The Veterinary Medicines Directorate VMD is the UK competent authority which conducts regulatory and pharmacovigilance functions for the Great Britain (GB) and also for Northern Ireland (NI). The protocol for Northern Ireland has been applied since the beginning of 2021. For veterinary medicinal products, this meant that any UK MA under MRP/DCP/CP was converted to a GB MA for the GB market, but NI MA could still remain as part of the EU procedure. How this has affected veterinary medicinal products is further explained here.
The Veterinary Medicines Digital Service VMDS functions as a portal for submitting applications, variations, documentation for the national processes (GB and NI), adverse events and periodic safety update reports (PSURs). It has replaced the EU systems from 1 January 2021. A NI MA under CP or MRP/DCP can still be submitted via the EMA eSubmission Gateway or CESP. With this in mind, there are some important aspects worth considering in regulatory submissions in the post-Brexit world:
- The choice of submission route depends on the relationship between the GB and NI processes (see more information on submission routes).
- When you have a GB national MA and a NI MA from MRP/DCP/CP, the VNeeS must also be submitted via the VMDS within two working days to keep the assessment of variation in parallel.
- The application forms for the UK national procedures are available via VMDS and will have to be submitted with the application.
Similarly, Safety submissions after Brexit are done as follows:
- Adverse events occurring in NI are reported to the Union Safety Database (EVV) which will forward the cases to the UKVMD.
- Adverse events occurring in the UK shall be submitted both to the UKVMD and EVV.
- Third country reports will no longer be submitted to the UKVMD.
- PSURs are still submitted to the VMD to the address PSUR.firstname.lastname@example.org. The PSUR checklist template provided by the VMD is an optional template to help with PSUR formation. It provides a simple framework for the report, detailing all the information which should be included in a PSUR.
The VMDS portal can also be used by consultants or CRO companies on behalf of the applicant, MAH or ASMF holder by invitation from the company. The service will recognise consultants, which enables giving access only to the relevant information and parts of the service.
The GB Veterinary Medicines Regulation (VMR) is still under review, as regards the impact of the new EU veterinary regulation. Until the revised GB VMR comes into force, there will be an “airgap” between legislation covering the EU (NI) and GB to reduce burden to the industry. The latest developments and details can be followed on the VMD Information Hub site.
If you need any assistance, contact us.