The Committee for the Authorisation of Veterinary Medicines (in Dutch: 'Commissie toelating diergeneesmiddelen', Ctd) issues recommendations on whether to grant marketing authorisations for veterinary medicines. The Ctd also advises on whether veterinary medicines should be made available on medical prescription only, and on the legal status of supply for these medicines. In its recommendations, the Ctd always weighs up the therapeutic effects in target animal species and possible harmful side effects of medicines on animals, humans or the environment. The Ctd has been set up by the Ministry of Agriculture, Nature and Food Quality (LNV).
The Ctd is assisted in its duties by the Veterinary Medicinal Products Unit (BD). Where necessary, the BD requests an independent, expert opinion from the Ctd. Recommendations from the Ctd to the BD concerns matters such as:
- granting a new marketing authorisation for a veterinary medicine;
- the amendment, suspension or withdrawal of existing marketing authorisations;
- pharmacovigilance;
- prescription-only status, legal status of supply, package leaflets, packaging or labelling.
Subsequently, the BD issues (or does not issue) the marketing authorisation.
Composition and working procedure of the Ctd
The Ctd has a maximum of seven members, including the chair. The members are medical specialists, pharmacists and other experts. The chair and members are appointed by the Ministry of Agriculture, Nature and Food Quality. The selection process for the appointment of Ctd members always takes into account what is required to safeguard the expertise in the Ctd on the 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 has meetings once a month. These meetings, which are also attended by BD representatives, are conducted by means of a fixed working procedure. In these meetings, the BD reports to the Ctd on the finalised decisions and on the results of pharmacovigilance. The Ctd advises on questions arising from the BD’s assessment of applications for new marketing authorisations and for amendments to existing marketing authorisations. In addition, various other matters are addressed, such as unexpected effects that sometimes occur in practice when veterinary medicines are administered.