United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
210 days
official guidance
Legal time limit
210 days
regulation
Steps
7
5 requirements
Application fee
£34,335
2025 to 2027 fee schedule
The MHRA route for medicines that do not meet the innovative criteria, such as known active substances, new forms of established products and hybrid applications. The agency aims for a final decision within 210 days, not counting clock stops. Applications outside the innovative criteria, for example known active substances, line extensions of established products and hybrid applications.
The official review target is 210 days (official guidance). The legal time limit is 210 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The national application fee, complex application (abridged complex) is £34,335 for 2025 to 2027 fee schedule.
1. Submission; 2. Validation (14 days); 3. Technical completeness check; 4. Scientific assessment; 5. Applicant answers questions; 6. Commission on Human Medicines; 7. Decision and public report.
Outcome: A UK-wide marketing authorisation, valid for five years at first. Valid for 5 years.
Legal basis: Human Medicines Regulations 2012, regulations 49 to 55, 58 and Schedule 8
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 197 days end to end with the official step targets, of which up to 183 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Validationofficial guidance. Agency aim for validation. | 14 days |
| Longest clock stopofficial guidance. Up to 6 months for the answer to a request for information. | 183 days |
| Review targetofficial guidance. Official target in calendar days, not an actual review time. Time the applicant takes to answer questions does not count. | 210 days |
| Legal time limitregulation. The law asks the agency to take all reasonable steps to decide within 210 days; the period is suspended while information is awaited. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National application fee, complex application (abridged complex)Application · 2025 to 2027 fee schedule · Small companies can pay 50% of a complex application fee at submission and the rest within 30 days of the decision. | £34,335 |
| National application fee, standard application (abridged standard)Application · 2025 to 2027 fee schedule | £12,589 |
Other routes in United Kingdom: National assessment for innovative medicines, Generic medicine application, Well-established use application, Reclassification to pharmacy or general sale, International Recognition Procedure, Recognition A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP), Rolling review, MHRA-NICE aligned pathway. See all routes on the United Kingdom page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (26 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.