Centrally authorised products and the Northern Ireland Protocol

A centrally authorised product (CAP) is one that has been assessed on a Community level involving all EU Member States (MSs). A pan-European authorisation is issued by the European Medicines Agency (EMA) permitting the marketing, sale and supply of the product in all EU MSs.

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

Automatic conversion to a GB Marketing Authorisation (updated 09/11/20)

All CAPs granted prior to 31 December 2020 can automatically become valid in GB on 1 January 2021. We will email you soon asking you to confirm that you would like a GB MA for each of your current CAPs.

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 by the EMA; the conversion to national status does not change this. Where a renewal has already taken place, the MA will remain valid indefinitely. Those yet to be renewed will be subject to a national renewal.

Products which have been Qualified Person (QP) released and on the market before the new packaging implementation date may remain for sale and supply in their existing packaging.

MA Certification and Vm number

From 1 January, your GB MA will be in effect, and we will send you your GB MA certificate after 1 January 2021 which will include the new Vm number.

Until 1 January 2023, we will continue to accept a Marketing Authorisation Holder (MAH) location in the EU for existing and new GB MAs. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making MAH location changes to meet GB requirements.

We can issue your new GB MA certificate with details of your UK MAH location if you have one, free of charge, if you provide the information when you confirm you would like the GB MA. Once the certificate is issued, you will need to submit a variation to change these details in future.

GB MAs will be issued per pharmaceutical form / strength with pack sizes consolidated.

Information you must provide to support your conversion

Minimal information – submitted by 30 June 2021

By 30 June 2021, you must provide the following for each product:

• a completed memorandum document using the templates provided below
  • pharmaceuticals products
  • biological products
• for pharmaceutical products only, the finished product specification and active substance specification
• flowchart of the final manufacturing process

We won’t assess these documents until they are submitted as part of an application that affects them, but you must confirm in your covering email that the documents are the latest versions approved by the EMA. Failure to provide this information will be in contravention of the MA and the Veterinary Medicine Regulations (VMR). If any details are later found to be incorrect, we may suspend or revoke your MA.

We may ask you to provide these documents earlier than 6 months should it be necessary due to adverse event reports.

Full baseline dossier – submitted by 1 January 2023 (updated 09/11/20)

By 31 December 2022, you must provide a copy of the full data dossier for each product which is current at the time you send it. There is no need to remove any EU references.

Failure to provide this information 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.

We may ask you to provide these documents earlier should it be necessary because of life cycle management or post authorisation activity.

Updates to packaging to support your conversion (updated 09/11/20)

Variation applications to include your new Vm number and any other related changes affecting packaging 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.

You can choose to include these changes to mock-ups that will be assessed as part of another application that affects them (not Type IA variation), or you can submit mock-ups for assessment under cover of a separate variation (category C.II.6(b)).

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/NI and GB. It will be up to you to submit future applications that affect the SPC and labelling text to both the VMD and 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 and/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 Information Database, Public Assessment Reports and Post-Authorisation Assessment documents

We will continue to publish details of products authorised in the UK on the Product Information Database (PID).

For products originally authorised Centrally we will signpost to the Public Assessment Reports (PuAR) available on the European Medicines Agency website. We will not create PuARs retrospectively but will publish on the PID details of any significant changes made to the product since 1 January 2021.

We will create a Post-Authorisation Assessment (PAA) document upon issue of the first application completed after the 1 January 2021. Information about post-authorisation activities completed prior to 31 December 2020 will remain available on the EMA website.

Actions for Marketing Authorisation Holders (updated 09/11/20)

• Respond to our email with confirmation that you would like a GB MA, including any information you want included on your MA, by the deadline given in the email
• By 30 June 2021 – submit minimal information
• By 1 January 2023 – submit full baseline dossier
• By 1 January 2023 – submit a variation to update packaging to include your new Vm number and MAH location/named distributor details, as necessary.