United Kingdom · Medicines and Healthcare products Regulatory Agency · Over-the-counter
Review target
120 days
official guidance
Legal time limit
-
Not published
Steps
7
4 requirements
Application fee
£40,173
2025 to 2027 fee schedule
Moves a medicine from prescription only (POM) to pharmacy (P), or from pharmacy to general sale (GSL). A major reclassification without an analogous product may need advice from the Commission on Human Medicines. A marketing authorisation holder wants non-prescription supply for an authorised medicine.
The official review target is 120 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The reclassification from prescription only (pom) to pharmacy (p) is £40,173 for 2025 to 2027 fee schedule.
1. Submission and validation; 2. Initial assessment (60 days); 3. Applicant answers questions; 4. Assessment of answers (30 days); 5. Commission on Human Medicines advice; 6. Public consultation (21 days); 7. Decision.
Outcome: A varied authorisation with the new legal supply status.
Legal basis: Human Medicines Regulations 2012 (legal status and reclassification rules; Schedule 11 representations)
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 171 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.
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
| First review cycleofficial guidance. Initial assessment window in calendar days. | 60 days |
| Longest clock stopofficial guidance. Time to answer each request for further information. | 60 days |
| Review targetofficial guidance. Planned approval day when no committee advice is needed. Clock stops for answers are extra. Targets, not actual times. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Reclassification from prescription only (POM) to pharmacy (P)Supplement · 2025 to 2027 fee schedule · 50% less when the agency decides committee advice is not needed. | £40,173 |
| Reclassification from pharmacy (P) to general sale (GSL)Supplement · 2025 to 2027 fee schedule | £10,929 |
| Reclassification based on an analogous product (Type II variation)Supplement · 2025 to 2027 fee schedule | £1,593 |
Other routes in United Kingdom: National assessment for innovative medicines, National assessment for established medicines, Generic medicine application, Well-established use application, 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.