Veterinary Medicines Directorate
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 July 2023 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 UKs 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.