The MHRA has issued detailed guidance on the new International Recognition Procedure which will allow pharmaceutical companies with overseas medicines approvals to fast-track their application for UK marketing authorisations.

The IRP will be available from 1 January 2024 to marketing authorisation holders (MAHs) with approvals granted in:

•  Australia
• Canada
• European Union
• Japan
• Switzerland
• Singapore
• United States

The IRP was announced in May (see our previous blogpost) and will replace the temporary EC Decision Reliance Procedure (ECDRP), which was put in place following the UK’s exit from the EU and is due to end on 31 December 2023. It will provide an important route for pharmaceutical companies looking to bring products to market in the UK.

The new IRP guidance contains details of the scope of the IRP, the applicable overseas regulators, two different timetables for applying for recognition, the application process, national requirements and fees. We have summarised some of the key points below.  

Scope of IRP

The IRP will be available to applicants that already have an authorisation for the same product from one of the specified regulators. For the purposes of the IRP, the same product is defined as:

• Having the same qualitative and quantitative composition;
• Having the same pharmaceutical form; and
• Being produced by applicants belonging to the same company/group of companies or which are ‘licensees’.
• The IRP will also incorporate The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) for EU member states to create a streamlined process by which medicines from international producers reach UK patients.

Under the IRP, the MHRA will be able to take into account the expertise and decision-making of trusted regulatory partners when deciding whether to grant a UK authorisation on the basis of an overseas approval. Ultimately the MHRA will still have discretion to approve or reject any applications under the IRP and a separate UK authorisation will still be required to market products in the UK.

As well as replacing the ECDRP, the IRP will also incorporate The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP). ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing schemes.

Which applications does this cover?

Conditional and exceptional circumstances applications (or international equivalent such as provisional or accelerated approval) can support an IRP application. Emergency approvals are not eligible.

IRP will be applicable to the following marketing authorisation applications:

• Chemical and biological new active substances (Regulation 50)
• Generic applications (Regulation 51, 51A and 51B)
• Hybrid applications (Regulation 52, 52A and 52B)
• Biosimilar applications (Regulation 53, 53A and 53B)
• New fixed combination product applications (Regulation 55)

However, the following are either excluded or ineligible:

• Traditional Herbal Registrations, Homoeopathic Registrations (Simplified Registration Scheme)
• Homeopathic National Rules Authorisations (National Rules Scheme)
• Bibliographic applications (Regulation 54 HMR)

Applicable overseas regulators 

The table below lists the relevant regulatory authorities for different countries from whom the applicant must already have authorisation to apply through the IRP.

Recognition A and B

There are two recognition timetables for MAAs, with the shorter timeframe available to more recent and straightforward applications. Applicants must complete an eligibility form 6 weeks before the planned date of their IRP application submission to determine which recognition timetable applies.

Recognition A – 60 days:

for applications where the overseas regulator’s approval was granted within the previous 2 years and where there are no complex factors present.

Recognition B – 110 days:

for applications where the regulator’s approval was granted within the previous 10 years and where there are complex factors involved.

The IRP guidance provides am exhaustive list of the complex factors which will mean an application falls under the longer B timetable.

If an application is determined to be ineligible for both A and B, then it must be submitted as a full national application to MHRA in the normal way.

Product Lifecycle

The IRP can be used for post-authorisation procedures including line extensions, variations and renewal applications.

It is recommended that the same overseas regulator is used for IRP applications throughout an individual product lifecycle. However, MAHs may use approvals from more than one regulator during an individual product lifecycle, if this can be justified, for example, on patient benefit grounds.

The relevant published MHRA timetables for national post-authorisation procedures will apply to IRP.

The MHRA may reject a variation application if the evidence is insufficiently robust. Variations impacting 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

Further Details

The guidance also contains details of:

• Forms/document requirements
• The application process
• National requirements
• Fees

If you would like to discuss the authorisation, distribution, sale or marketing of medicines in the UK, please contact our Healthcare Team.

This article was written by Katy Dixon and Rory Trust.