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Detailed guide: From 1 January 2021 Application and Authorisation Process explainer

Veterinary Medicines Directorate

November 23
17:14 2020

Marketing Authorisation Regulation

The Northern Ireland Protocol provides for products authorised in Northern Ireland (NI) to remain subject to EU Regulations.

We have listened to your feedback and in order to minimise disruption, until January 2023 we will continue to recognise:

  • Marketing Authorisation Holder location: this means we will continue to accept MAHs located in an EU member state for existing and new UK marketing authorisations for this time period

  • Manufacturing: for the same period, we will continue to accept EU member state locations for: manufacturing sites, Qualified Persons (QPs); site of product batch testing, and site of QP certification/release

Application Fees (updated 23/10/20)

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.

As we operate on a cost recovery basis, fees are charged in order to cover the work undertaken by the VMD. The respective sets of legislation will reflect the fees payable, but in cases where parallel submissions are made, then one or more of the fees for NI and GB applications will be administratively reduced.

The reduced fee will take account of the additional administrative activities we will need to perform for each MA or product. More information about these fees will be available soon.

Existing Marketing Authorisations granted prior to 31 December 2020 (updated 23/10/20)

National UK Marketing Authorisations

From 1 January 2021, your existing UK MAs, which have no EU involvement, will continue to be valid UK wide, subject to the UK and EU operating an equivalent regulatory framework and opinions align.

To continue to market these products in NI, your MA must meet EU Regulations by 1 January 2021. If you choose not to observe EU Regulations, we will replace your existing MA with an MA which will be subject to UK Regulations and cannot be marketed in NI

This means that 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, as you do now. If your MAs meet only UK Regulations, then you can only market your product in GB under your new GB MA.

We will update this section with more information as it becomes available.

Existing Mutually Recognised and Decentralised Products (updated 23/11/20)

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 and opinions align.

These products may remain on the UK market in existing packaging which meets EU Regulations. There are likely to be actions you must take to ensure your packaging includes information relevant to UK Regulations and variation applications must be submitted by 1 January 2023. Once you have approval for your mock-ups you will have up to 6 months to implement the new packaging. Products which have been QP released and on the market before the new packaging implementation date may remain for sale and supply in their existing packaging.

We are working to keep changes to a minimum and will provide all the information you need in good time.

This means that you will be able to place products on the UK market as you do now, until your new packaging implementation date.

We will update this section with more information as it becomes available.

Existing Centrally Authorised Products (updated 23/11/20)

From 1 January 2021, NI will be included within the scope of the Centralised procedure. Your existing MA issued by the EMA will continue in place in NI and remains subject to EU Regulations.

We can automatically provide you with an MA valid in GB after 1 January 2021, subject to UK Regulations. See Centrally authorised product conversion for more information.

These products may remain on the UK market for sale and supply in existing packaging that meets EU Regulations, subject to the UK and EU operating an equivalent regulatory framework and opinions align. There are likely to be actions that you must take to ensure your packaging includes information relevant to UK Regulations and variation applications must be submitted by 1 January 2023. Once you have approval for your mock-ups you will have up to 6 months to implement the new packaging. Products which have been QP released and on the market before the new packaging implementation date may remain for sale and supply in their existing packaging.

This means that you can continue to place products on to the UK market as you do now, until your new packaging implementation date.

If you do not want a national MA please contact s.response@vmd.gov.uk with product details, however, your Centralised MA will only be valid in NI.

Existing Generic products authorised with a European reference product (updated 23/10/20)

Generic products authorised prior to 31 December 2020 which cite a European reference product may remain on the market. However, 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.

Ongoing applications

An ongoing application is one that is still under assessment on 1 January 2021. This applies to all national and European applications for new national, MRP, DCP and Centralised MAs, variations and renewals

National Applications

National applications will continue on a national basis. For a new MA application, if the outcome is favourable you will be issued with an MA valid UK wide, subject to the UK and EU operating an equivalent regulatory framework.

From 1 January 2021 you must use the Veterinary Medicines Digital Service (VMDS) to manage your applications and securely communicate with us.

MRP and DCP applications

MRP and DCP applications will continue in accordance with the EU timetable. For a new MA application, if the outcome is favourable and UK and EU opinions are aligned, you will be issued with an MA valid UK wide, subject to the UK and EU operating an equivalent regulatory framework and opinions align.

If UK and EU opinions are not aligned, where possible, you may be issued separately 1 GB MA in accordance with UK Regulations and 1 NI MA in accordance with the EU Regulations. If differences seem likely we will discuss this with you.

We will update this section with more information as it becomes available.

Centralised Applications (updated 09/11/20)

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. If differences in EU and UK opinion seem likely we will discuss this with you.

We will update this section with more information as it becomes available.

New MA options available in the UK from 1 January 2021

New national MAs

New national MAs that you can apply for in the UK from the 1 January 2021 are:

  • GB MA valid in Great Britain only and subject to UK regulations. These cannot be marketed in NI.

  • NI MA valid in Northern Ireland only and subject to EU regulations

Where possible, you can use the same packaging for the same product with MAs in both territories.

New MRP/DCP MA

MRP or DCP procedures are issued with national authorisations by each member state - this will not change. NI can act as CMS and therefore these products will receive a national NI MA issued by the VMD, which will be subject to EU Regulations and valid in NI

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