From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP.
ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices. For ECDRP applications, the Committee for Medicinal Products for Human Use (CHMP) positive opinion (but not necessarily the European Commission Decision) should be received before 31 December 2023.
IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs). A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP.
The same product is defined as having the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, from Applicants belonging to the same company or group of companies or which are ‘licensees’.
IRP will allow the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The MHRA will conduct a targeted assessment of IRP applications but retain the authority to reject applications if the evidence provided is considered insufficiently robust.
IRP can be used for the following types of marketing authorisation applications (MAAs) according to the Human Medicines Regulations 2012 (HMRs):
- Regulation 50: chemical and biological new active substances and known active substances.
- Regulation 51, 51A and 51B: generic applications
- Regulation 52, 52A and 52B: hybrid applications
- Regulation 53, 53A and 53B: biosimilar applications
- Regulation 55: new fixed combination product applications
Traditional Herbal Registrations, Homoeopathic Registrations (Simplified Registration Scheme) and Homeopathic National Rules Authorisations (National Rules Scheme) are excluded from IRP. Bibliographic applications (Regulation 54 of the Human Medicines Regulations) are also not eligible.
IRP can also be used for post-authorisation procedures including line extensions, variations and renewals (see Product lifecycle).
The RR assessment must have undergone a full and standalone review. RR assessments based on reliance or recognition cannot be used to support an IRP application.
Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval) can support an IRP application. Emergency approvals are not eligible.
Until the Windsor Framework is implemented in Northern Ireland on 1 January 2025, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain.
Reference Regulators (RRs)
Acceptable RRs are shown in the table below.
| Country or Jurisdiction | Regulatory Authority |
|---|---|
| Australia | Therapeutic Goods Administration (TGA) |
| Canada | Health Canada |
| Switzerland | SwissMedic |
| Singapore | Health Science Authority Singapore (HSA) |
| Japan | Pharmaceuticals and Medical Devices Agency (PMDA) |
| United States | Food and Drug Administration (FDA) |
| European Union/European Economic Area | European Medicines Agency (EMA) and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein. (This includes approvals through the centralised, MRP/DCP and individual member state national routes) |
Access Consortium approvals that did not include MHRA as part of the work-sharing procedure can be used for IRP. The Applicant may choose one of the trusted regulators within the Access Consortium as the RR and submit the relevant documents as approved by that specific regulator (see How to apply).
Recognition A and B
There are two recognition timetables for initial MAAs:
- Recognition A: 60-day timetable
- Recognition B: 110-day timetable
The timetables are calendar days and start once the IRP submission has been validated by MHRA.
Suitability for Recognition A or B is determined by means of an eligibility form to be completed by the Applicant 6 weeks before the planned date of MAA submission (see under section ‘How to apply’).
Applications that are determined not eligible for Recognition A or B can be submitted as full national applications if MHRA requirements are met.
Key features of Recognition A:
To be eligible for Recognition A, the RR approval must have been granted within the previous 2 years. A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP.
The manufacturing process must be the same as that approved by the RR, with evidence of compliance with Good Manufacturing Practice (GMP) at the time of IRP submission.
The Recognition A route will be open to applications that meet the criteria for IRP and do not meet any of the Recognition B criteria (see below).
Recognition A procedures will run to a 60-day timetable from validation, with no clock stop. However, if Major Objections are identified which cannot be resolved within 60 days, the timetable may revert to Recognition B.
Key features of Recognition B:
To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years. A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP.
IRP applications will follow Recognition B if any one of the following criteria applies:
- RR has granted a conditional or exceptional circumstances MA (or international equivalent).
- A conditional or exceptional circumstances MA is sought in UK/GB.
- Additional manufacturing sites are cited that have not been assessed by the RR (except for secondary packaging, labelling and QP release sites).
- There are substantial changes in the manufacturing process or analytical methods compared to what was assessed by the RR.
- At least one manufacturing site is not yet GMP certified.
- The Environmental Risk Assessment (ERA) has not been assessed by the RR.
- The Risk Management Plan (RMP) has not been assessed by the RR.
- There are UK-specific risk management activities (e.g., which may be reflected as additional pharmacovigilance or additional risk minimisation activities).
- The RR has mandated one or more post-authorisation safety studies (PASS).
- The product contains a first-in-class new active substance.
- The product incorporates novel or cutting-edge technologies.
- Clinical efficacy or safety data are available for a later cutoff than those assessed by the RR.
- The pivotal clinical data are from single arm studies.
- The pivotal clinical data include real world data.
- Advanced therapy medicinal product (ATMP) as classified by the HMRs 2012.
- Fractionated plasma product.
- Application for orphan drug designation.
- Comparator product used in bioequivalence or therapeutic equivalence study was sourced outside the UK/EU/EEA (generic/hybrid applications).
- Product is not subject to medical prescription.
- Co-packaged medical device components are not CE or UKCA marked.
- Where an IVD is required for correct use, the IVD is not CE or UKCA marked.
- An approved body or notified body report is not available for integral medical device components.
- The RR assessment cites guideline(s) that are not adopted by the MHRA.
- Proposed container closure system, shelf-life or storage conditions differ compared to those accepted by the RR and/or additional stability studies have been provided to MHRA.