United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
210 days
official guidance
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
£34,335
2025 to 2027 fee schedule
An application that relies on published scientific literature instead of the applicant's own trials. The active substances must have been in well-established medicinal use for at least 10 years, with recognised efficacy and acceptable safety. Active substances with at least 10 years of well-established medicinal use in the UK or the EU.
The official review target is 210 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The national application fee, complex application (literature-based applications fall in the complex group) is £34,335 for 2025 to 2027 fee schedule.
1. Submission; 2. Validation (14 days); 3. Assessment; 4. Decision.
Outcome: A UK-wide marketing authorisation, valid for five years at first. Valid for 5 years.
Legal basis: Human Medicines Regulations 2012, regulation 54
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 14 days end to end with the official step targets. 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 |
| 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 |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National application fee, complex application (literature-based applications fall in the complex group)Application · 2025 to 2027 fee schedule | £34,335 |
Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine 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. See all routes on the or explore them in the .
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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.