UK MHRA Guidance: International Recognition Procedure – Streamlining Access to Medicines in Great Britain

In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and effective medicines. Recognizing this need, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the International Recognition Procedure (IRP) — a forward-thinking approach that builds on international trust and harmonization.

As of 13 May 2025, the MHRA updated its guidance on this innovative regulatory route. The IRP enables faster market access in Great Britain by relying on assessments already completed by trusted global regulatory partners.

International Recognition Procedure (IRP): A regulatory pathway introduced by MHRA that allows certain medicinal products to be authorized in Great Britain by recognizing decisions made by specific Reference Regulators.

The IRP enables the MHRA to rely on prior assessments conducted by one of seven Reference Regulators (RRs), thereby reducing duplication and accelerating market access for patients in Great Britain. It applies to:

• New MAA submissions

• Post-authorisation applications (such as variations and renewals)

Reference Regulators (RRs) authorities that MHRA deems scientifically robust. These include:

• The European Medicines Agency (EMA)

• Health Canada

• Swissmedic

• The US Food and Drug Administration (FDA)

• Australia’s Therapeutic Goods Administration (TGA)

• Singapore’s Health Sciences Authority (HSA)

• Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)

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New IRP Marketing Authorisation Applications (MAAs)

The IRP pathway is open to a wide range of product types, including new active substances, generic medicines, hybrid applications, biosimilars, fixed-dose combinations, additional strengths, and line extensions. To be eligible, the medicinal product must already be authorised or have been recommended for approval by one of the designated RRs.

Applicants must submit a complete dossier to the MHRA, along with assessment reports from the RR and the corresponding product information, such as the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labelling. The MHRA aims to review new active substances within 60 days, while generics and biosimilars are targeted for review within 45 days, provided that the submissions are complete and meet quality standards.

Post-authorisation IRP Applications: Variations and Renewals

The IRP is not limited to new authorisations. It also supports post-authorisation lifecycle management, including the submission of variations (whether major or minor) and renewals that have already been assessed and approved by an RR. These applications must reference the RR’s decision, and companies must include supporting documentation such as assessment reports and any updated product information. The MHRA will still conduct a focused review to ensure the RR's decision applies to the GB market, especially when considering safety data or labelling requirements specific to the UK.

Applications using the IRP must be submitted through the MHRA’s Submission Portal. When applying, applicants should select IRP as the preferred regulatory route and include a cover letter justifying the eligibility for IRP.

Although the IRP is built on the principle of reliance, the MHRA retains its sovereign decision-making authority. This means that additional national requirements may still apply. For example, MHRA may request GB-specific information related to pharmacovigilance, manufacturing, or distribution. Furthermore, product labelling must comply with UK-specific labelling standards.

Applications submitted under the IRP are subject to fees, which are defined in the UK’s Human Medicines Regulations 2012. These fees vary depending on the type of procedure (e.g., MAA, variation, or renewal) and are due at the time of submission.

For more details about the International Recognition Procedure, click this LINK