Quasi-Drug Manufacturing Business Report and Product Report (Oral Fresheners, etc.)

Procedure

01
Confirm quasi-drug status: Check from the intended use, efficacy claims and formulation whether the product is a quasi-drug and which category, such as oral fresheners, it belongs to. For products on the border with cosmetics or sanitary products, review the formulation and labeling text together.
02
Distinguish product report from product approval: Products listed in compendia, conforming to the standard manufacturing criteria, or covered by notified standards and test methods are reported to the Regional Office of Food and Drug Safety. If the ingredients, strength or efficacy fall outside these, apply to the Ministry of Food and Drug Safety for product approval and submit safety and efficacy data.
03
Secure facilities and a manufacturing manager: Equip a work area, testing room, storage area and the facilities and instruments needed for manufacturing and quality control. If manufacturing or testing is outsourced to another manufacturer, the related facilities may be omitted, and an oral freshener manufacturing site must have a pharmacist or herbal pharmacist as manufacturing manager.
04
Submit the business report and product documents: Attach the representative's medical certificate and the manufacturing manager's qualification documents to the quasi-drug manufacturing business report, file it with the competent Regional Office of Food and Drug Safety through the Drug Safety Portal (nedrug), and submit a product report or product approval application for at least one product at the same time.
05
Respond to supplementation requests: If the quantities of raw materials, standards and test methods, or efficacy wording do not match the report criteria or supporting data, a supplementation request is issued. Reorganize comparison tables, test results and formulation evidence and resubmit within the set deadline.
06
Post-report changes and labeling: Report changes in the manufacturing site location, manufacturing manager or reported product particulars. Before shipment, check that container and package labeling and advertising wording do not exceed the reported efficacy.

Filing route

Regional Office of Food and Drug Safety with jurisdiction over the manufacturing site (Drug Safety Portal e-filing); product approvals requiring data review go to the Ministry of Food and Drug Safety

Confirm the current filing office, jurisdiction, and online availability on the official website.

Official check

Actual processing agencyCompetent Korean authority or official service

Statutory and policy authorityMinistry of Food and Drug Safety

Online routeCompetent Korean authority or official service

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check

Basic documents

Basic documents0 / 8

Quasi-drug manufacturing business report (Form No. 2 of the Rules on the Safety of Pharmaceuticals, etc.)Report on manufacture-for-sale or import of pharmaceuticals, etc. (Form No. 6 of the same Rules) or product approval application (Form No. 4 of the same Rules)Representative's medical certificate (confirming no disqualification for mental illness or narcotics addiction)Manufacturing manager qualification documents (pharmacist or herbal pharmacist license, etc.)Floor plan of the manufacturing site and list of facilities and instruments (work area, testing room, storage area)Raw materials and their quantities, and manufacturing methodStandards and test methods, and evidence that the product is subject to a report (comparison table against standard manufacturing criteria, etc.)Container and package labeling draft, and outsourced manufacturing or testing contract (if outsourcing)

An oral freshener manufacturing business report is accepted only if a pharmacist or herbal pharmacist manufacturing manager is in place, so confirm the hiring of the manufacturing manager before starting facility construction or ordering raw materials.

Scope of services

Hwang Yunsang Administrative Agent Office prepares and translates documents for administrative agencies, submits them on your behalf, and guides you through permit, application, and notification procedures. Services that require the principal’s personal appearance, principal’s application, or electronic signature may be limited in delegation.