The Veterinary Medicinal Products Unit is the veterinary branch of the MEB. The Veterinary Medicinal Products Unit operates on behalf of the Minister of Agriculture, Nature and Food Quality, who is the official competent authority.
Tasks of the Veterinary Medicinal Products Unit
The Veterinary Medicinal Products Unit is the executive institution that is responsible for the following tasks, among others:
- the assessment of applications for and the issuing and maintenance of marketing authorisations for veterinary medicines (also including vaccines and homoeopathic veterinary medicines);
- the assessment of applications for and the issuing and maintenance of registration of all active substances used as a starting material for a veterinary medicine;
- monitoring of veterinary medicines (pharmacovigilance) and pharmacovigilance inspections;
- issuing of authorisations to manufacturers (including GMP certification), importers, wholesalers (including GDP certification) and retailers of veterinary medicines;
- issuing of:
- batch approvals for immunological veterinary medicines;
- export certificates;
- testing exemptions for veterinary medicines and animal feed additives;
- providing advice to bodies such as the Ministry of Agriculture, Nature and Food Quality, the Netherlands Food and Consumer Product Safety Authority, the Inspectorate for Health and Youth Care, Dutch Customs and Excise, and stakeholders;
- assessment of product defects and recalls;
- determining Y/N status for veterinary medicines;
- providing support and advice in the field of animal feed additives and animal feed claims.
Employees of the Veterinary Medicinal Products Unit are represented on a variety of national and European task forces such as the Co-ordination Group for Mutual Recognition and Decentralised procedures - Veterinary (CMDv), the Committee for Medicinal Products for Veterinary Use (CVMP) and various task forces within the CMDv and CVMP.
Report, advice and assessment
The Veterinary Medicinal Products Unit compiles reports into applications submitted to the Committee for the Authorisation of Veterinary Medicines (Ctd) for marketing authorisations for veterinary medicines. This does not apply to applications via the central procedure.
The Ctd then issues a recommendation to the Ministry of Agriculture, Nature and Food Quality (LNV) regarding whether to grant the marketing authorisation. In consultation with the Minister of Health, Welfare and Sport, the Minister of Agriculture, Nature and Food Quality then decides whether or not to issue the marketing authorisation. Subsequently, the Veterinary Medicinal Products Unit issues (or does not issue) the marketing authorisation.
More information
If you have any further questions, please contact the Veterinary Medicinal Products Unit.
News
Important news is published by the Veterinary Medicinal Products Unit on the website or via news items on the website. You can subscribe to these News items via Subscribe to news from Veterinary medicines. In addition, you can also subscribe to updates of new documents via Subscribe to documents from Veterinary medicines.
In addition to the information channels mentioned above, the Veterinary Medicinal Products Unit also occasionally sends information e-mails with short practical information. We only do this if there is reason to do so and if we want to inform you quickly about a subject that we think that it may be of interest to you.
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