Veterinary Medicinal Products Regulation: update no. 1
The new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Regulation (EU) 2019/4 relating to medicated feed are both coming into effect on 28 January 2022. A great deal will change as from next year primarily 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.
What are the most important changes as a result of the VMR?
The implementation of the VMR will result in many changes. The following is a summary of a few of these future changes:
There will be several new databases:
- The Union Product Database (UPD)
- The pharmacovigilance database
- The Manufacturers and Wholesale Distributors database (EudraGMDP) for the manufacture, import, wholesale of veterinary medicinal products and the trade in active pharmaceutical ingredients (APIs).
The Good Distribution Practices (GDP) will become applicable to veterinary medicinal products and active pharmaceutical ingredients. A GDP inspection/certificate will also be linked to wholesale licences.
The procedures relating to the authorisation and amendment of marketing authorisations are to change in the number of ways. It will no longer be necessary to renew marketing authorisations. They will continue to apply on the condition that no issues occur with regard to the safety of people, animals and the environment. Another important change is that administrative modifications will be classified as changes for which no assessment is required. These modifications will be implemented in the UPD by the marketing authorisation holders themselves.
Changes will also be introduced for veterinary medicinal products for use in connection with cage birds, aquarium fish, carrier pigeons, terrarium animals, small rodents, ferrets and rabbits (not consumption), which are still exempt from registration. Data pertaining to the use of veterinary medicinal products will have to be entered into the UPD.
The rules governing pharmacovigilance are to be thoroughly revised. The PSURs will no longer be used and will be replaced by Signal Detection in the EMA's pharmacovigilance database. Each marketing authorisation holder must also have a Pharmacovigilance System Master File (PSMF) containing a description of the pharmacovigilance system and the processes. The pharmacovigilance inspection will take place at the location of the PSMF.
The VMR contains new rules regarding autogenous vaccines, the parallel trade of veterinary medicinal products and clinical animal tests.
The supply status of identical products will be the same within the entire EU (POM/NON-POM). In the case of an established POM (Prescription Only Medicine) supply status, the further subcategorisation of the legal status of supply into UDD, URA and UDA will, however, be determined at national level.
The rules regarding the use of antibiotics are to be tightened even more and harmonised in the EU. For example, the data relating to the sale and use of antibiotics is to be collected by the Member States. The Member States will then forward this information to the EMA and the EMA will report accordingly.
How will the further detailing of the VMR take place?
The further detailing of the VMR will take place in the so-called delegated en implementing acts that are being drawn up by the European Commission. The majority of delegated and implementing regulations have not yet been completed. Currently, therefore, not everything is entirely clear at the moment. However, Implementing Regulation (EU) 2021/17 relating to the variations for which no assessment is required and Implementing Regulation (EU) 2021/16 relating to the Union database on veterinary medicinal products have been adopted. The other delegated and implementing regulations will be adopted later this year, while a number will only be adopted in 2022 or later.
What consequences will the VMR have for existing guidance documents?
After all delegated and implementing regulations have been adopted and clarity has been provided with regard to the exact changes that will take place, the existing European guidance documents and procedures will have to be amended. You should therefore keep an eye on the websites of, among others, the European Commission, the EMA - with regard to the VMR, the CMDv and the Notice to Applicants. Every two months the EMA publishes a newsletter relating to the VMR that you can also subscribe to.
What consequences will the VMR have for national legislation?
The VMR is a regulation with direct effect and is therefore binding for all Member States. There is no room for any national interpretation of the veterinary medicinal products legislation, except where this is explicitly stated in the VMR. This means that the Animals Act [Wet dieren] and all relevant decisions and regulations, such as the Veterinary Medicinal Products Regulation [Regeling Diergeneesmiddelen] and the Veterinary Medicinal Products Decree [Besluit Diergeneesmiddelen] have to be amended. The revised Animals Act is currently being debated in the Dutch House of Representatives [Tweede Kamer]. The Ministry of Agriculture, Nature and Food Quality [Ministerie van LNV] is responsible for policy in this regard..
How can you stay up to date on developments?
During the coming year the Veterinary Medicinal Products Unit will give notice of important new developments resulting from the VMR changes on the website and via news reports. These news reports will also explain certain themes in the VMR, such as a theme-based news report that is dedicated to pharmacovigilance changes. You can subscribe to these news reports via the 'Subscribe to veterinary medicinal product documents' link.
In addition to this a lot will change in the documents of the Veterinary Medicinal Products Unit, particularly next year, because the changes that result from the VMR must be implemented in existing documents. You can also subscribe to updates of new documents via the 'Subscribe to veterinary medicinal product documents' link.
The Veterinary Medicinal Products Unit is also going to organise one or more information meetings, together with the Ministry of LNV. Additional information on this will be provided at a later date.
You can always submit any questions you have to the Veterinary Medicinal Products Unit via the 'Submit your question to the MEB' link.
