GovWire

1. Overview

Article 29 of Directive 2001/83/EC provides for referrals that are triggered when a consensus cannot be reached between EU Member States on the outcome for a Marketing Authorisation Application (MAA) which has been evaluated in a mutual-recognition procedure (MRP) or decentralised procedure (DCP), on the grounds of a potential serious risk(s) to public health (PSRPH).

2. How the MHRA will manage MAAs in these referrals

Until 31 December 2024, where Northern Ireland (NI) is a Concerned Member State (CMS)?for MAAs that have been referred under Article 29, where either a positive or negative opinion has been taken at the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh) or the Committee for Medicinal Products for Human Use (CHMP), the Medicines and Healthcare products Regulatory Agency (MHRA) will complete the assessment of the application as follows:

2.1 Application for an NI MA only

The outcome of the Article 29 referral will be binding on the MHRA as the competent authority for NI. No actions will be taken until the application is determined in line with the Article 29 outcome.

2.2 Existing authorisations for a UK marketing authorisation (MA)

Since 1 January 2021, it has not been possible for a UK-wide MA to be applied for through the EU MR or DC procedures. It has been possible for NI to remain as a CMS within a UK-wide MA managed in line with the EU procedure. Therefore the application may become the subject of an Article 29 referral as part of a repeat use procedure. The outcome of the Article 29 referral will be binding on the MHRA with respect to NI. No actions will be taken until the Article 29 outcome has been decided.

Unless there is a requirement for UK-specific changes, the MHRA will adopt the Article 29 outcome and apply it to the UK-wide MA.

If UK specific changes are needed NI will then have to be withdrawn from the procedure.

2.3 From 1 January 2025

From 1 January 2025¹, NI will continue to participate in referrals under Article 29 where it is a CMS and will be bound by the outcome of the CMDh or CHMP decision.

^{1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14}

2.4 Existing authorisations for a UK MA (gained through MRP/DCP)

For historical UK licences, where NI remains as a CMS within a UK-wide MA managed in line with the EU procedure where an application may become the subject of an Article 29 referral as part of a repeat use procedure, the outcome of the Article 29 referral will be binding on the MHRA with respect to NI. No actions will be taken until the Article 29 outcome has been decided.

Unless there is a requirement for UK-specific changes, the MHRA will adopt the Article 29 outcome and apply it to the UK-wide MA.

If UK specific changes are needed NI will then have to be withdrawn from the procedure.

2.5 Application for an NI MA only

The outcome of the Article 29 referral will be binding on the MHRA as the competent authority for NI. No actions will be taken until the application is determined in line with theArticle 29 outcome.

3. Contact

For further information, please email our Customer Services Centre at RIS.NA@mhra.gov.uk.