Purpose
The purpose of this notice is to inform key stakeholders of the actions they will need to undertake to continue to submit regulatory and notification information to the UK, via the Veterinary Medicines Directorate (VMD), in the event that the UK leaves the EU in March 2019 with no agreement in place.
Before 29 March 2019 (may also apply to new exit date on 31 December 2020)
Under the current EU membership, the UK is integrated in European regulatory networks for veterinary medicines. These regulatory networks have, over time, developed shared processes and systems. Several regulatory activities make use of common methods for submitting and exchanging information throughout the Union. These common systems, in the case of veterinary medicinal products, include, but are not limited to:
- Common European Submission Portal (CESP)
- Gateway (Pharmacovigilance)
- EudraLink
- WebTrader (Pharmacovigilance)
After March 2019 if there’s no deal
In the unlikely event that the UK leaves the EU in March 2019 with no agreement in place regarding future arrangements, the UK would no longer be part of EU veterinary medicine regulatory networks. The sharing of common systems, and exchange and recognition of data submitted for regulatory activities, between the UK and EU Member States would cease.
The VMD would have independent processes and systems to manage UK veterinary medicines and regulatory activities end-to-end. To enable this, new systems will be in place ready for March 2019.
Implications
After exit, regulatory information relating to veterinary medicines would need to be submitted and processed via separate routes for the EU and UK. The VMD would provide a service to allow for the submission and exchange of information for veterinary medicine activities, including, but not limited to, the following types of submissions:
- Marketing Authorisation (MA) Applications
- Periodic Safety Update Reports
- Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance System notifications
Applications to both the EU and the UK would require submission of application dossiers through EU channels as well as submitting directly to the UK. In addition the VMD would ensure suitable solutions are in place to facilitate the submission and sharing of pharmacovigilance reports and data.
The VMD aims to adhere to the following principles in developing independent processes and systems for regulatory activities:
- Minimise impact where possible. For example: VMD would continue to accept EU standards for submission of data; The current electronic format, VNeeS, would still be the underlying format required for submission of regulatory documents related to a Marketing Authorisation (MA), with the exception of Active Substance Master Files (ASMFs), which can be in either VNeeS or e-CTD format.
- Avoid unnecessary complexity, for example by replicating established processes.
- Ensure systems are available for March 2019, with these then being further developed over time.
Development of new solutions
In advance of leaving the EU, the VMD will provide suitable communications and guidance to stakeholders to inform them of new processes and systems. We are planning for this to be provided later this year. It is our intention that where these systems are outward facing there will be some stakeholder testing; where required, training will also be provided.
If stakeholders need to modify their own systems to allow direct exchange with new VMD systems, we aim to provide notice and support to enable the implementation of any connections later this year.
Industry interaction with the EU
UK industry should be able to continue interacting with the EU regulatory network as per EMA and EU guidance.
More information
Please see the other two technical notices relating to the regulation and registration of veterinary medicines for further information, and the information stated within this technical notice is subject to matters addressed in other technical notices.
This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.
It is part of the government’s ongoing programme of planning for all possible outcomes. We expect to negotiate a successful deal with the EU.
Norway, Iceland and Liechtenstein are party to the Agreement on the European Economic Area and participate in other EU arrangements. As such, in many areas, these countries adopt EU rules. Where this is the case, these technical notices may also apply to them, and EEA businesses and citizens should consider whether they need to take any steps to prepare for a ‘no deal’ scenario.
