Biocidal product approval
A person who intends to manufacture or import a biocidal product for sale or distribution in Korea must obtain approval from the Minister of Environment for the biological product. The effective period for biocidal products is set within 10 years, and those who wish to continue manufacturing or importing such products after the expiration date must obtain product approval again. Those who have received product approval must have manufacturing and storage facilities that meet legal standards to maintain the quality of the product as approved.
| NO | Submission Data | Statutory Statement | Testing | |
|---|---|---|---|---|
| Law | Presidential Decree | |||
| 1 | Applicant's general information | O | X | |
| 2 | Product basics (product name, dosage form, standard consumption, expiration date, etc.) | O | O | O |
| 3 | Physical, chemical or biological properties (including physical hazards, pharmaceutical properties) | O | O | |
| 4 | Classification and labeling | O | X | |
| 5 | Usage and exposure information (including type of a biocidal product) | O | X | |
| 6 | Manufacturing process, etc. | O | X | |
| 7 | Efficacy and effectiveness | O | O | |
| 8 | Health hazards (limited to irritation, hypersensitivity, corrosiveness, and acute toxicity) | O | O | |
| 9 | Environmental hazards | O | O | |
| 10 | Precautions for use and disposal method | O | X | |
| 11 | Domestic and international use and regulatory information | O | X | |
| 12 | Comprehensive data on stability (including risk assessment) | O | X | |
| 13 | Evidence supporting compliance with manufacturing and storage facility standards | O | X | |
Establishing and writing approval data for biocidal products
Establish and write product similarity data for biocidal products
Broker LoAs for approved biocidal substances
Arrange efficacy tests and trials for biocidal products
Writing CSRs
Reviewing biocidal product labeling
Agency services