The Committee on the authorisation of veterinary medicinal products (Ctd) advises on marketing authorisation, prescription requirements and the legal status of supply of veterinary medicinal products. In advising, the committee always considers beneficial effects in target animal species and possible adverse effects of medicinal products on animals, humans and the environment. The Ctd has been established by the Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN).
The Committee on the authorisation of veterinary medicinal products (in Dutch: Ctd, Commissie toelating diergeneesmiddelen) is supported by the Veterinary Medicinal Products Unit (BD). Where necessary, the BD requests an independent, expert opinion from the Ctd. Advice by the Ctd concerns matters such as:
- granting a new marketing authorisation for a veterinary medicinal product;
- the amendment, suspension or withdrawal of an existing marketing authorisation;
- pharmacovigilance;
- prescription requirements, legal status of supply, product information leaflets, packaging or labelling.
Composition and procedures of the Ctd
The Ctd consists of seven members, including the chair. The members are veterinary medical specialists, pharmacists and other experts. They are appointed by the Minister of Agriculture, Fisheries, Food Security and Nature. When new members are appointed, particular attention is given to what is required to maintain a balanced level of expertise on various aspects of veterinary medicines. This concerns aspects like the composition, administration, efficacy and side effects of veterinary medicines, the various categories of target animal species and pathogens and (eco)toxicology.
The Ctd meets once a month together with representatives of the BD, following a fixed procedure. During these meetings, the BD informs the Ctd on questions arising from the BD’s assessment of applications for and amendments to marketing authorisations, as well as on unexpected effects that occassionaly occur when veterinary medicinal products are applied in practice. In addition, the BD reports to the Ctd on finalised decisions and on the results of pharmacovigilance.