Application and authorisation information hub explainer
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Centrally authorised products conversion
From 1 January 2021, Northern Ireland continue to be included within the scope of the Centralised procedure. Your existing Centrally Authorised Product (CAP) Marketing Authorisation (MA) issued by the European Medicines Agency (EMA) will continue in place in Northern Ireland and remains subject to EU Regulations.
We have issued a GB MA certificate for those CAPs you requested be converted to a GB MA and you will need to take further actions within set timeframes, as set out below, to retain continued authorisation of your GB MA.
These products will be subject to national post-authorisation procedures, for example renewals, variations and reporting product defects and adverse events. The validity date will continue to be the date the original authorisation was granted. Where a renewal has already taken place, the MA will remain valid indefinitely.
Your new GB national MA SPC/QRD will likely be formally issued as part of the next variation that affects these documents.
Information you must provide to support your conversion
By 30 June 2021 - Minimal information for each product, via VMDS Secure Messaging. This requirement has now been fulfilled by industry, thank you for your cooperation.
By 1 January 2024 (there will be no further extensions beyond this date), via VMDS Secure Messaging - You must provide a copy of the full data baseline dossier for each product which is current at the time you send it. The dossier should reflect the product as it currently exists and should also include a list of all variation history. There is no need to remove any EU references.
As part of this data capture exercise, it may be necessary for the VMD to request the Active Substance Master File (ASMF) for some of the converted products. In these cases, we will contact the MA Holder directly, and request that they liaise with the ASMF holder to arrange timely submission.
If the ASMF Holder is not registered to use VMDS Secure Messaging, they will need to request access as an ‘ASMF Manufacturer’ through the Veterinary Medicines Digital Service.
To provide you with more time to complete these activities, the submission deadlines were extended by 6 months. However, we may ask you to provide these documents earlier should it be necessary because of life cycle management or post authorisation activity.
Failure to provide any of the information listed above will be in contravention of the MA and the VMR. If any details are later found to be incorrect, we may suspend or revoke your MA.
Updates to packaging to support your conversion
Converted Centrally authorised products were given a GB Vm number, which was included on your new MA documentation. The GB Vm number can be added as part of the ‘blue-box’ for nationally required information to maintain packaging alignment with the EU, subject to the acceptance of other EU Member States.
Variation applications to include your new Vm number and any other related changes affecting packaging must be submitted by 1 January 2024.
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.
You can choose to introduce these mock-ups as part of another application that affects them (not VNRA), or you can submit mock-ups for assessment under cover of a separate variation (VRA G.I.15.z).
Summary of Product Characteristics and Joint labelling
It will be possible to maintain harmonised Summary of Product Characteristics (SPC) and labelling text with products authorised in the EU or Northern Ireland and GB. It will be up to you to submit future applications that affect the SPC and labelling text to both the VMD and the EU in parallel and to keep us updated on the progress of the EU procedure. Where necessary, we may reach different conclusions and propose different SPC or QRD wording if it is more appropriate based on conclusions from the assessment of the data provided in support of the application.
Third country information is not permitted on an EU CAP label; however, it will be possible for GB information to appear in the ‘Blue Box’ whilst the SPCs and labelling text remain harmonised.
Product defects
Product defects concerning products authorised in the UK must be reported directly to the VMD. This includes those products originally authorised via European procedures.
Summary of actions for Marketing Authorisation Holders
- By 1 January 2024 – submit full baseline dossier
- By 1 January 2024 – submit variations to update packaging
- By 1 July 2023 – open and closed parts of any missing ASMFs may be requested and should be submitted by the ASMF holder
Marketing Authorisation Holder Location
Centrally authorised Marketing Authorisations
For Centrally authorised MAs the MA Holder (MAH) must be located in the EU for these products to be on the Northern Ireland market.
National, decentralised and mutually recognised Marketing Authorisations
For national, decentralised and mutually recognised MAs, the UK’s legal interpretation of the MAH location requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of Northern Ireland, the MAH can be located in GB or Northern Ireland for the product to be on the GB and/or Northern Ireland markets.
Therefore, for GB MAs, NI MAs (national, decentralised or mutually recognised) and UK MAs, as applicable:
- To market in Northern Ireland: MAH location can be in GB, Northern Ireland or the EU
- To market in GB: MAH location can be in GB or Northern Ireland and we will also continue with the current arrangement for products placed on to the GB market. Any changes to the Regulations will be subject to formal, public consultation when you will have an opportunity to comment on proposals. We recommend waiting for these additional details before making MAH location changes.
Named Distributor
We will continue to recognise EU locations for named distributors for batches of products placed on the GB market. The proposed changes to the Regulations will be subject to formal, public consultation when you will have an opportunity to comment on proposals. We recommend waiting for these additional details before making changes.
Marketing Authorisations granted prior to 31 December 2020
National, decentralised and mutually recognised Marketing Authorisations
National, decentralised and mutually recognised MAs granted prior to 31 December 2020 are valid in the UK, 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. There are likely to be actions you must take to ensure your packaging includes information relevant to UK Regulations. Any changes to the Regulation will be subject to formal, public consultation when you will have the opportunity to comment on proposals. We recommend waiting for these additional details before making changes.
To continue to market these products in Northern Ireland, your MA must meet EU Regulations. 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 Northern Ireland.
Centrally authorised products
Northern Ireland will be included within the scope of the Centralised procedure. Marketing Authorisations issued by the European Medicines Agency, including those granted prior to 31 December 2021, will continue in place in Northern Ireland and remain subject to EU Regulations. These will no longer be valid for the GB market.
Centrally Authorised Products converted to GB MAs
Centrally authorised products which were converted to a GB MA from 1 January 2021 may remain on the 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.
To support this conversion, variation applications to assess your GB mock-ups, including your new Vm number and any other related changes affecting packaging, must be submitted by 1 January 2024.
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.
Generic products authorised by 31 December 2020 with a European reference product
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 no longer exists, you must provide us with any data needed to develop your MA for future variations.
Parallel submission of generic applications
The VMR and the Northern Ireland Protocol make it clear that the reference product cited in an application for a generic product;
- submitted to GB - must have a reference product that is authorised in the UK
- submitted to NI, either nationally or via the Decentralised Procedure with NI as a Concerned Member State - must have a reference product authorised within the EU.
To submit parallel submissions in GB and NI, the respective reference products in the UK and the EU must be qualitatively and quantitatively identical in terms of composition with identical SPCs. If not, then a parallel submission is not possible as the products are not considered to be the same. In such cases separate GB and NI submissions must be made.
Qualitative and quantitative identicality
It cannot be assumed that products authorised on a national only basis in the EU and the UK are the same from a qualitative and quantitative perspective, even if they have the same MAH. You must confirm in a covering letter, or include an application note in VMDS, that a parallel application is justified.
If during our assessment it transpires that the respective reference products are not qualitatively or quantitatively identical or where the SPCs are not identical, depending on the data provided it may not be possible to conclude the application positively. For example if the EU reference product was used as the comparator product in bioequivalence studies or comparative/deconvolution studies were conducted on the EU reference product to support a bioequivalence waiver, this would not be appropriate for GB even though a similar product is marketed by the same MAH in GB.
Where it cannot be assured that the respective reference products are qualitatively and quantitatively the same we would expect to see that the data packages provided in support of the GB and NI submissions reflect the use and comparison to the appropriate reference product.
Examples of scenarios which might be suitable for parallel submission
Although not an exhaustive list, possible scenarios where the respective EU and UK reference products might be qualitatively and quantitatively identical and therefore suitable for parallel submission (subject to the SPCs also being identical) are those:
- with an authorisation history where the UK and EU reference products were authorised via a European procedure and the post authorisation activities have been mirrored
- where an auto-generic is being applied for and the applicant can demonstrate that the respective reference products are qualitatively and quantitatively identical
- where the products have simple identical formulations, such as 100% active ingredient or a simple 2 component solution
Further guidance is given in the application form.
Labelling and packaging
Variations for all Marketing Authorisations
We are considering the arrangements for post 2022, which will depend on the new Veterinary Medicines Regulations and we will consult with you on this in due course.
As a result of the new Regulations, there are likely to be actions you must take to ensure your packaging meets the requirements. We recommend waiting for these additional details before making changes.
Product Literature Standard
The principles of the Product Literature Standard remain unchanged however this has been updated to reflect the requirements for UK wide, GB and NI MAs.
Deviation of labelling requirements for certain GB Marketing Authorisations to facilitate multi-country labelling
Multi-country packs are permitted for veterinary medicines that share a common label to allow their placing on the market in several countries. To enable this, the Summary of Product Characteristics (SPC) and approved labelling text (QRD) must be the same in all countries concerned.
Multi-country packs within the EU (including Northern Ireland) are subject to labelling requirements set out in Title V of Directive 2001/82/EC, which allows for individual member States to require the inclusion of additional country specific labelling information in a restricted ‘Blue-Box’ area on the outer packaging.
For products granted a marketing authorisation under the Centralised Procedure in the EU, and which have a package leaflet, the GB requirement to include GB marketing authorisation holder/distributor details (if different to the EU marketing authorisation holder information) and the GB Vm number on the package leaflet is not conducive to multi-country packs.
Therefore, for veterinary medicines authorised under the Centralised Procedure in the EU and where a parallel, identical GB marketing authorisation/application has been issued or received, the VMD will not enforce Veterinary Medicines Regulations 2013 (VMR) Schedule 1 Part 7, paragraph 50 (1) as it has affect in GB in regards to inclusion of all product information on the package leaflet when this cannot be presented on the immediate or outer packaging. Specifically, the VMD will not enforce a requirement for inclusion of the name and address of the GB marketing authorisation holder/distributor (if different to the EU marketing authorisation holder information), and the GB Vm number on the accompanying package leaflet.
Instead, if the name and address of the GB marketing authorisation holder/distributor (if different to the EU marketing authorisation holder information), and the GB Vm number are not included on the package leaflet, information specific to GB are to appear in the ‘Blue Box’ on the outer packaging (or immediate packaging if no outer packaging). The country abbreviations GB or UK(GB) and UK(NI) are acceptable for use on all packaging and leaflets. The abbreviation ‘XI’ for Northern Ireland should not be used.
For example:
UK(NI) and UK(GB) or GB: legal category
[Paragraph break]
UK(GB) or GB: Vm XXXXX/XXXX
MAH/distributor name and address [if different to EU information] [Any further national specific information, such as indication if the product is an anthelmintic or controlled drug]
This exceptional VMD enforcement policy only applies in instances where the GB and EU SPC and QRD, as agreed under the respective procedures, are the same. Where divergence occurs, a single multi-country label will not be achievable and national labelling requirements as described in Schedule 1 Part 7 of the VMR apply in respect of the GB product.
Maximum Residue Limits
Maximum Residue Limits in Northern Ireland
Under the Northern Ireland Protocol, Northern Ireland will operate under EU rules. This means that Maximum Residue Limits (MRLs) set by the European Commission must be used for products authorised in Northern Ireland.
You must submit the same application and all procedurally related communications that you provide to the EU to us via VMDS Secure Messaging or Eudralink within 2 working days.
Maximum Residue Limits in Great Britain
MRLs listed in Commission Regulation (EC) 37/2010 or published in the Official Journal prior to 31 December 2020 will continue to have effect in GB and will be included on the list of from 1 January 2021.
For MRLs in GB, you will need to apply to the VMD, via VMDS Secure Messaging or Eudralink, to:
- establish new MRLs for pharmacologically active substances
- extend an existing MRL, for example same substance but different species and/or food commodity
- change an existing MRL
See Maximum Residue Limits for more information
Guidance links
Below are quick links to some key VMD guidance documents you might find useful:
- Marketing authorisations for veterinary medicines
- Apply for a Marketing Authorisation in the UK for a veterinary medicine or expire one
- Submission of an application for an animal medicine authorisation
- Variations to a veterinary Marketing Authorisation or Homeopathic Remedy
- Fees applied to animal medicine authorisation applications
- Maximum Residue Limits
Updates to this page
Last updated 18 May 2023 + show all updates
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Centrally authorised product conversion: Deadline (final) amended to 1 January 2024 for receipt of full data baseline dossier for each product which is current at the time you send it.
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Further five month extension to the deadline for submission of mock-ups to support CAP conversion to GB marketing authorisation.
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Six month extension to the deadline for submission of baseline dossiers, ASMFs and mock-ups to support CAP conversion to GB marketing authorisation.
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Added section 'Deviation of labelling requirements for certain GB Marketing Authorisations to facilitate multi-country labelling.'
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Added section for Parallel submission of generic applications
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Centrally authorised products conversion – added submission via VMDS Secure Messaging
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Update to the product literature paragraph.
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First published.