South Korea · Ministry of Food and Drug Safety · Vaccines
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
₩336,000
Notice 2026-31
After the product permit, each lot of a vaccine or other designated biologic needs national lot release before sale. The MFDS reviews the manufacturing and quality records for the lot and tests samples, then issues a lot release certificate. Every lot of a licensed vaccine, plasma-derived product or other biologic the rules designate.
The lot release per lot, pneumococcal conjugate vaccine (electronic filing) is ₩336,000 for Notice 2026-31.
1. Apply for lot release with records and samples; 2. Record review and testing; 3. Lot release certificate.
Outcome: A lot release certificate for that lot.
Legal basis: Pharmaceutical Affairs Act, Article 53; Regulation on Safety of Pharmaceuticals, Articles 64 to 68
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 |
|---|---|
| Lot release per lot, pneumococcal conjugate vaccine (electronic filing)Product · Notice 2026-31 · Fees differ by product; the schedule lists a fee for each biologic. | ₩336,000 |
Other routes in South Korea: Item permit for biological products and vaccines, Biosimilar item permit, Priority review designation (GIFT), Conditional item permit, Orphan drug designation. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.