Guidance

Centrally Authorised Products (CAPs) Bridging Mechanism

Published 9 June 2023

Overview

This guidance applies until such time as the Windsor Framework takes effect on 1 January 2025. Under the Windsor Framework, rather than novel medicines for use in Northern Ireland requiring an application to the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) will assess applications and license all products in the scope of the EU’s Centralised Procedure on a UK-wide basis.

In the interim, until the Windsor Framework is implemented, decisions taken by the European Commission (EC) on the approval of new Marketing Authorisations (MA) in the centralised procedure will continue to be applicable to Northern Ireland, in accordance with EU law.

MAs issued by the EC in relation to Centrally Authorised Products (CAPs) are not valid in Great Britain (GB) and a separate national application is needed for GB. There is therefore a possibility that in the case of parallel applications to the EMA and the MHRA, the MHRA will issue an MA for a medicinal product before an MA has been granted for the same medicinal product in the EU. Where this is the case, under a CAP bridging mechanism, companies will be able to supply a GB licenced product (PLGB) to Northern Ireland for a period of 6 months, or until the EC authorises a CAP in Northern Ireland, or the EC refuses an application for the product, whichever is sooner. This will help to ensure that patients in Northern Ireland have access to those medicinal products at the same time as patients in other parts of the UK. The CAP bridging mechanism is part of an EU legislative package for medicines passed in April 2022.

Application process

See General guidance on submitting a licencing application to the MHRA. The MHRA will review the application and, if appropriate, issue a marketing authorisation.

If the medicinal product is likely to be authorised by the MHRA before authorisation for the EU CAP is granted or refused, the applicant must notify the MHRA via RIS.NA@mhra.gov.uk. At the time of PLGB authorisation, the MHRA will place the product on the CAP bridging list and the MHRA will issue a PLGB that is also valid in Northern Ireland.

The PLGB product can be supplied across the UK, including to patients in Northern Ireland where a CAP has not been approved by the EU for up to 6 months. The MHRA will publish a list of PLGB products that are licensed under the bridging mechanism and are therefore also licensed for Northern Ireland.

For those products where a Pharmaceutical Interface Product (PIP) code is applicable, where the bridging mechanism is applied to the licence, the MAH should obtain a PIP code from Chemist & Druggist (C&D) Data by supplying:

• the product description;
• PLGB number;
• marketing region information (UK); and
• Global Trade Identification Number (GTIN).

Once in receipt of the PIP code, the MAH should supply those details to manufacturers and wholesalers, as required. MAHs and wholesalers should then manage the manufacture and supply of the PLGB product to GB and Northern Ireland, using the UK marketing region data associated with the PIP code. For further information on PIP codes, please email Informa/Pharma Intelligence UK at info@cddata.co.uk.

Once the EU has made a decision on an application for a CAP or 6 months has passed, the PLGB product will only be authorised in GB. If approved by the EU, the CAP will only be authorised for Northern Ireland. MAHs will therefore need to take the following actions to ensure that wholesalers and distributors are aware of which packs can be distributed to Northern Ireland and GB:

• notify the MHRA via RIS.NA@mhra.gov.uk that a CAP has been approved by the EU;
• obtain a new Northern Ireland PIP code for the CAP; and
• amend the marketing region data associated with the PLGB PIP code to GB.

Wholesalers will be informed of the changes in the electronic files they receive from C&D. The MHRA will also update the published list of PLGB products that have been approved under the bridging mechanism and remove the PLGB products where 6 months has passed or the EC grants or refuses an application to market the CAP in Northern Ireland.

Advertising and promotion

PLGB products that have been approved and are supplied under the CAP bridging mechanism can be advertised and promoted in Northern Ireland for the period that they are authorised in this way. MAHs will need to continue to ensure that all relevant statutory requirements for the promotion of medicines are met (as outlined in the Blue Guide, which provides detailed guidance on advertising and promotion of medicines in the UK).

After the end of the bridging period

MAHs are reminded of their responsibilities to report shortages and discontinuations of supply to the Department of Health and Social Care (DHSC). In the event that an EU application is not completed within the period of 6 months after the CAP bridging authorisation, MAHs should consider the impact on supply to UK patients resident in Northern Ireland and give notice to DHSC, as appropriate.

The MAH should also amend the PIP code to remove Northern Ireland from the marketing region and the product will revert to being supplied to GB only. Where it appears to the MAH that they are unlikely to get the EC’s decision on CAP authorisation within the 6-month bridging period, the MAH should inform the DHSC Medicine Supply Team at DASH@dhsc.gov.uk. At the point of MHRA approval, the MHRA will remind MAHs of these obligations in the grant letter.

The MHRA will remove the affected product from the published bridging mechanism list and an alternative mechanism such as the Northern Ireland MHRA Authorised Route (NIMAR) will be considered for the supply of the affected product into Northern Ireland if required, ensuring the clinical needs of patients are met. This will be determined on a case-by-case basis.

Any PLGB stock already placed on the market (i.e. released by a Qualified Person (QP)) in Northern Ireland under the bridging mechanism (held either at wholesale or pharmacy level or pending orders) can continue to be supplied to patients until the date of their expiry. It is the QP’s responsibility to check the published CAP bridging list and ensure that only products on the list are released in Northern Ireland.

Guidance on further transitional arrangements to the Windsor Framework for medicines, including any making use of the bridging mechanism, will be published in due course, as part of the implementation process.

For more information on the process see the Centrally Authorised Product (CAP) Bridging Mechanism flowchart

Contact

For further information on the CAP bridging mechanism, please email our Customer Services Centre at RIS.NA@mhra.gov.uk

For further information on PIP codes, please email Informa/Pharma Intelligence UK at info@cddata.co.uk