Veterinary Quasi-Drug Manufacturing Business Report — Product Approval vs Product Report and Manufacturing Manager Qualifications

Procedure

1. 1. Confirm that the product is a veterinary quasi-drug and identify the competent agency

   The Rules on the Handling of Veterinary Drugs, etc. define veterinary quasi-drugs as items with a mild effect on animals, such as pet preparations including oral fresheners, cleansers and deodorants, animal disinfectants, pest control agents and nutritional vitamin preparations (item ga), and textile and rubber products used to treat or prevent animal diseases (item na), with specific products designated by public notice. Products for livestock, beekeeping, sericulture and pets (excluding ornamental fish) and products for both agricultural and fishery use fall under the Commissioner of the Animal and Plant Quarantine Agency, while products used only for aquatic animals, including ornamental fish, fall under the Director of the National Fishery Products Quality Management Service.

2. 2. Prepare the manufacturing facility and quality control system

   A quasi-drug manufacturing site needs a work area for manufacturing, a testing laboratory to control the quality of raw materials and products, a storage area for raw materials and products, and the facilities and equipment needed for manufacturing and quality control. A business that has filed a manufacturing report must also have testing facilities for manufacturing control and in-house testing and quality control standards for each product. If the process discharges hazardous substances, the facility statement must include the prevention facilities.

3. 3. Check manufacturing manager qualifications and apply for approval

   A manufacturer of item ga products (pet preparations, disinfectants, pest control agents, vitamin preparations and the like) must appoint a pharmacist or herbal pharmacist as manufacturing manager for each site. For item na products (textile and rubber products), the manager may be a physician, veterinarian, pharmacist, a graduate of a four-year science or engineering program, or a person with the required manufacturing experience, approved through an application on Form No. 9 (processing time 4 days). If two or more managers are appointed, their duties and responsibilities must be divided.

4. 4. File the manufacturing business report together with product documents

   Attach the representative's medical certificate, a copy of the manufacturing manager approval (if approval is required), facility structure and equipment documents and the facility statement to the veterinary quasi-drug manufacturing business report on Form No. 4-2, and submit it together with the product approval application or product report. The processing time for the report is 10 days and the fee is 10,000 won. Once the report is accepted, a manufacturing business report certificate is issued.

5. 5. Product approval or product report and later changes

   Item ga products are filed for product approval on Form No. 5, and the processing time is 10 days for products that do not require a safety and efficacy review. Item na products are filed as product reports on Form No. 5-3, and products that the Minister of Agriculture, Food and Rural Affairs has announced as having no safety or efficacy issues are reported to the President of the Korea Animal Health Products Association. If reported details of the manufacturing business change, a change report must be filed on Form No. 19 within 30 days of the change.

Required documents

• Veterinary quasi-drug manufacturing business report (Rules on the Handling of Veterinary Drugs, etc., Form No. 4-2)
• Veterinary quasi-drug product approval application (same Rules, Form No. 5) or product report (Form No. 5-3)
• Physician's medical certificate showing that the representative does not fall under Article 5, Subparagraphs 1 and 3 of the Pharmaceutical Affairs Act
• Copy of the manufacturing manager approval (where an approved manager is appointed, such as for item na products), and the pharmacist license of a pharmacist manager (if consent to administrative information sharing is not given)
• Documents showing the structure and equipment of the manufacturing facility and the facility statement (including hazardous substance prevention facilities)
• Documents for each product on product name, quantity of raw materials, properties, manufacturing method, efficacy, dosage and administration, package unit, storage method, shelf life, precautions, and test standards and methods
• Safety and efficacy review data (where applicable) and documents on the manufacturing process
• Corporate registration certificate (for corporations, checked by the official in charge)

Fees

Typically in the range of several hundred thousand won in the industry. We provide a quote after consultation based on the number of products, whether product approval or product report applies, and whether safety and efficacy data are needed. Government fees (10,000 won for the manufacturing report, 10,000 won per product, etc.) are separate.

See fees and official charges for this service →

Legal basis and review date

• Pharmaceutical Affairs Act, Article 31
• Pharmaceutical Affairs Act, Article 36
• Pharmaceutical Affairs Act, Article 85
• Decree on Facility Standards for Manufacturers and Importers of Pharmaceuticals, Article 3
• Rules on the Handling of Veterinary Drugs, etc., Article 2
• Rules on the Handling of Veterinary Drugs, etc., Article 2-2
• Rules on the Handling of Veterinary Drugs, etc., Article 4
• Rules on the Handling of Veterinary Drugs, etc., Article 5
• Rules on the Handling of Veterinary Drugs, etc., Article 12
• Rules on the Handling of Veterinary Drugs, etc., Article 13-2
• Rules on the Handling of Veterinary Drugs, etc., Article 24
• Rules on the Handling of Veterinary Drugs, etc., Article 56 and Annex 4
• Rules on the Handling of Veterinary Drugs, etc., Forms No. 4-2, 5, 5-3 and 9

Checked against the statutes on 2026-10-16

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• The manufacturing business report must be filed together with a product approval application or product report for at least one product, so if product data (raw material quantities, manufacturing method, test standards) are not ready, the manufacturing report cannot proceed either.
• If reported details of the manufacturing business change, a change report must be filed within 30 days of the change, and changes to product approval or report details are applied for separately on Form No. 20.

Frequently asked questions