Singapore · Health Sciences Authority · Over-the-counter
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
5
2 requirements
Application fee
-
A registered medicine can move to a lower access class, for example from prescription-only to pharmacy-only, or from pharmacy-only to general sale. The registrant files a major variation (MAV-2) on the abridged route. There are no screening or evaluation fees. Targets are 50 working days for screening and 180 working days for evaluation. A registered medicine with long, documented safe use that fits the criteria of a less controlled access class.
The official review target is 180 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Reclassification application; 2. Screening (50 days); 3. Evaluation (180 days); 4. Questions (clock stopped); 5. Decision on the new access class.
Outcome: Updated access class on the existing registration.
Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016
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 230 days end to end with the official step targets. 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
| Validationperformance goal. Official target, not actual time. | 50 working days |
| Review targetperformance goal. Official target, without the applicant's answer time. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Singapore: Non-prescription medicine application (abridged). See all routes on the Singapore 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.