South Korea · Ministry of Food and Drug Safety · Over-the-counter
Review target
10 working days
regulation
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
-
Products listed in the Korean Pharmacopoeia or a recognized compendium, or made to a published standard manufacturing formula, can be notified to a regional MFDS office instead of getting a full permit. Many over-the-counter products use this route. Korea has no separate OTC approval route: the MFDS classifies each product as prescription or over-the-counter during the permit or notification. Products that match a pharmacopoeia monograph, a published standard manufacturing formula or test standard, or another item the agency lists for notification. Biologics and radiopharmaceuticals are excluded.
The official review target is 10 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. File the item notification; 2. Review by the regional office (10 days); 3. Notification accepted.
Outcome: An accepted notification, valid for 5 years and renewable. Valid for 5 years.
Legal basis: Pharmaceutical Affairs Act, Articles 2(9) and 31(2); Regulation on Safety of Pharmaceuticals, Article 5; Regulation on Classification of Drugs
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 10 days end to end with the official step targets. 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
| Review targetregulation. Official processing periods, not actual review times. Periods over 5 days count working days (Saturdays and public holidays are not counted). Time the applicant spends answering requests is outside the period. | 10 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in South Korea: New drug item permit, Item permit for data-submission drugs (including incrementally modified drugs), Generic drug item permit (bioequivalence), Priority review designation (GIFT), Conditional item permit, Orphan drug designation, Drug-device combination products. See all routes on the South Korea 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 (14 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.