UK MHRA guidance: National Assessment Procedure for Medicines
The National Assessment Procedure for Medicines provides a framework for UK-wide marketing authorisation applications assessed through the national procedure. It covers applications for innovative and established medicines, including submission requirements, assessment stages, timelines, requests for information, Commission on Human Medicines involvement, and regulatory decisions.
Introduction
The national assessment procedure applies to UK-wide marketing authorisation applications for innovative and established medicines. Different requirements and timelines apply to each category.
Innovative medicines may receive a positive decision within 150 clock-on days when issues are resolved following one round of questions, while outstanding issues may result in a final decision within 210 clock-on days. Established medicines applications have a final decision within 210 days, excluding regulatory clock-stops.
Variations to existing marketing authorisations, including Type II variations for new therapeutic indications, are outside the scope of this procedure.
Before You Apply
Applicants can request scientific advice during medicine development. UK paediatric requirements may apply, and where a Paediatric Investigation Plan compliance check is required, the request should be submitted at least 60 days before the planned marketing authorisation application.
A proposed product name must be included in the application. Applications should be submitted through the MHRA Submission Portal, with applicable national fees paid.
The Windsor Framework
The Windsor Framework allows medicinal products formerly within the scope of the EU centralised procedure to be licensed UK-wide under UK law.
Medicinal products are assigned to Category 1 or Category 2. Applicants must assign the proposed category when submitting the application, with the final agreed category included in the grant letter.
Innovative Medicines Applications
Innovative medicines applications include new active substances, biological products, advanced therapy medicinal products, vaccines, biosimilars, new combinations of existing active substances and orphan medicinal products.
The category also includes conditional marketing authorisations, marketing authorisations under exceptional circumstances and certain line extensions. Certain Project Orbis applications also follow this procedure, while Access Consortium New Active Substance Work Sharing Initiative applications have a different timetable.
Before Submission
Applicants must notify the MHRA of their intended submission date. A pre-submission meeting is strongly recommended for national innovative medicine applications and may be required in certain circumstances.
The meeting can help identify procedural or logistical issues and ensure appropriate assessment expertise and resources are available. Paediatric requirements should also be considered where applicable.
Submission
A complete electronic Common Technical Document must be submitted, including Modules 2 to 5 and a UK-specific Module 1.
The cover letter should identify relevant information such as orphan designation, conditional marketing authorisation or marketing authorisation under exceptional circumstances. Following validation, the assessment clock starts on the applicable procedure start date.
Initial Assessment Phase
The initial assessment takes place up to Day 90 and may include consultation with the Commission on Human Medicines or its expert advisory groups.
By Day 90, the applicant receives a consolidated request for information covering the dossier. This may include major objections that could prevent the marketing authorisation or orphan designation if unresolved.
Responses Assessment Phase
Applicants must respond to the first request for information within 6 months, although earlier submission is encouraged. Responses are submitted as an eCTD sequence.
Assessment of the response is completed by Day 150. Minor outstanding issues may result in a second request for information, while unresolved major objections may result in a Commission on Human Medicines letter.
Final Assessment Phase
A complete response to a second request for information must normally be submitted within 3 months. Once received, the assessment clock restarts.
If outstanding issues are resolved, final compliance checks are completed and the application may be granted by Day 210. Where necessary, a third request for information may be issued to resolve final minor issues.
Commission on Human Medicines Letter and Representations
A Commission on Human Medicines letter may be issued where the Committee has a provisional opinion that it may be unable to advise on granting the authorisation or orphan designation.
Applicants have an opportunity to make written or oral representations. They must confirm the type of representation within 28 days, with representations normally made within a further 6 months unless an extension is agreed.
Decision for Innovative Medicines
The decision is communicated through a grant letter or refusal letter. The grant letter specifies applicable conditions and the expiry date of the marketing authorisation.
A UK public assessment report is published for new marketing authorisations, with commercially confidential information and protected personal data removed and a lay summary included.
For new active substances, a press release is published within one week and the public assessment report within 30 days. For other marketing authorisation types, the report is published within 60 days.
Access Consortium Work-Sharing Procedures
Applicants considering national applications for new active substances or biosimilars are encouraged to consider an Access Consortium work-sharing procedure.
These procedures allow simultaneous submission to participating countries and internationally coordinated review. The standard procedure is 180 days excluding clock-stops, with the MHRA aiming to make a national decision within 210 days of the procedure start.
Established Medicines Applications
Established medicines applications are those that do not meet the criteria for innovative medicines.
Checklists are available to support right-first-time submissions, including bioequivalence studies, biowaivers and product information. UK paediatric requirements may also apply.
Submission for Established Medicines
A complete eCTD must be submitted, including Modules 2 to 5 and a UK-specific Module 1.
Where an Active Substance Master File is referenced, it should already have been submitted with the appropriate letter of authorisation. The MHRA aims to validate applications within 14 days.
Assessment of Established Medicines
Assessment initially includes a technical completeness check. Technically complete applications undergo scientific assessment, with a final decision aimed for within 210 days excluding clock-stops.
Where deficiencies are identified, the applicant may receive a request for information or a Commission on Human Medicines letter.
Request for Further Information
Where deficiencies can be resolved, a consolidated request for information is issued and the clock is stopped.
Applicants normally receive one request covering the relevant dossier sections and may also receive assessment reports and annotated product information documents.
Response Assessment
Applicants have a maximum of 6 months to submit a complete response, although earlier submission is encouraged.
The response must be submitted as an eCTD sequence. Once received, the clock restarts. If the issues are resolved, final compliance checks are completed and the application may be granted by Day 210.
Where quality, safety or efficacy issues remain unresolved, the application may be referred to the Commission on Human Medicines for advice on refusal.
Consulting the Commission on Human Medicines
Major objections are deficiencies that, if unresolved, would prevent a marketing authorisation.
Where major objections are identified, the Commission on Human Medicines may be consulted. Applicants may receive a letter explaining the provisional position and are given an opportunity to make written or oral representations before final advice is provided.
Decision for Established Medicines
Applicants receive either a grant letter or refusal letter. The grant letter specifies any conditions and the expiry date of the marketing authorisation.
A UK public assessment report is published for new marketing authorisations, with the completed report published within 60 days of the grant.
A refusal letter includes the grounds for refusal and information on requesting a review of the decision.
The guidance was last updated on 16 September 2026. The update included changes to pre-submission requirements for innovative medicines applications, including notification expectations, circumstances where a pre-submission meeting may be required and information-sharing arrangements for the MHRA-NICE aligned pathway.
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