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.
If you have any further questions, please contact the Veterinary Medicinal Products Unit.
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