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The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK.

Under this process, the MHRA will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application.

Eligibility

The 150-day assessment is available for all high-quality new MAAs submitted to MHRA.

How to apply

You can apply for a marketing authorisation (MA) for new active substances and biosimilar products or existing active substances. There are different application processes but all applications should be submitted through the MHRA Submission Portal.

You can find out more in our guidance about the MHRA submission portal.

You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.

New active substances and biosimilar products applications

We recommend you email presubmission@mhra.gov.uk before you intend to submit an application. You should tell us the intended date of submission of the dossier and whether the MAA is to be submitted to UK, Great Britain (England, Scotland and Wales) only, or Northern Ireland only.

If the application includes Northern Ireland, then it must comply with EU requirements.

Before you submit your application, you should read our guidance on Procedures for UK Paediatric Investigation Plans (PIPs).

A UK PIP compliance check (CC) should be completed 60 days before your intended submission.For medicinal products presented or used with a device component, you should read our guidance on regulating medical devices.

MHRA will arrange a pre-submission meeting with you.

Access Consortium work-sharing procedures: If you are considering a National Application for either a new active substance, a biosimilar product, or a new indication application, then the MHRA invites you to consider submission via an Access Consortium work-sharing procedure. These procedures allow simultaneous submission to the UK, Australia, Canada, Singapore and/or Switzerland. Potential advantages to companies include:

• Simultaneous submission for access to multiple markets.
• Streamlined process: Internationally coordinated review to reduce duplication/burden. Joint, consolidated lists of questions, capturing the assessment of all agencies.
• Predictability: Work-sharing and peer-review between agencies, with pre-determined joint international milestones.
• Competitive timetables: Standard procedure of 180 days (excluding stop-clocks).
• Flexibility: Module 1 will be different between jurisdictions, while minor differences in Module 2-5 may also be accepted. Separate sovereign decisions at end of procedure
• Opportunity to make a contribution to innovation in the area of regulation.

For further information, or to express an interest in an Access Consortium submission, please contact access-mhra@mhra.gov.uk .

Pre-submission meeting

The pre-submission meeting applies to new active substances and biosimilar applications.

The pre-submission meeting should be requested at least 90 days before the intended submission date. The meeting request should be made via email at presubmission@mhra.gov.uk

At the meeting applicants may wish to provide a short summary of the dossier to share their intentions and to verify the new active substance status. They may want to raise any specific issues such as requests for:

• consideration for orphan MA
• conditional MA
• MA under exceptional circumstance

The meeting will also offer opportunity to discuss the arrangements for UK Compliance Check onPIPs. The pre-submission meeting may offer the opportunity to enhance joint discussion with the National Institute for Health and Care Excellence (NICE) Health Technology Assessment (HTA) evaluation process.

TheMHRAwill operate a fixed submission date system to facilitate consultation with the Commission on Human Medicines (CHM) and will publish a set of dates to facilitate planning the submissions to coordinate with appropriatemeeting dates ofCHM.

Existing Active Substances applications

If you are applying for MA in Great Britain (England, Scotland and Wales) you should read our guidance on choosing acceptable reference medicinal products for generic applications and/or bioequivalence (BE) studies.

You should also refer to any MHRA product-specific BE guidance for applications made only to Great Britain.

Validation

The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

New active substances and biosimilar products

You should submit a valid, full application for evaluation. The accompanying cover letter should detail the intention to seek orphan status or MA under exceptional circumstances as applicable.

A valid application/dossier should include common technical modules (CTD modules 2-5) and a UK specific CTD module 1, consisting of an appropriate Risk Management Plan (RMP), UK PIP CC and/or compliance with UK Orphan Medicines requirements, when applicable.

The SmPC/PIL may be submitted as Word documents in the working documents folder. There is an option to put the UK specific SmPC PIL/Labelling text/mock-ups in the UK specific folder which is available within the eCTD structure.

Applications that refer to an ASMF should ensure that the file (including the restricted part) has already been submitted to MHRA and a suitable letter of access authorising MHRA

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