# Marketing authorisation applications referred under Article 29

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/f75ef729-5434-4208-8466-520a967cd16d
Type: Detailed Guide
Published: December 31, 2020
Updated: March 11, 2025

> This regulatory guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) details the procedures for Marketing Authorisation Applications (MAAs) involved in Article 29 referrals under Directive 2001/83/EC. Such referrals are triggered when EU member states fail to reach a consensus on an application due to potential serious risks to public health. Although the document does not target a specific company, inspection date, or violation, it clarifies the MHRA's role as the competent authority for Northern Ireland within the EU's mutual-recognition and decentralised procedures. The regulatory framework dictates that decisions reached by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) or the Committee for Medicinal Products for Human Use (CHMP) are binding for Northern Ireland. This mandate continues through and beyond January 2025. For UK-wide authorisations, the MHRA intends to apply these referral outcomes across the entire UK to ensure regulatory alignment, unless specific domestic changes necessitate withdrawing Northern Ireland from the procedure. Applicants are required to wait for the conclusion of the Article 29 referral process before the MHRA proceeds with final determination of the application. This protocol ensures that any serious public health concerns identified during the evaluation process are fully addressed before a product is permitted on the market in Northern Ireland and, by extension, the broader United Kingdom.

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## Content

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 2025, 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. 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 the Article 29 outcome. 3. Contact For further information, email our Customer Services Centre at RIS.NA@mhra.gov.uk .