UK MHRA Guidance: Register to make submissions to the MHRA and the International Recognition Procedure

Efficient regulatory submissions depend not only on preparing high-quality dossiers but also on using the correct submission systems and selecting the appropriate regulatory pathway. For companies seeking to submit medicines applications, clinical trial documentation, or safety reports in the UK, understanding the Medicines and Healthcare products Regulatory Agency (MHRA) submission infrastructure is essential.

The MHRA provides guidance covering two important areas: Register to Make Submissions to the MHRA, which explains how organizations can gain access to regulatory and vigilance submission systems, and the International Recognition Procedure (IRP), which enables the MHRA to consider assessments and approvals from specified trusted Reference Regulators when evaluating eligible UK marketing authorisation applications.

Guidance: Register to Make Submissions to the MHRA

This guidance explains how pharmaceutical companies, clinical trial sponsors, and other organizations can access MHRA submission portals and vigilance systems. The guidance provides information on gaining access to MHRA Submissions and registering to use pharmacovigilance systems, including the MHRA Gateway and ICSR Submissions.

Gaining Access to MHRA Submissions

MHRA Submissions supports regulatory activities involving UK medicines licences and clinical trials. Clinical trial sponsors can use the system for activities including initial applications, modifications, end-of-trial notifications, and Development Safety Update Reports (DSURs). Organizations must establish appropriate user access, beginning with an initial company administrator. The administrator manages organizational access and can add additional company administrators, internal users, and external consultants.

Having appropriate administrator arrangements helps organizations maintain effective control of regulatory submission activities and ensures continuity of access to MHRA systems.

Company Administrators and Users

Company administrators have broader permissions within the MHRA submission system, including managing user access and viewing relevant submission information. Standard users can make submissions for organizations to which they have been assigned but do not have the same user-management permissions.

Organizations with multiple legal entities should ensure that the correct entities and relevant MHRA company information are appropriately established within the system to support regulatory submissions.

Registering for MHRA Vigilance Systems

Pharmaceutical companies submitting Individual Case Safety Reports (ICSRs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) can use the MHRA Gateway or ICSR Submissions.

Organizations using the MHRA Gateway must first complete the necessary registration process. Companies that do not have the technical capability to use the Gateway can use the ICSR Submissions system as an alternative route for submitting applicable safety reports.

Establishing appropriate access to these systems is important for maintaining timely pharmacovigilance reporting and meeting applicable UK regulatory requirements.

Guidance: International Recognition Procedure (IRP)

The International Recognition Procedure (IRP) provides a regulatory pathway for eligible medicines that have already received authorisation from one of the MHRA's specified Reference Regulators.

The IRP allows the MHRA to consider the expertise and regulatory decisions of trusted international authorities while conducting its assessment of a UK marketing authorisation application. However, the MHRA retains responsibility for the final regulatory decision and may approve or refuse an application based on its assessment of the submitted evidence.

Scope of the International Recognition Procedure

The IRP can support different types of marketing authorisation applications, including:

• Chemical and biological new active substances

• Known active substances

• Generic applications

• Hybrid applications

• Biosimilar applications

• New fixed-combination products

The procedure may also be available for eligible post-authorisation activities, including variations and renewals.

The Reference Regulator's authorisation should be based on an appropriate regulatory assessment. Applicants are responsible for providing the necessary supporting documentation from the Reference Regulator to enable the MHRA to conduct its assessment.

Initial IRP Marketing Authorisation Applications

For an initial IRP marketing authorisation application, the product submitted to the MHRA should correspond to the product authorised by the Reference Regulator, including relevant aspects of its composition, pharmaceutical form, and therapeutic use.

Applicants must provide the required evidence of Reference Regulator approval together with the relevant assessment documentation. The MHRA then conducts its assessment while retaining independent authority over the final UK marketing authorisation decision.

Validation

Applications submitted through the IRP must meet the applicable validation requirements before regulatory assessment can proceed.

Applicants should ensure that all required documents and Reference Regulator information are included in the submission. Complete and accurate documentation is important to avoid validation issues and potential delays in the regulatory review process.

Post-Authorisation IRP Applications

The IRP is not limited to initial marketing authorisation applications. Eligible post-authorisation procedures, including variations and renewals, may also use the recognition pathway where applicable.

Applicants should confirm that their proposed regulatory procedure meets the relevant IRP eligibility requirements and provide the necessary Reference Regulator documentation to support the MHRA assessment.

How to Apply

Applicants intending to use the IRP should follow the applicable MHRA submission procedures and provide the required application documentation through the appropriate submission route.

The submission should include relevant Reference Regulator documents and information necessary for the MHRA to verify eligibility and conduct its assessment.

National Requirements and Fees

Using the International Recognition Procedure does not remove the requirement to comply with applicable UK national regulatory requirements. Applicants remain responsible for providing UK-specific information where required and ensuring that their applications meet national requirements for marketing authorisation. Applicable regulatory fees must also be paid according to the relevant MHRA fee structure.

Reference Regulator Documentation

Reference Regulator documentation is an important component of the IRP. Applicants should provide the required assessment reports and regulatory documents associated with the Reference Regulator's decision.

Providing complete documentation enables the MHRA to understand the basis of the previous regulatory assessment and determine whether the application can appropriately proceed through the recognition pathway.

References

• Register to Make Submissions to the MHRA

• International Recognition Procedure (IRP)