Veterinary Medicinal Products Regulation: update no. 2
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.
The following are a few updates on the latest developments in the field of the VMR.
Delegated and implementing regulations
The further detailing of the VMR will take place in the form of delegated and implementing regulations, which are being drawn up by the European Commission. The following delegated and implementing regulations have now been adopted:
The other regulations are to be adopted later this year, with a number only being adopted in 2022 or later.
Guidelines: public consultations and implementation guide
Currently a large number of European guidelines are being submitted for public consultation and the majority have not yet been laid down. You should therefore continue to 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.
Union Product Database (UPD)
The guidelines for marketing authorisation holders and government bodies for the uploading of data into the new Union Product Database have now been laid down in the Implementation guide (versie 1). The implementation guide deals with issues such as the process, the timelines, the requirements, the technical specifications and the rules for submitting data.
Change to parallel trade requirements
Parallel trade is a new concept in the Veterinary Medicinal Products Regulation and is currently still referred to as parallel import. The rules for parallel import are being aligned within Europe and the requirements will change in a number of ways. A Best Practice Guide will be introduced that will clarify the requirements, as well as a European application form. In the case of the parallel trade in veterinary medicinal products the wholesaler will ensure that the veterinary medicinal product that it wants to import from a Member State and distribute in another Member State is the same as the veterinary medicinal product permitted in the destination Member State. This means that they have the same:
- qualitative and quantitative composition of active substances and excipients;
- pharmaceutical form;
- clinical information, and (if applicable) waiting time;
- manufacturer or have been manufactured in accordance with the same formula by a manufacturer operating under a licence.
In the case of parallel import marketing authorisations that have already been issued and that do not fulfil these conditions, the European Commission still has to determine when these new requirements will come into effect.
Legal status of supply aligned in EU
Based on Article 34 of the VMR the legal classification of identical products is to be aligned throughout the EU. This article also lays down the requirements for the classification of Prescription Only Medicines (POM) and Non-Prescription Only Medicines (NON-POM) for veterinary use. In the case of an established POM (Prescription Only Medicine) classification, the further subcategorisation of the supply and the usage authorisations - which are currently expressed in the UDD, URA and UDA legal statuses of supply - will, however, be determined at national level.
The European Commission recently clarified that this harmonisation of the POM/NON-POM classification (Article 34) must be completed by 28 January 2022. This means that the supply status and usage authorisations (legal status of supply) must also be known by then. However, the European Commission is currently reconsidering this decision. The exact date is, therefore, not yet known at the moment but you should bear in mind that it could be 28 January 2022.
The first step is that a European framework will be drawn up against which the individual veterinary medicinal products can be assessed in terms of POM/NON-POM. This assessment must then show whether the national legal status of supply has to be changed.
After this phase has been completed the following step will be for decisions to be issued on the changed legal status of supply for all veterinary medicinal products with regard to which the legal status of supply has to be changed.
Pharmacovigilance rules to be revised
In the field of pharmacovigilance the PSURs will no longer be used and will be replaced by Signal Detection in the EMA's pharmacovigilance database. As of 28 January 2022 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 EMA has drawn up a ‘Scientific recommendation regarding the PSMF’ that, in all probability, will be added to in due course.
Permission for small packaging of antimicrobial veterinary medicinal products to be scrapped
The 'Permission for small packaging of antimicrobial veterinary medicinal products' [Toestemming kleinverpakkingen antimicrobiële diergeneesmiddelen] is to be scrapped under the VMR. Instead, a marketing authorisation will have to be applied for under the VMR for these antimicrobial veterinary medicinal products, as from an as yet unknown date. It may be possible to submit an application for a limited markets for these veterinary medicinal products (Article 23). In order to be able to submit an application for limited markets, the application and the dossier will have to fulfil specific requirements.