
- (first) application for a licence
- change to an existing licence
The application form, including the annexes it mentions, must be completed and returned to: email@example.com.
The application is processed digitally and you will receive a confirmation of receipt which includes an accompanying case number. In any further correspondence, please always include the case number in the subject line of the e-mail.
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.
In consultation with you, an assessment is made of the location (company visit) where you intend to manufacture, import, store and/or deliver veterinary medicinal products.
A licence can be refused if you do not comply with the licence requirements.
The costs for processing the application/change are listed under Production and distribution licence fees. In addition, an annual fee applies to all licences.
Granting a production and/or distribution licence
During an company visit, an assessment is made of the extent to which you, as an applicant, comply with the licensing requirements. During the company visit, any shortcomings observed are discussed with you.
Depending on the shortcomings as observed during the company visit, an inspection report will state whether the licensing requirements have been met and whether the requested licence will be granted.
The report will be sent to you digitally within 1-4 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 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.
Change request for production or distribution licences
A change request is needed if the situation - as mentioned in the previously issued licence - has changed. For example, with regard to:
- the location where veterinary medicinal products are prepared, packaged, labelled, stored or delivered
- the name of the natural or legal person to whom the licence has been granted
- the activities (preparation, delivery, manufacturing, import, wholesale or retail)
- change of 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).
Withdrawing the licence
As a holder of a licence for the manufacture, importation, wholesale and/or retail trade, you can decide to withdraw the licence.
You can send withdrawal requests by e-mail to: firstname.lastname@example.org.
The request is processed digitally and you will receive a confirmation of receipt which includes an accompanying case number.
A withdrawal request must have been received by the Veterinary Medicinal Products Unit by no later than 30 November.
If your withdrawal request is received later, it may not have been dealt with before the end of the year. In that case you may have to pay the annual fee for the subsequent year.
Licensing requirements for pharmacists or veterinarians
Trade in veterinary medicinal products without a licence is prohibited (Article 2.19 of the Animals Act).
A pharmacist who is in charge of a pharmacy and registered in the BIG register of established pharmacists provided by the Public Health Supervisory Service is legally licensed for retail trade (Art. 5.4 of the Veterinary Medicinal Products Decree).
A veterinarian legally has a retail licence to supply veterinary medicinal products to keepers of animals for animals for which the veterinarian provides medical care as part of the execution of his profession (Art. 5.5, section 1 of the Veterinary Medicinal Products Decree).
If the activities exclusively fall under the concept of retail trade (delivery to animal holders), a pharmacist or veterinarian need not apply for a licence.
If a veterinarian or pharmacist delivers veterinary medicinal products to others than keepers of animals, an application for a wholesale trade licence in veterinary medicinal products must be made.
Veterinarians and pharmacists who legally have a retail licence are not listed in the licence register.