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

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.

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.

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 only.

To access the GB market, it will be possible to run the MRP/DCP and national procedures on parallel timetables.

Where possible, you can use the same packaging for the same product for MRP/DCP MAs and GB MAs.

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.

To access the GB market, it will be possible to run the Centralised and national procedures on parallel timetables. Where possible, you can use the same packaging for the same product for Centralised MAs and GB MAs.

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

Parallel submissions (updated 23/10/20)

New GB and national only NI MA applications

You can submit applications for a new GB MA and a new NI MA in parallel to facilitate UK wide coverage and to allow for efficient application management, such as a single application supported by a single data set.

National only parallel submissions must be made in one application, by selecting both GB and NI, and must be for the same product, meaning they:

• are the same pharmaceutical form
• have the same qualitative and quantitative composition
• are intended for the same target species with the same or similar indications
• have a shared dossier. Except for certain differences that make no impact on the scientific requirements or regulatory framework such as sites of batch release and product name

To benefit from parallel submissions, you must only submit applications that meet the regulatory requirements of both territories. For example, a generic GB MA application can’t cite an EU reference product which would rule out the submission of such an application in GB.

New GB and EU MA applications (updated 23/11/20)

You can submit in parallel applications for a new GB MA and a new DCP MA where NI is CMS or for a Centrally authorised product to facilitate UK wide coverage and to allow for efficient application management, providing the opportunity for both applications to be managed within similar timeframes across regulatory jurisdictions.

You must submit your EU application through CESP (DCP) or via the Common Repository (CAP) and then, within 2 working days at the latest, submit the GB MA application to the VMD via the Veterinary Medicines Digital Service (VMDS). As confirmation, you must include the date you submitted your EU application and the DCP EU reference number in the comments box in the GB MA online form. If you have your CAP reference number in time, please include this. Applications must also be for the same product, meaning they:

• are the same pharmaceutical form
• have the same qualitative and quantitative composition
• are intended for the same target species with the same or similar indications
• have the same dossier. Except for certain differences that make no impact on the scientific requirements or regulatory framework such as sites of batch release and product name. Both variants must be included in the dossier submitted in support of the GB MA application

As the procedure progresses it is your responsibility to ensure we are aware of information and timetables (including timetable amendments) that you wish to be considered during our assessment. You may also need to provide us with EU Lists of Questions (LOQs) and your responses in order to maximise the potential for harmonised labelling.

To benefit from parallel submissions, you must only submit applications that meet the regulatory requirements of both territories. For example, a generic GB MA application can’t cite an EU reference product which would rule out the submission of such an application in GB.

Variation applications (updated 23/11/20)

You can submit applications in parallel for variations to coordinate identical proposed changes to GB MAs, NI MAs (national, MRP and DCP) and UK wide MAs to allow for efficient application management, providing the opportunity for multiple applications to be managed within similar timeframes across regulatory jurisdictions.

If applicable, 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. As confirmation, you must include the date you submitted your application and any EU reference numbers, if you have them, in the comments box in the VMDS online form.

Applications must also be for the same product, meaning they:

• are the same pharmaceutical form
• have the same qualitative and quantitative composition
• are intended for the same target species with the same or similar indications
• have the same dossier. Except for certain differences that make no impact on the scientific requirements or regulatory framework such as sites of batch release and product name

Where a parallel submission involves an EU procedure, as the procedure progresses, it is your responsibility to ensure we are aware of information and timetables (including timetable amendments) that you wish to be considered during our assessment. You may also need to provide us with EU Lists of Questions (LOQs) and your responses in order to maximise the potential for harmonised labelling.

Marketing Authorisation numbers (updated 23/10/20)

Marketing Authorisation numbers will continue to be prefixed with the letters ‘Vm’ and configured using the company number followed by the product number.

To be able to identify where the MA is valid for sale and supply, using the Vm number, the first number of the product number element will be used as a territory identification number. These are:

• 4 – UK wide – For existing MRP/DCP and national MAs maintaining a UK wide authorisation. This will mean no change as all product numbers currently start with the number 4
• 3 – NI MA – For MAs authorised in NI only via MRP/DCP or national NI procedures
• 5 – GB MA – For MAs valid in GB only

If you chose to separate your existing UK wide MAs, or MA divergence is introduced, your Vm number will change from (example) 01234/4321 to 01234/3000 for your first NI MA and to 01234/5000 for your first GB MA.

Centrally authorised products will only be valid in NI and will continue to display the EU MA number. You will be offered a GB MA for existing centrally authorised products which will be issued with an MA number in this new format, for example: 01234/5000 (for your first GB MA).

Joint labelling with Ireland will continue to be possible by displaying both the EU MA number and the GB Vm number on your packaging using the ‘Blue box’ concept for national specific information.

UK and EU operating an equivalent regulatory framework and opinions align (updated 23/10/20)

Whilst the UK and EU operate an equivalent regulatory framework and opinions align, and you do not introduce divergence to the MA, you will be able to maintain your existing MAs which are valid UK wide. This also includes continued alignment of the data package, Summary or Product Characteristics and labelling.

Regulatory alignment

If the Regulations diverge, it may be necessary to separate these MAs to allow for regulatory differences. This would mean you would have 1 MA valid in GB, subject to UK Regulations and 1 MA valid in NI, subject to EU Regulations.

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

Opinion alignment

If the UK and EU opinions are not aligned it may not be possible to maintain an MA valid UK wide. Depending on the reason for difference in opinion, you may be able to separate the MA to 1 MA valid in GB, subject to UK Regulations and opinion, and 1 MA valid in NI, subject to EU Regulations and opinion.

This means that 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.

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

Introducing divergence to an MA

To maintain alignment of your UK wide MAs authorised via, MRP or DCP procedures, you must submit post authorisation applications to both the EU and the VMD for assessment at the same time. By not submitting applications to either authority will introduce divergence and your MA may be separated into 1 MA valid in GB, subject to UK Regulations and 1 MA valid in NI, subject to EU Regulations.

Maintaining and separating existing UK Wide MAs (updated 23/10/20)

The onus is on you to maintain your existing UK wide MA, if you so wish, by not introducing divergence. Equally, you can choose to separate your UK wide MA to 1 GB MA (subject to UK Regulations) and 1 NI MA (subject to EU Regulations).

National only UK wide MA

As described under UK and EU operating an equivalent regulatory framework and opinions align you will be able to maintain your existing MAs which are valid UK wide.

Unless it is your intention to do so, you must ensure that variations do not introduce changes that contravene either UK or EU regulations, as this may result in MA separation.

Upon separation, your new GB and NI MAs will be issued with a new Vm number for each, which will mean necessary changes to product literature and packaging.

Originally authorised via MRP and DCP (updated 23/11/20)

As described under UK and EU operating an equivalent regulatory framework and opinions align you will be able to maintain your existing MAs which are valid UK wide.

To maintain a UK wide MA, you must ensure that variations are submitted under both GB and EU routes at the same time in order to retain alignment. However, changes which may occur during the respective assessment by the GB and EU authorities could introduce changes that either contravene UK or EU regulations or change the terms of authorisation valid in GB and NI, which may result in MA separation.

Additionally, you must submit variation or renewal applications to the EU through CESP and then, within 2 working days at the latest, submit the applications to the VMD. As confirmation, you must include the date you submitted your EU application in the comments box in the online form.

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, which will mean necessary changes to product literature and packaging.

New applications from 1 January 2021

The data and documents required in support of an application remain unchanged and are set out in:

• Volumes 6a and 6b of the Notice to Applicants
• Annex I to Directive 2001/82/EC, as amended
• Commission Regulation (EC) 1234/2008, as amended (so-called ‘Variation Regulations’); and supporting Classification Guideline which details the various categories of variations

The current EU and CVMP guidelines will continue to be used until we establish our own guidance. We will keep you updated on this.

National Marketing Authorisations

National applications and related correspondence must be submitted through the VMDS

Generics

For GB MAs, the reference product cited in an application for a generic product must be authorised in the UK and in accordance with any of the following articles in Directive 2001/82/EC, as amended: 12(3), 13(a), 13(b) or 13(c).

For national NI MAs, the reference product cited must be authorised in the EU or the UK.

Bibliographics

If the active substance has well established use in that target species, for the required indication, in any other country for at least 10 years, and you can provide the scientific literature to demonstrate this, then you don’t need to provide the results of safety tests, residue tests, pre-clinical or clinical trials.

Renewals

For national NI, GB and existing UK wide MA renewals, the UK procedure has not changed. For MAs authorised Centrally or through MRP/DCP the EU procedure will apply for NI.

Variations

For national NI, GB and existing UK wide MA variations, the UK procedure has not changed. For MAs authorised Centrally or through MRP/DCP the EU procedure will apply for NI.

To maintain alignment between NI and GB MAs you must submit your applications to the EU authority and VMD in parallel.

MAs for Parallel Imports (MAPIs)

The UK MAPI scheme will continue post transition period.

For GB MAs you must prove that the product to be imported is identical and/or therapeutically equivalent to the UK authorised product. Failure to do so will result in the application being refused.

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.

MAPI holders must be established in the UK.

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

Timetable options

In addition to normal timetables, we will be introducing an option for you to submit GB national procedures in parallel with European procedures.

You will need to inform us upfront of your intentions and tell us the EU validation and timetable dates (including any subsequent timetable changes) so that we can run the GB procedures to the same key milestones. This means that you should receive the GB and EU list of questions at a similar time. You must also keep us informed of EU developments as best you can during the procedure.

Running a procedure in parallel could:

• enable you to have a single project team working on both applications, although GB, NI and the EU will remain separate regulatory jurisdictions
• help to facilitate joint labelling with GB, NI and Ireland. Although we cannot guarantee reaching the same outcomes as the EU, running submissions in parallel does provide the opportunity to take into consideration the EU position

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

UK Public Assessment Reports

A UK Public Assessment Report (UKPAR) will be available on the Product Information Database (PID) for products nationally authorised since 31 October 2005 and those originally authorised under MRP. If an UKPAR is not immediately available, we will endeavour to populate the PID overtime so that all entries for UK authorised veterinary medicinal products have a published UKPAR.

For products originally authorised via centralised procedure we will signpost to the European Public Assessment Report (EPAR) available on the European Medicines Agency website. We will not create UKPARs retrospectively but will publish on the PID details of any significant changes made to the product since 1 January 2021.

Product defects

From 1 January 2021, product defects concerning products authorised in the UK must be reported directly to the VMD. This includes those products originally authorised via European procedures.

Referrals

We have the authority and procedures in the UK for reviewing products and requesting changes (as per Article 35) and for taking action as a result of Pharmacovigilance data (as per Article 78), should new data/evidence come to light.

NI MAs and existing MAs valid UK wide authorised through EU procedures remain subject to EU Referral procedures.

Marketing products in the EU

The European Medicines Agency (EMA) and CMDv have published guidance to companies on the preparations needed to market products in the EU, which will apply to Marketing Authorisations valid in NI.

Contact

If you have any questions please email: vetmedtrade@vmd.gov.uk