United Kingdom · Medicines and Healthcare products Regulatory Agency · Generics
Review target
210 days
official guidance
Legal time limit
210 days
regulation
Steps
5
5 requirements
Application fee
£12,589
2025 to 2027 fee schedule
A generic can leave out its own preclinical and clinical trial results when it is a generic of a UK reference medicine authorised for at least eight years. It cannot be sold until ten years after the reference medicine was first authorised. Same active substance and pharmaceutical form as a UK reference medicine, with bioequivalence shown.
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, standard application (abridged standard), as typically charged for a generic is £12,589 for 2025 to 2027 fee schedule.
1. Submission; 2. Validation (14 days); 3. Assessment; 4. Applicant answers questions; 5. Decision.
Outcome: A UK-wide marketing authorisation, valid for five years at first. Valid for 5 years.
Legal basis: Human Medicines Regulations 2012, regulation 51B
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.
From the official approvals data of this market, all products of this pathway type and segment
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 |
| Legal time limitregulation. Period suspended while requested information is awaited. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National application fee, standard application (abridged standard), as typically charged for a genericApplication · 2025 to 2027 fee schedule | £12,589 |
Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, 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. 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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.