Guidance for the Pharmaceutical Industry on How to Apply for and Manage an Authorisation to Place a Veterinary Medicine on the UK Market Post Transition Period

From 1 January 2021 the fees listed in the Veterinary Medicines Regulations will continue to apply for each GB Marketing Authorisation (MAs), NI MA and existing UK wide MA. If your existing UK MA meets EU Regulations on 1 January 2021, you will be able to market your product in GB and NI in existing packaging.

Products authorised via the Mutual Recognition (MRP) or Decentralised (DCP) procedures were issued with national UK MAs. On 1 January 2021, your MA will continue to be valid UK wide, subject to the UK and EU operating an equivalent regulatory framework. There are likely to be actions you must take to ensure your packaging includes information relevant to UK Regulations. Once you have approval for your mock-ups you will have up to 6 months to implement the new packaging.

Your existing MA issued by the EMA will continue in place in NI. We can automatically provide you with an MA valid in GB after 1 January 2021.

Existing Generic products authorised prior to 31 December 2020, which cite a European reference product may remain on the market. As the data exchange facility between the UK and the EU will no longer exist, you must provide us with any data needed to develop your MA for future variations.

Centralised applications will continue in accordance with the EU timetable. For new MA applications, if the outcome is favourable and UK and EU opinions are aligned, you will be issued with an MA by the EMA valid in NI and a GB MA. Your centralised application will be determined by the EMA in accordance with the EU Regulations.

To access the GB market, it will be possible to run the MRP/DCP and national procedures on parallel timetables. New Centralised MA Centrally authorised products are valid in all member states and will include NI. These are issued by the EMA and subject to EU Regulations.

You can submit applications for a new GB MA and a new NI MA in parallel to facilitate UK wide coverage. You must submit your EU application through CESP (DCP) or via the Common Repository (CAP) Within 2 working days at the latest, submit the GB MA application to the VMD via the Veterinary Medicines Digital Service (VMDS)

Both variants must be included in the dossier submitted in support of the GB MA application. You must submit your applications to the EU and then, within 2 working days at the latest, submit the GB, NI and/or UK wide MA applications to the VMD via the VMDS.

Centrally authorised products will only be valid in NI and will continue to display the EU MA number. Joint labelling with Ireland will continue to be possible by displaying both the EU MA number and the GB Vm number on your packaging.

If the UK and EU opinions are not aligned it may not be possible to maintain an MA valid UK wide. If the UK opinion is not favourable contrary to the EU, it may not be possible for the MA to remain valid in GB. Equally if the UK opinion is favourable contrary to the EU it may be possible for the MA to remain valid in GB only.

The onus is on you to maintain your existing UK wide MA. Separate your MA to 1 GB MA (subject to UK Regulations) and 1 NI MA (subject to EU Regulations)

Failure to submit a duplicate application to either us or the EU could result in MA separation. Upon separation, your new GB and NI MAs will be issued with a new Vm number for each. The data and documents required in support of an application remain unchanged. The current EU and CVMP guidelines will continue to be used until we establish our own guidance.

To maintain alignment between NI and GB MAs you must submit your applications to the EU authority and VMD in parallel. For GB MAs you must prove that the product to be imported is identical or therapeutically equivalent to the UK authorised product. For NI MAs the MAPI procedure will continue as it does now, and we will be able to seek the required information from member states.

You should receive the GB and EU list of questions at a similar time. Running a procedure in parallel could: enable you to have a single project team working on both applications. Running submissions in parallel does provide the opportunity to take into consideration the EU position.

We have the authority and procedures in the UK for reviewing products and requesting changes. Existing MAs valid UK wide authorised through EU procedures remain subject to EU Referral procedures.

Source: MHRA guideline on Guidance for the pharmaceutical industry on how to apply for and manage an authorisation to place a veterinary medicine on the UK market post transition period.