United Kingdom · Medicines and Healthcare products Regulatory Agency · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
-
An authorisation for medicines where full data on efficacy and safety cannot be provided, because the condition is rare or collecting the data is not possible or unethical. It carries specific obligations and is reviewed every year. Rare conditions, or cases where full data collection is not possible or is unethical.
1. Discussion before submission; 2. Application; 3. Grant with specific obligations; 4. Annual reassessment.
Outcome: A UK-wide marketing authorisation with specific obligations, reviewed at least yearly.
Legal basis: Human Medicines Regulations 2012, regulation 60
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP). 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.