Mitigations for Veterinary Medicine Regulations
The EU regulation 2019/6 will apply in the EU from January 28, 2022. As part of the EU, we actively helped to develop and negotiate the regulation and therefore agree to a lot of its content.
The GB VMR is currently under review and is subject to a formal public consultation. Until the revised GB-VMR comes into force, there will be a so-called “air gap” between the two legal provisions for the EU (NI) and GB.
We understand that industry is focused on serving the region of Europe, which NI is a part of, and its regulatory requirements. As a preliminary measure, we have considered areas where we can fill this gap between EU legislation and the current VMR as it affects the UK while respecting both laws to ease the burden on the industry and the to facilitate continuous availability of veterinary medicines in NI and GB.
IMPORTANT: This is a preliminary measure and does not prejudice or prejudice the outcome of the formal consultation on the GB VMR as we will take into account the views of a wide range of stakeholders.
The mitigation measures considered and described below are based on feedback from industry on areas of greatest concern and pollution. More more detailed instructions will be made available as soon as they are finished.
From January 28, 2022 we will follow the new variation regime:
- for variants not subject to assessment: similar to current type IA
- for changes requiring assessment: These are taken into account on the basis of sub-categories, e.g. B. reduced timetable similar to type IB and standard / extended timetable similar to type II or extension
In EU proceedings, the reference member state (RMS) manages the process and NI is an affected member state (CMS). We will continue to allow parallel filings for assessable changes in both NI and UK, and if it is an EU process we will stick to the EU timeline. This is to help maintain alignment of GB and NI MAs.
For national changes that are not subject to assessment or modifications that are subject to assessment, you must submit a simple application via the VMDS.
EU regulations remove the requirement to file an extension to rely more on pharmacovigilance and signal detection. We still require the submission of renewal requests and the charging of a fee, but with a greatly reduced data package. We will process the application administratively, whereby the resulting employee documentation has an unlimited lifespan.
This means that from January 1, 2022, you will no longer have to fill out comprehensive accompanying documents and there will be no evaluation that could lead to possible deviations in multi-country packaging.
Further details on the reduced data requirements will be published in due course.
Applications that have already been submitted will continue to be checked, as this reduction will not be applied retrospectively.
There are significant changes to the pharmacovigilance requirements in the EU Regulations 2019/6. Above all, the change from Periodic Safety Update Reports (PSURs) to a stronger dependency on signal detection and the change from submitting the DDPS with every market approval in favor of a master file approach.
We will publish further guidance on the following reductions in due course.
Reporting of adverse events
Starting January 1, 2022, Marketing Authorization Holders will still have to submit all Serious Adverse Events within 15 days (as is currently the case), but will have the option to submit all other Adverse Events electronically within 30 days.
Marketing Authorization Holders are not required to provide accelerated and / or routine third country reports for products also authorized in the UK, but we reserve the right to use them for risk-benefit assessments if necessary -Ratio of a product to request.
Causality checks are no longer required.
Regular security update reports
Marketing Authorization Holders are still required to submit PSURs under the current UK VMR. However, the guidance on the content of these reports will be updated to allow MAHs to provide the VMD with similar information that they would provide to the EU.
For products with a three-year reporting cycle, the revised guidance will allow MAHs to voluntarily submit PSURs annually to align with their submissions to the EU. Similarly, the current VMR for individuals with a 6 month cycle allows Marketing Authorization Holders to request a change in the frequency of submissions which could be used to move it to an annual one.
Detailed description of the pharmacovigilance system (VBS)
Marketing Authorization Holders can choose to proceed with the current VBS requirements or provide a Pharmacovigilance System Summary (PSMF) instead.
We will enable Marketing Authorization Holders to switch from their VBS to PSMF without having to submit changes.
If, for any reason, you submit a request for a change to a Marketing Authorization Holder with a VBS, we will examine whether we can charge a reduced fee for all changes instead of a flat fee for each product. This will be checked on a case-by-case basis.
Applications for a new marketing authorization in NI on or after January 28th can use the EU QRD template (labeling text) version 9.
UK Marketing Authorization Applications on or after January 28th will use an updated QRD template. This contains information that is required in version 9, but also any missing national specific requirements, as stated in the VMR.
We will update our guidance pages in due course with the appropriate templates to be used from January 28th.
Applications submitted prior to January 28th must still conform to the current national QRD template.