United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
110 days
official guidance
Legal time limit
-
Not published
Steps
7
9 requirements
Application fee
£83,580
2025 to 2027 fee schedule
A recognition route for medicines approved by a reference regulator within the last 5 years, or that need more assessment than Recognition A allows. It runs on a 110-day timetable with one clock stop at Day 70. Reference approval within the previous 5 years, or any Recognition B trigger, such as an advanced therapy, a plasma product, an orphan designation request or a conditional approval.
The official review target is 110 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The recognition b, major application (new active substance) is £83,580 for 2025 to 2027 fee schedule.
1. Eligibility form; 2. Submission on a set deadline; 3. Validation (14 days); 4. Assessment to Day 70 (70 days); 5. Applicant answers questions; 6. Assessment to Day 110; 7. Decision.
Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, Japan, Singapore, United States (recognition, recognition, recognition, recognition, recognition, recognition, recognition).
Outcome: A UK-wide marketing authorisation.
Legal basis: Human Medicines Regulations 2012 (regulations 50, 51B, 52B, 53B and 55 applications), International Recognition Procedure
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 144 days end to end with the official step targets, of which up to 60 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. Validation period. | 14 days |
| Longest clock stopofficial guidance. Response time at the Day 70 clock stop. | 60 days |
| Review targetofficial guidance. Calendar days excluding the Day 70 clock stop. Official target, not an actual time. | 110 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Recognition B, major application (new active substance)Application · 2025 to 2027 fee schedule | £83,580 |
| Recognition B, complex applicationApplication · 2025 to 2027 fee schedule | £23,205 |
| Recognition B, standard applicationApplication · 2025 to 2027 fee schedule | £8,503 |
Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine application, Biosimilar application, Well-established use application, Reclassification to pharmacy or general sale, International Recognition Procedure, Recognition A, 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 (36 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.