Importing Pet Wipes for Dogs: Veterinary Quasi-Drug Classification, Import Business Report and Korean Labeling

Procedure

1. 1. Check whether the product is a veterinary quasi-drug based on its use and ingredients

   Attached Table 1 of the Regulation on the Scope and Designation of Veterinary Quasi-Drugs lists animal ear cleansers, eye cleansers and eye-area cleansers, and Attached Table 2 lists animal disinfecting tissues as veterinary quasi-drugs (Article 2 of the same Regulation). The wet-wipe form alone does not decide the classification, so the use stated on the package (wiping around the eyes, disinfection, etc.), the ingredients and their amounts, and the directions for use are checked against the manufacturer's data. If the product is a general cleaning product outside the notice, whether other laws such as the rules on household chemical products apply must be checked separately.

2. 2. Request a classification review when the status is unclear

   If the status is unclear, you may request the Commissioner of the Animal and Plant Quarantine Agency to review whether the product is a veterinary quasi-drug, submitting materials on its purpose of use, raw materials and amounts, efficacy and dosage, and pharmacological action and specifications (Article 3(1) of the same Regulation). The Commissioner reviews the status and whether the item can be designated and notifies the result within 7 days (Article 3(2)). These 7 days are the notification period for the classification review only, not the processing period for the import business report or item procedures.

3. 3. Appoint an import manager and file the import business report

   The qualifications of an import manager follow the rules for manufacturing managers, so items under item (a) such as eye-area cleansers require a pharmacist or herbal pharmacist, while items under item (b) such as disinfecting tissues require a physician, veterinarian or pharmacist, a graduate of a science or engineering department of a 4-year university, or a person who has worked in manufacturing veterinary quasi-drugs for the period set by educational background (Articles 12 and 16-2(1) of the Enforcement Rule on the Handling of Veterinary Medicinal Products). The import business report is filed with the Commissioner of the Animal and Plant Quarantine Agency using Form No. 12-2, attaching the representative's medical certificates, the import manager approval or documents confirming qualifications, and a list of facilities and equipment for import and quality control (Article 15(1) of the same Rule). At the time of the report, an application for import item permission or an import item report for at least 1 item must be filed together (Article 15(3)).

4. 4. Obtain import item permission or file an import item report for each item

   Items under item (a) require an application for import item permission on Form No. 5, and items under item (b) require an import item report on Form No. 5-3 (Articles 5 and 16 of the same Rule). In both cases, documents on the product name, raw material amounts, efficacy, dosage, package unit, storage, shelf life, and test standards and methods, together with safety and efficacy review materials, are prepared, and a manufacturing certificate from the government of the producing country and a sales certificate from the government of the country where the item is permitted or registered are each submitted. Both certificates must have been issued within 2 years before the application date (Article 16(1)1(b) of the same Rule).

5. 5. Prepare Korean labeling for individual packs and outer packages

   An importer must state on the container or package directly holding the quasi-drug its name, the importer's trade name and address, volume, weight or count, the batch number and expiry date, the ingredient names stated in the item permit or report certificate, and the words 'quasi-drug' (Article 65(1) of the Pharmaceutical Affairs Act). For veterinary products, the words 'veterinary quasi-drug' and the efficacy are added, written in Korean or Korean mixed with Chinese characters (Articles 42 and 43(2) of the Enforcement Rule on the Handling of Veterinary Medicinal Products). If the labeling on the direct package is hidden by the outer package, the same items must also be written on the outer package (Article 65-2 of the Pharmaceutical Affairs Act); this is an additional labeling duty, so it is not a basis for replacing labeling on individual packs with a sticker on the outer package.

Required documents

• Veterinary medicinal product and veterinary quasi-drug import business report (Form No. 12-2 of the Enforcement Rule on the Handling of Veterinary Medicinal Products)
• Application for veterinary quasi-drug import item permission (Form No. 5 of the same Rule) or import item report (Form No. 5-3 of the same Rule)
• Physician's medical certificates proving that the representative does not fall under Article 5 subparagraphs 1 and 3 of the Pharmaceutical Affairs Act
• Import manager approval (Form No. 10 of the same Rule) or documents confirming the import manager's qualifications (if approval is required, an approval application on Form No. 9 and documents proving qualifications)
• List of facilities and equipment needed for import and quality control
• Documents for each item on product name, raw material amounts, properties, manufacturing method, efficacy, dosage, package unit, storage, shelf life, precautions, and test standards and methods, together with safety and efficacy review materials
• Manufacturing certificate issued by the government of the producing country and sales certificate issued by the government of the country of permission or registration (each issued within 2 years before the application date), with translations of foreign-language documents
• Label designs for individual packs and outer packages (including Korean label text)
• Materials for a classification review request (purpose of use, raw materials and amounts, efficacy and dosage, pharmacological action and specifications, if the status is unclear)

Fees

Government fees are 30,000 won for the import business report (as stated on the report form; 5,000 won for a change report), 10,000 won per item for import item permission, 10,000 won for an import item report (as stated on the report form), and 1,000 won for import manager approval; testing and analysis costs and the cost of obtaining foreign certificates are separate. Our office fee starts from the amount shown above and may vary depending on the number of items, whether a classification review request is needed, whether item permission or an item report applies, and the scope of label text review; we will give you an exact quote after reviewing your documents.

See fees and official charges for this service →

Legal basis and review date

• Pharmaceutical Affairs Act Article 2
• Pharmaceutical Affairs Act Article 36
• Pharmaceutical Affairs Act Article 37
• Pharmaceutical Affairs Act Article 42
• Pharmaceutical Affairs Act Article 65
• Pharmaceutical Affairs Act Article 65-2
• Pharmaceutical Affairs Act Article 85
• Pharmaceutical Affairs Act Article 93
• Pharmaceutical Affairs Act Article 96
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 2
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 5
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 12
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 15
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 16
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 16-2
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 42
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 43
• Enforcement Rule on the Handling of Veterinary Medicinal Products Article 56 and Attached Table 4
• Enforcement Rule on the Handling of Veterinary Medicinal Products Forms No. 5, 5-3, 9, 10 and 12-2
• Regulation on the Scope and Designation of Veterinary Quasi-Drugs Articles 2 and 3, Attached Tables 1 and 2

Checked against the statutes on 2026-10-28

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

• Importing wipes that are veterinary quasi-drugs without an import business report or item permission or report is subject to penalties under Article 93(1)5 of the Pharmaceutical Affairs Act, and selling them without the statutory labeling may be subject to penalties under Article 96 subparagraph 4 of the same Act, so the classification and item procedures must be completed before sale.
• An amendment to the Enforcement Rule on the Handling of Veterinary Medicinal Products (Ordinance of the Ministry of Agriculture, Food and Rural Affairs No. 783) is scheduled to take effect on January 1, 2027 and may change some document requirements for item permission, so check the rules in force at the time of application.

Frequently asked questions