Last updated: 4 April 2025
The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024.
This post is an attempt to present the information in a Q&A format. The information is by no means the complete information as presented on the MHRA website.
Always read the guidance on this procedure published on the MHRA website for the most up to date information and complete information.
Click on the ‘+’ sign next to each heading to access the information under each heading.
| Date | Update(s) |
|---|---|
| 4 April 2025 | Post updated in line with information on the MHRA website. |
| 29 Aug 2024 | New section ‘MHRA updates’ added and populated with available information. Deleted the following sections: –Further information –Supplementary Information –eCTD guidance for IRP MAs and Lifecycle |
| 8 Apr 2024 | i) New section Supplementary Information added. ii) New section eCTD guidance for IRP MAs and Lifecycle added. |
| 10 Jan 2024 | New section What will happen to the ECDRP and MRDCRP procedures once the IRP becomes operational on 1 January 2024? added. |
| 3 Jan 2024 | 1) New section Is a pre-submission meeting required for IRP applications? added. 2) New section When should a scientific advice meeting be requested? added. 2) Administrative changes made to improve readability |
| 2 Jan 2024 | 1) Section entitled When will the IRP become operational ? updated to included link from the MHRA website confirming that the IRP has gone live from 1 Jan 2024. 2) Section entitled Which licensing procedures will be incorporated under the umbrella of the IRP? updated to clarify that the MRDCRP procedure will be incorporated under the umbrella of the IRP from 1 January 2024. |
| 21 Dec 2023 | In the section Further Information, added a link to the MHRA webinar of 29 November 2023. |
| 8 Dec 2023 | Section What is the purpose of having two recognition routes (A and B) and which application types are eligible? added. |
| 2 Dec 2023 | Administrative updates to improve readability. Entire post updated to an accordion format plus other minor administrative changes to improve readability. |
| 20 Nov 2023 | Updated post (as shown below) in line with updated guidance published on 20 Nov 2023 the MHRA website plus added other changes using the information that was already on the website prior to the latest update of 20 Nov 2023. 1) Heading What does ‘same product’ mean? plus relevant content added. 2) Added information on Well established use products under the heading Which Marketing Authorisation Applications types will not be eligible for the IRP? 3) Added heading Licensing products falling within the scope of the EU centralised procedure plus relevant content. 4) Section How will suitability for Recognition A or B be determined? updated with further information on the eligibility checker. 5) All occurences of ‘eligibility form’ updated to ‘eligibility checker’ or ‘eligibility checker form’. 6) Added heading Basic requirements for IRP applications plus relevant content. Under the sub-heading How should you submit your IRP application?, updated the application types. 7) Updated the content under the heading Submission of an IRP as an electronic Common Technical Document (eCTD) 8) Added heading Submitting your IRP Variation or Renewal plus relevant content. 9) Updated information under the heading Information that must be included in the cover letter accompanying an IRP application 10) The Fees section has been updated to confirm that the MHRA fees page has been updated to include the fees for the International Recognition Procedure. |
The MHRA has created an international recognition route for medicines licensing utilising pre-existing approvals from the following countries/region):
- Australia
- Canada
- the European Union
- Japan
- Switzerland
- Singapore
- United States
This new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners.
The International Recognition Procedure became operational from 1 January 2024 and sits alongside the MHRA’s current national procedures.
Once the IRP became operational on 1 January 2024, It replaced the the EC Decision Reliance Procedure (ECDRP).
From 1 January 2024, the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) was incorporated under the umbrella of IRP.
The IRP is open to applicants that have already received an authorisation for the same product (see definition below) from one of MHRA’s specified Reference Regulators (RRs) listed below under the heading Which regulatory agencies are acceptable Reference Regulators (RRs) for the purposes of the IRP. A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP.
What does ‘same product’ mean?
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’.
The acceptable Reference Regulators RRs are listed in the table below:
| Country or Jurisdiction | Regulatory Authority (also known as Reference Regulator for the purposes of the IRP) |
|---|---|
| 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 Medicines Agency (EMA) and Member State Competent Authorities (This includes approvals through the centralised, MRP/DCP and individual member state national routes) |
The IRP allows 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.
The following types of marketing authorisation application (MAA) according to the Human Medicines Regulations 2012 (HMRs) are allowed under the IRP
| Regulation according to the Human Medicines Regulations 2012 (HMRs) | Marketing Authorisation Application type |
|---|---|
| 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 |
- Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval) can support an IRP application.
- Bibliographic applications (Regulation 54 of the Human Medicines Regulations) are not eligible for the IRP
- Well established Use applications are excluded from IRP because they rely on documentation to demonstrate that the active substances of the product have been in well-established medicinal use within the UK or EU for at least 10 years, with recognised efficacy and an acceptable level of safety. As clinical practice and healthcare systems differ in different jurisdictions, the evidence used to support an authorisation from a RR may not support use in the UK.
- The RR assessment must have undergone a full and standalone review.
- Conditional and exceptional circumstances MAAs (or international equivalent such as provisional or accelerated approval) can support an IRP application.
- Access Consortium approvals that did not include MHRA as part of the work-sharing procedure can be used for IRP. You may choose one of the trusted regulators in the Access Consortium as the RR and submit the relevant documents as approved by that specific regulator
- RR assessments based on reliance or recognition cannot be used to support an IRP application.
- Emergency approvals are not eligible.
- You cannot use cancelled authorisations to support an IRP application
No, a pre-submission meeting (PSM) is not required for IRP applications.
The MHRA has published detailed eCTD guidance in addition to the main IRP guidance. Applicants are advised to study these guidelines before requesting a PSM. Specific questions relating to IRP can be sent to the MHRA via RIS.NA@mhra.gov.uk.
A scientific advice meeting should be requested for scientific or technical questions,
Yes, Access Consortium approvals that did not include the MHRA as part of the work-sharing procedure can be used for the IRP. The Applicant may choose one of the trusted regulators within the Access Consortium as the Reference Regulator (RR) and submit the relevant documents as approved by that specific regulator.
Yes, the IRP may also be used for post-authorisation procedures including:
- line extensions,
- variations (Type IB, Type II).
- renewal applications (including annual renewal of conditional MAs and annual reassessment of exceptional circumstance MAs)
- submission Type IA variations if they are part of a group with Type IB or Type II variations.
IRP can be used during the lifecycle of products that have been initially authorised or subsequently varied via standalone national routes. Conversely, where a product has been authorised via IRP, it is acceptable to submit standalone national post-authorisation procedures including variations.
- Variations submitted via IRP should be classified according to MHRA Guidance on Variations to MAs.
- To facilitate lifecycle management of the MA, variations should be submitted as soon as possible after approval by the RR.
- The MHRA retains the authority to reject a variation application if the evidence provided is considered insufficiently robust.
- Variations which impact on patient safety will be assessed in the context of the UK clinical situation and the MHRA may require assessment through a national route where there are specific UK considerations.
- Where you intend to use the IRP to vary your MA with new information that might impact evaluation of the benefits and risks of a product, clinical management of patients, and/or require proactive communications, you should send the information to the MHRA as soon as possible, together with your proposals at: safetyprojects@mhra.gov.uk.
- The MHRA will then inform you if you can submit the variation via IRP once the RR assessment has concluded or whether you need to submit via a national procedure.
- Failure to inform the may result in you being requested to submit an urgent national variation.
- In order to use IRP for renewals (including the annual renewal of conditional MAs and annual reassessment of exceptional circumstance MAs), applications can be delayed until the reference regulator assessment is completed and the decision available to be included with your submission.
- The MA will remain valid and you should submit the application to MHRA as soon as possible, and no later than 60 days following the final assessment being available from the reference regulator.
- However, in the event that the reference regulator makes a recommendation at any point during their assessment (whether provisional or final) that the balance of benefits and risks is no longer favourable, there must be no delay in notifying MHRA of this information.
- As with other lifecycle changes, you are expected to use the original RR for renewal applications.
- Applicants are reminded of the obligation to notify MHRA as soon as reasonably practicable, of any information that might influence the evaluation of the benefits and risks of an authorised product.
- IRP is not a substitute for MAH’s obligations to submit pharmacovigilance data and information to the MHRA and to keep the MA up to date with current scientific knowledge.
There are two recognition timetables for initial MAAs:
- Recognition route A: 60-day timetable
- Recognition route B: 110-day timetable
The timetables are calendar days and start once the IRP submission has been validated by MHRA.
It is important to note the following:
- ATMPs are eligible for Recognition B only. Due to potential differences between guidelines internationally, some IRP applications may require additional checks by MHRA.
- IRPs that include GB orphan drug designation applications will not be eligible for Route A
- If the RR has not assessed the Risk Management Plan (RMP), the product will be eligible for Recognition B only.
- In the case that the RR has assessed an RMP, but the RMP proposed for UK/GB is not the same or not in the same format as the RMP approved by the RR, the product will be eligible for Recognition B only.
- If a new site is added specifically for the MHRA, the application is eligible for Recognition B only.
The purpose of having two routes is to enable fast approval of those IRP applications which require limited assessment.
Recognition A and B only apply to initial marketing authorisations and line extensions.
How will suitability for Recognition route A or B timetable be determined?
The MHRA has made available an online Eligibility checker.
- The Eligibility Checker should only be completed for Initial MAAs (including line extensions).
- Suitability for Recognition rote A or B is determined by means of an online Eligibility Checker to be completed by the Applicant 6 weeks before the planned date of MAA submission.
- Before filling in the Eligibility Checker please make sure you have read the guidance on IRP.
- The form will ask a series of questions that enables the MHRA to identify the appropriate IRP Route A or B. In a small number of cases, it will require triage by the MHRA to reach a conclusion on this route.
- Some points worth noting:
- To be eligible for Recognition A, the RR approval must have been granted within the previous 2 years.
- To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years.
- If your application is older than 10 years you may still be eligible, but you will need to check with the MHRA before filling in the Eligibility Checker.
- Once you have completed the form and downloaded it, follow the submission instructions at the top of the form.
Further guidance on the Eligibility Checker and submitting your Marketing Authorisation application is available here.
Applications that are determined not eligible for Recognition A or B can be submitted as full national applications if MHRA requirements are met.
- To be eligible for Recognition A, the Reference Regulator (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 .
- 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.
The Recognition A criteria have been chosen to allow a limited MHRA assessment in most cases.
- 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.
- Recognition B procedures will run to a 110-day timetable from validation to allow for consultation with the Commission on Human Medicines (CHM). Submission dates for Recognition B to align with CHM dates for New Active Substances (NAS) will be published in due course.
- Recognition B includes one clock stop at day 70, allowing the Applicant up to 60 days to respond to any issues identified. If there are outstanding Major Objections at Day 110, formal advice on approvability will be sought from CHM, and the timetable will revert to the national 210-day timetable.
The assessment timeline for Recognition B is 110 calendar days. The MHRA assessment will be targeted.
- However, there are aspects of Recognition B applications that are likely to require additional assessment and/or inspection activity. There is the option for the MHRA to send a request for further information and stop the clock at Day 70.
- The clock-stop is up to 60 calendar days to allow the applicant to prepare responses. The applicant can request an extension of the clock-stop.
All IRP applications must meet the following basic application criteria:
- The product in question is classified as a medicinal product under current legislation and MHRA guidance. How other regulators define a medicinal product in their jurisdiction is of no consequence for IRP applications.
- The Reference Regulator’s (RR’s) assessment package is to be complete, in English and unredacted except for personal information
- The company or authorised representative must be established in the UK, i.e. Great Britain or Northern Ireland, or in the EU/EEA.
- The RR’s assessment relates to a de novo standalone evaluation for a full marketing authorisation, conditional marketing authorisation, or a marketing authorisation under exceptional circumstances (or international equivalents). It cannot be based on a reliance approval. Emergency approvals are not included in IRP.
About the applicant
The application must satisfy the following conditions:
- The Applicant/MAH must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA.
- It is anticipated that the Applicant for an IRP application is the same company or belongs to the same (legal) group of companies as the MAH of the RR procedure. This is to ensure that the Applicant/MAH can fulfil the submission requirements as well as all their legal obligations as holder of an MA, such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).
- Provided an Applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept applications from third parties.
The requirement for a PL number before completion of the eligibility checker
A product licence (PL) number is required before completion of the eligibility. If you do not have a 5-digit company number, to allow registration on the MHRA Submissions Portal, this should be requested from Reference.Data@mhra.gov.uk. A PL number can then be obtained through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk.
The eligibility checker (for inital MAAs only including line extensions)
Suitability for Recognition A or B will be determined by means of an online eligibility checker to be completed by the Applicant 6 weeks before the intended date of MAA submission.
When and how to submit the eligibility checker form:
A table is provided on this page indicating when and how to submit the completed eligibility checker form.
- The form should be included in module 1.2 of the eCTD and
- the cover letter should indicate which recognition route (A or B) and RR you are using.
- The eligibility checked should be emailed to Recognition@mhra.gov.uk at least 6 weeks before the intended date of IRP submission.
If you are notified that your application is unsuitable for the IRP, do you have other options?
If you are notified that your application is not suitable for IRP, you can submit an MAA via the national route if MHRA requirements are met.
For a national route application, you should request a pre-submission meeting 3 months prior to planned submission if your product contains a new active substance.
Submission of an Initial Marketing Authorisation
You should submit your application through the Human Medicines Portal. No other submission route is acceptable for IRP.
When submitting your initial IRP application, you will be asked to indicate whether your application is:
- Initial Marketing Authorisation NAS – IR Route A
- Initial Marketing Authorisation NAS – IR Route B
- Initial Marketing Authorisation – IR Route A
- Initial Marketing Authorisation – IR Route B
As per the current functionality, you will need to indicate whether your submission is:
- Original submission
- Validation Correction Request (VCR)
- Response to questions
Submission of an IRP as an electronic Common Technical Document (eCTD)
You should submit an IRP application to MHRA as one electronic Common Technical Document (eCTD) sequence through the MHRA Submissions Portal.
- The eCTD should be in EU format with a UK-specific module 1. You must include certain information in the cover letter (as detailed on this webpage). See further guidance on the eCTD module 1 requirements for IRP.
- The eCTD submission should be aligned with the consolidated dossier as reviewed by the RR, including the applicant’s full responses to RR questions.
- You should include approved post-authorisation changes, including variations with the MHRA MAA submission once approved by the RR.
- 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
What documentation should a submission for a post-authorisation IRP application include?
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 where available, you must provide it
- the final product information (or international equivalent) and/or updated risk management plan approved by the RR if applicable
- Where EMA is the RR, a CHMP positive opinion letter is sufficient documentation of approval. Applicants should not submit their IRP applications until they have received the CHMP positive opinion and agreed final product information. For MR-DC recognition, a positive end-of-procedure (EoP) letter is sufficient documentation of approval.
Some important points to note prior to submitting an IRP application
- All RR documents submitted in support of an IRP application to MHRA must be in English. A certified translation (verified translation may be acceptable) should be provided for any original documents that are not in English. If a translation is submitted, the Applicant must confirm in writing that it is correct.
- It is your responsibility to provide the requested documentation. It is not the responsibility of the RR to provide any documentation to the MHRA.
- A pre-submission meeting (PSM) is not required for IRP applications. However, you may request a pre-submission meeting to discuss the IRP dossier and requirements, and procedural or regulatory issues. For scientific or technical questions, a scientific advice meeting should be requested.
Information that must be included in the cover letter accompanying an IRP application
The information that must be included in the cover letter for an initial and post-authorisation application is different and you can find the necessary information on this page.
Information on specific requirements is provided below:
Orphan Drug Designation
IRPs that include GB orphan drug designation applications will not be eligible for Route A. See further information on orphan drug designation application.
Paediatric requirements
For submissions that will trigger paediatric requirements, applicants should ensure the latest UK Paediatric Investigation Plan (PIP) / waiver opinion / decision or class waiver decision, and the compliance check outcome documents, are included in the IRP application dossier.
If paediatric requirements are triggered in any other jurisdiction, the latest PIP/Paediatric Study Plan (PSP)/waiver opinion/decision or class waiver decision should be submitted to the MHRA Paediatrics Team as part of the UK-PIP submission.
Further information can be found here.
Risk Management Plan (RMP)
The RMP must meet MHRA requirements and follow the EU RMP template. Where appropriate, the format of GB/UK-specific RMP annex + approved EU RMP is also acceptable. Please read the guidance on this page for further information on the required format of the RMP.
If paediatric requirements are triggered in any other jurisdiction, the latest PIP/Paediatric Study Plan (PSP)/waiver opinion/decision or class waiver decision should be submitted to the MHRA Paediatrics Team as part of the UK-PIP submission.
Further information can be found here.
Advanced therapy medicinal products (ATMPs)
ATMPs are eligible for Recognition B only.
Environmental Risk Assessment
The ERA needs to have been assessed by the reference regulator for the product to be eligible for Recognition A. If the ERA has not yet been assessed by an RR, the product will be eligible for Recognition B only.
Good manufacturing practice (GMP)
The Applicant will need to confirm that all manufacturing sites have a current GMP certificate that meets MHRA requirements.
If a new site is added specifically for the MHRA, the application is eligible for Recognition B only.
If the site in question has no relevant inspection history, the timelines for the Recognition process may be extended until an inspection has been successfully completed.
Where available, inspection information from Mutual Recognition Agreement (MRA) partners and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating authorities should be submitted to support verification of the GMP status of manufacturing sites based in third countries. This information will be utilised in accordance with the principles of Inspection Reliance
Nitrosamine risk assessment
Before the Recognition procedure for a new product can be approved, the Applicant must provide a nitrosamine risk assessment in line with MHRA guidance. Please see the following link for more information: Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
Generic and biosimilar applications
The proposed indications and posology must be in line with the UK Reference Product.
Applicants should ensure that there is no infringement of data and market exclusivity (DME).
In the case of generic or hybrid medicines, if the comparator product used in the bioequivalence or therapeutic equivalence study was not sourced from the UK/EU/EEA market, reference should be made to the MHRA guidance on comparator products in bioequivalence and therapeutic equivalence studies:
Until the Windsor Framework is implemented on 1 January 2025, if the comparator product is not sourced from the UK/EU/EEA market, the generic or hybrid medicine can only be authorised in Great Britain.
See MHRA’s guidance for biosimilars.
Other specific information
Information on the following is provided on this page:
- Plasma Products
- Compendial requirements
- Active Substance Master Files (ASMF)
Active Substance Master File (ASMF)
- If an ASMF has been submitted to the reference authority for the application in question, the ASMF holder must submit an identical copy of the complete ASMF (Applicant’s and Restricted Parts) to MHRA.
- Modules 2.3 and 3 must be submitted in consolidated form together with relevant sections of Module 1 according to MHRA requirements that includes the Letter of Access, the Assessment Report from the Restricted Part, the List of Questions and the response of the ASMF holder to the Restricted Part.
- If the ASMF has been subsequently modified (i.e. after first authorisation abroad and before submission to MHRA), the approved variations, with the corresponding assessment reports, must be submitted separately in parallel and noted in the cover letter together with a comparison showing the changes (old / new).
eCTD guidance for marketing authorisation and post-authorisation applications for IRPs is available here.
The information is presented in two main section :
- New IRP marketing authorisation applications (MAAs)
- IRP post-authorisation applications: variations and renewals
You can find out more about the fees we charge in the guidance MHRA fees.
Use the Fees calculator to work out what the fee for your submission will be.
The Reference regulator document lists on this page show the documents that comprise a complete assessment for each Reference Regulator (RR).
- You must submit the full set of documents in your application.
- All RR documents submitted in support of an IRP application to MHRA must be in English.
- You should provide a certified translation (verified translation may be acceptable) for any original documents that are not in English.
- If submitting a translation, you must confirm in writing that it is correct.
You can view an MHRA webinar on the IRP held on 14 September 2023 at this link, or the webinar held on 29 November 2023 at this link.
MHRA webinar of 14 September 2023 at this link,
This webinar, provided by the MHRA [00:08], discusses international recognition (IRP).
Here are the key points covered:
- The international context of IRP [01:30]
- The features of recognition A and B [01:30]
- PV considerations [01:40]
- How to apply for an MA via an IRP [01:48]
- Product life cycle variations and recognition [01:48]
Key takeaways from the webinar include:
- IRP allows medicines to reach the UK market faster [02:07].
- The framework increases capacity and strengthens international partnerships [02:29].
- The MHRA aims to deliver predictability and reliability [03:26].
- IRP is aligned with other regulators’ practices [05:53].
- IRP is offered alongside existing national licensing routes [08:18].
- It is open to applicants with authorization from a reference regulator [08:40].
- The MHRA will conduct a targeted assessment based on the reference regulator’s reports [09:11].
- Recognition A has a 60-day timetable, while recognition B has a 110-day timetable [11:11].
- The eligibility form helps determine the appropriate route [12:48].
- Risk management plans must follow EU RMP templates [16:41].
- Existing UK pharmacovigilance requirements still apply [18:07].
- Applications are submitted via the MHRA submissions platform [20:28].
- eCTD must follow the EU format [23:49].
You can view the MHRA webinar of 29 November 2023 at this link.
This webinar provided an update on the International Recognition Procedure (IRP) and its launch on January 1, 2024 [01:25]. The MHRA is offering this procedure alongside its national licensing routes [05:50].
Here’s a breakdown of the key topics covered:
- Overview of the IRP:
- The IRP allows applicants who have already received authorization from a trusted reference regulator to obtain UK approval through a streamlined process [06:30].
- The MHRA will conduct a targeted assessment based on the reference regulator’s assessment reports [07:00].
- The IRP covers most product types, excluding traditional herbal, homeopathic products, and bibliographic well-established use applications [07:18].
- Recognition A vs. Recognition B:
- There are two routes for initial marketing authorization applications and line extensions: Recognition A (60 calendar days) and Recognition B (110 calendar days with a potential clock stop) [07:59].
- Recognition A is for applications where the reference regulator approval is within two years and the manufacturing process is essentially the same [10:10].
- Recognition B applies to a broader range of scenarios, including approvals within the past 10 years, conditional MAs, and applications with significant differences compared to the reference regulator’s assessment [10:41].
- Risk Management Plans (RMP):
- Pharmacovigilance:
- UK national pharmacovigilance requirements apply, including those for individual case safety reports and PSURs [13:29].
- Product Lifecycle:
- The IRP covers the product lifecycle, with existing timeframes applying except for line extensions, which follow Recognition A or B [14:41].
- Eligibility Form:
- How to Apply:
- eCTD Guidance:
- Updated guidance is available on the MHRA website, detailing the content and format requirements for ECTD submissions for both initial applications and variations/renewals [25:09].
- Fees and Key Performance Indicators (KPIs):
- Updated Guidance:
- The MHRA has published supplementary information and guidance on the eligibility checker, product lifecycle applications, and ECTD submissions [29:26].
Source: MHRA