The new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Regulation (EU) 2019/4 on medicated feed are both coming into effect on 28 January 2022. A great deal will change as from next year due to the implementation of the Veterinary Medicinal Products Regulation (VMR). The development and further detailing of the Veterinary Medicinal Products Regulation have been in progress since its publication in January 2019.
The regulation's most important objectives are:
- to make the legislation easier and to reduce administrative burdens for pharmaceutical companies that develop veterinary medicinal products
- to encourage the development of innovative veterinary medicinal products including, for example, products for small markets
- to improve the operation of the internal market for veterinary medicinal products
- to strengthen EU initiatives to combat antimicrobial resistance through measures to ensure the proper use of antimicrobial substances in animals.
The Veterinary Medicinal Products Regulation is to be developed in delegated and implementing regulations, which are being drawn up by the European Commission.
Binding rules for all Member States
The Veterinary Medicinal Products Regulation is binding for all Member States. There is no room for any national interpretation of the veterinary medicinal products legislation except where this is stated in the VMR, or if the VMR does not regulate a particular issue. This means that the Animals Act [Wet dieren] and all relevant decrees and regulations have to be amended, for example the Veterinary Medicinal Products Regulations [Regeling Diergeneesmiddelen] and the Veterinary Medicinal Products Decree [Besluit Diergeneesmiddelen]. The texts that are necessary for those issues that have to be interpreted at national level have been included between brackets in the new version of the Animals Act. The amendment to the Animals Act that is necessary in order to implement the regulations at national level has now been adopted by the Dutch House of Representatives and Senate and published in the Bulletin of Acts, Orders and Decrees [Staatsblad]. The Ministry of Agriculture, Nature and Food Quality [Ministerie van Landbouw, Natuur en Voedselkwaliteit] is responsible for policy in this regard.
This ministry is currently composing the new Veterinary Medicinal Products Decree, which will be coordinated with the relevant stakeholders in due course. It tackles issues that the VMR permits, or to which the VMR is not applicable, but still have to be regulated at national level. The new Veterinary Medicinal Products Decree will be compiled without any policy changes, meaning that it will not include any new policy, but that current policy will be continued. The new Veterinary Medicinal Products Regulations are also being drawn up at the moment, based on the new Veterinary Medicinal Products Decree.
Online information meetings (in Dutch)
In the coming months we are organising a number of online information meetings to inform you of the most important changes that will take place due to the implementation of the Veterinary Medicinal Products Regulation. During these meetings you will be able to ask questions about the changes. The first meeting was held in the afternoon of Tuesday 28 September 2021.
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