Amendment of letters and decisions by the Veterinary Medicinal Products Unit
The Veterinary Medicinal Products Unit of the MEB Agency will soon implement changes to the letters and decisions pertaining to the release of marketing authorisations, based on the current legislation and regulations.
The most important changes are the replacement of the terms “beschikking” (judgement) and “registratie” (registration). These will change to: “besluit” (decision) and “handelsvergunning” (marketing authorisation). This is described in the conditions of the Animals Act, the Decree and the Regulation on veterinary medicinal products.
All marketing authorisations will be recorded in the register as defined in article 7.2, section one of the Animals Act. The requirements as listed in the Summary of Product Characteristics (SmPC) apply to all marketing authorisations. These will be added to the decision as Appendix I. The amended labelling and package leaflet texts will be added to the decision as Appendix II.
In future, the decree will also mention that the marketing authorisation shall only come into force officially on the date on which the decision is announced in the Government Gazette.
If you have any questions, please contact the Veterinary Medicinal Products Unit.