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MHRA International Recognition Procedure

June 14, 2026

Purpose

To expedite the approval & availability of safe and effective medicines authorised by trusted regulators (Reference Regulators – see list below) to patients in the UK, while maintaining MHRA’s independent oversight.

Reference Regulators (RRs)

  • Therapeutic Goods Administration (TGA), Australia
  • Health Canada, Canada
  • SwissMedic, Switzerland
  • Health Science Authority (HSA), Singapore
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Food and Drug Administration (FDA), United States
  • European Medicines Agency (EMA)
  • Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein[1]

Evolution Timeline

Period

Key Change

Regulatory Scope

Pre‑Brexit (≤ 2020)

EMA approvals applied across UK[2]

Unified EU + UK system

During Brexit Transition (2021–2023)

MHRA introduced ECDRP

GB[3] only; NI under EU

IRP Launch (Jan 2024)

Replaced ECDRP with IRP (EMA CHMP opinions accepted)

GB only

Post Windsor Framework (Jan 2025 →)

UK‑wide MHRA authorisations

Across UK

EU – European Union; MHRA – Medicines & Healthcare Products Regulatory Agency; ECDRP – EC Decision Reliance Procedure; CHMP – Committee for Medicinal Products for Human Use

IRP route is open to applicants that have already received an authorisation for the same product[4] from one of the specified RRs. For the purposes of IRP, a CHMP positive opinion or an MRDC positive end of procedure outcome is considered an RR authorisation.

Applications in scope

  • Chemical and biological new active substances and known active substances.
  • Generic applications
  • Hybrid applications
  • Biosimilar applications
  • New fixed combination product applications
  • Post-authorisation procedures – line extensions, variations & renewals

Applications NOT in scope

  • Traditional herbal registrations
  • Homoeopathic registrations (Simplified Registration Scheme) and homeopathic national rules authorisations (National Rules Scheme)
  • Bibliographic applications
  • Well established use (WEU) applications

Other key considerations

  • The RR assessment on which IRP is based, must have undergone a full and standalone review. 
  • Cannot use an RR assessment which itself is based on a reliance or recognition procedure.
  • Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval) can support an IRP application.
  • Emergency approvals are not eligible.
  • Cannot use a cancelled authorisation to support an IRP application.
  • Module 3 needs to refer to BP or Ph. Eur. compendial standards. The drug substance, excipients and finished product must comply with these standards, if tested.
  • For biosimilars and generics, applicants must ensure –
    • compliance with data periods specified in the HMRs 2012[5], and
    • that the reference product cited in the application form complies with the definition of a reference product as per the HMRs 2012.

IRP Recognition Routes - New Marketing Authorisation Applications

Route

Timeline

Conditions

Recognition A

60 calendar days from validation
  • RR approval within previous 2 years.
  • Manufacturing process must match the RR-approved process, with GMP compliance evidence.
  • Open to applications that meet IRP criteria & do not meet any of the Recognition B criteria.
  • No provision for clock stop.
  • If major objections are identified which cannot be resolved within 60 days, the timetable may revert to Recognition B.

Recognition B

110 calendar days from validation
  • RR approval within previous 10 years[6].
  • Adopted if any of the criteria listed at the GOV.UK IRP page are met e.g.,-
    • additional manufacturing sites are cited that have not been assessed by the RR.
    • There are substantial changes in the manufacturing process or analytical methods compared to that assessed by the RR.
    • At least one manufacturing site is not yet GMP certified.
    • The product contains a first-in-class new active substance.
    • The pivotal clinical data are from single arm studies.
    • The pivotal clinical data include real-world data.
    • Advanced Therapy Medicinal Products (ATMPs).
    • Application for orphan drug designation.
    • Comparator product used in bioequivalence or therapeutic equivalence study was sourced outside the UK/EU/EEA (generic/hybrid applications).
    • An approved body or notified body report is not available for integral medical device components.
    • Proposed container closure system, shelf life or storage conditions differ from those accepted by the RR and/or additional stability studies have been provided to MHRA.
  • One clock stop at day 70, with up to 60 calendar days for the applicant to respond>[7].
  • If there are major outstanding objections at day 110, formal advice on approvability is sought from CHM and the timetable will revert to the national 210-day timetable.

CHM – Commission on Human Medicines

Both IRP routes are substantially shorter than the 210-calendar day timetable for a national MA application.

Suitability for Recognition A or B is determined by means of an online eligibility form to be completed by the applicant 6 weeks before the planned date of MAA submission.

When and how to submit the eligibility form?

Condition

Action

Product is a new active substance and the completed form indicates suitability for Recognition A or B

Submit the form directly to Recognition@mhra.gov.uk at least 6 weeks before the intended date of MAA submission.

Product is not a new active substance and the completed form indicates suitability for Recognition A or B

Submit the form along with the MAA application.

The completed form indicates that it requires triage by MHRA

Submit the form directly to Recognition@mhra.gov.uk at least 6 weeks before the intended date of MAA submission.

Post-authorisation IRP applications: Variations and Renewals

  • Applicable for line extensions, variations (Type 1B, Type II) and renewals. Type 1A variations may be submitted if approved by RR grouped with Type 1B or Type II variations.
  • Applicable for products that have been initially authorised or subsequently varied via standalone national, MRDCRP (Mutual Recognition/ Decentralised Reliance Procedure) or ECDRP routes.
  • IRP route can be availed after RR approval.
  • Should submit the application to MHRA as soon as possible, and no later than 60 days following the final assessment being available from RR.
  • Generally recommended to use same RR for IRP applications throughout the product lifecycle, unless justified on patient benefit grounds.
  • Recognition routes A and B is only applicable for new IRP MAAs and line extensions.

For new IRP MAAs, the submission should include:

  • Documentation of the RR’s approval decision.
  • All available iterations of the RR’s assessment reports for the initial authorisation and any major post-authorisation procedures (for example, significant variations, renewals).
  • The final product information (or international equivalent) approved by the RR.
  • A list of differences (other than formatting) between the dossier approved by the RR and that submitted to MHRA.

For post-authorisation IRP applications (including variations), the submission should include:

  • Documentation of the RR’s approval decision.
  • All iterations of the RR’s assessment reports for the relevant post-authorisation procedure - note that an RR assessment report may not be needed for all Type IB variations, but provided where available.
  • The final product information (or international equivalent) and/or updated risk management plan approved by the RR (if applicable).

The complete list of RR documents for new IRP MAA is available at International Recognition Procedure - GOV.UK.

Key Takeaways

  • IRP offers the fastest UK route when leveraging EMA or other trusted RR approvals.
  • Recognition A (60 days) is ideal for straightforward cases; Recognition B (110 days) covers complex scenarios.
  • MHRA conducts targeted assessment; retains discretion to reject.
  • UK-wide licensing under Windsor Framework simplifies lifecycle management.
  • Strategic use of IRP enables synchronised EU–UK submissions, strengthening regulatory agility post-Brexit.

Sources

Footnotes

  1. This includes approvals through the centralised, MRP/DCP and individual member state national routes. ↑

  2. United Kingdom (UK) – includes England, Scotland, Wales & Northern Ireland (NI) ↑

  3. Great Britain (GB) – includes England, Scotland & Wales ↑

  4. Product having same qualitative & quantitative composition (active substance(s) and excipients), same pharmaceutical form, from Applicant(s) belonging to the same company or group of companies or which are ‘licensees’. ↑

  5. The Human Medicines Regulations 2012 ↑

  6. In exceptional circumstances, approvals older than 10 years may be acceptable, e.g. in case of supply shortages for certain products.↑

  7. The applicant can request an extension of the clock-stop. ↑

Disclaimer

This information is provided for educational purposes only and should not be considered as legal or regulatory advice. Always consult with qualified regulatory professionals for specific guidance. We welcome your perspectives — please share your thoughts at vivek@astarregsol.com.