23-2 · Veterinary medicines & devices

Preparation of veterinary drug wholesaler licence and veterinary quasi-drug import-business notification documents

A veterinary drug wholesaler must obtain a permit (not merely file a report) from the Mayor, County Governor or District Head with jurisdiction over the business location, under Articles 45 and 85 (special provisions for veterinary drugs) of the Pharmaceutical Affairs Act. The facility standard requires a business office and a warehouse, and if only veterinary drugs are handled the warehouse must be at least 33㎡; wholesale operations are managed by a pharmacist, or by the representative if he or she is a pharmacist. The representative and the managing pharmacist need a physician's certificate showing they do not fall under Article 5, subparagraphs 1 and 3 of the Act. To import veterinary quasi-drugs, a separate import business report must be filed with the Director of the Animal and Plant Quarantine Agency under Article 15 of the Rules on Handling of Veterinary Drugs, an import manager must be appointed, and an import permit or import report is required for each item.

HWANG YUNSANG ADMINISTRATIVE OFFICESONGDO · 37.3892° N / 126.6439° E
#Preparation of veterinary drug wholesaler licence and veterinary quasi-drug import-business notification documents#Official check#23-2
01

Procedure

Procedure

Procedure type
  • Permit Difficulty High

    A procedure that allows a business, activity or stay that the law generally restricts, after review; licenses fall into this type. The authority reviews facility standards, location and consultation with other agencies, and a permit can be refused if the standards are not met.

  • Notification Difficulty Low

    You submit the statutory report form and required documents. Once the documents are in order the report is accepted; for some reports the authority checks the contents before accepting it.

We prepare documents for the necessary procedures for veterinary drug wholesaler licensing and veterinary drug quasi-drug importation, product approval, and reporting. The first import business report will be prepared along with the application for the required items.

Scope & fee
Only licensed as a wholesaler of veterinary medicines
We will prepare and submit the veterinary drug wholesaler license application form and attached documents for 1 business location. Medical certificates from the managing pharmacist and representative, as well as facility, warehouse, and equipment data are provided, and import work, product application, pharmacist appointment, facility construction, and on-site visits are not included.
Official fee source ↗
Importation of veterinary quasi-drugs and simultaneous reporting of 1 quasi-drug item subject to reporting
We will prepare the first import business report of veterinary quasi-drugs for 1 company and the item report for 1 type of product. This is the standard for providing 25 pages of basic proof and proof of finished ingredients, testing, safety, and country of manufacture. Technical data development, testing, overseas certification acquisition, translation, notary costs, and on-site visits are not included.
Official fee source ↗
Simultaneous application for 1 quasi-drug item subject to animal quasi-drug import/permission report
We will prepare the first import report of veterinary quasi-drugs for 1 company and item approval for 1 type of product. The standard is to receive 25 pages of basic proof, 30 pages of additional proof of approval review, and proof of completed ingredients, testing, safety, and country of manufacture. Technical data development, testing, overseas certification acquisition, translation, notary costs, and on-site visits are not included.
Official fee source ↗
Import declaration only for 1 item subject to notification of veterinary quasi-drugs by a previously notified importer
We will prepare and submit a product declaration document for 1 type of quasi-drug product for animals from 1 company that has already completed the import business report. This is the standard for providing 30 pages of basic proof and proof of finished ingredients, testing, safety, and country of manufacture. It does not include technical data development, testing, overseas certification acquisition, translation, notary public expenses, on-site visits, and new reports on import businesses.
Official fee source ↗
Only administrative documents for import permission for 1 item subject to approval for veterinary quasi-drugs by a previously reported importer
We will prepare and submit product approval documents for 1 type of quasi-drug product for veterinary use for 1 company that has already completed the import business report. The standard is to receive 30 pages of basic proof, 30 pages of additional proof of approval review, and proof of completed ingredients, testing, safety, and country of manufacture. It does not include technical data development, testing, overseas certification acquisition, translation, notary public expenses, on-site visits, and new reports on import businesses.
Official fee source ↗
  1. 01

    Confirm items handled and the permit scope: Decide whether only veterinary drugs are handled, whether human drugs will also be sold, and whether veterinary quasi-drugs will be imported. Handling human drugs as well changes the warehouse area standard, so fix the business scope first.

  2. 02

    Check the office and warehouse: Under Article 45(2)(ii) of the Act, a warehouse handling only veterinary drugs must be at least 33㎡. Confirm the area and storage layout with the lease, building register use and floor plan, and ask the local government about detailed facility standards in advance.

  3. 03

    Prepare qualification documents for the representative and managing pharmacist: Both obtain a physician's certificate showing they do not fall under Article 5, subparagraphs 1 and 3 of the Act. If the representative is a pharmacist who manages the business directly, no separate managing pharmacist documents are submitted.

  4. 04

    Prepare and submit the wholesaler permit application: Submit the application (Form No. 14) with the certificates, the articles of incorporation for a corporation, and a list of delivery vehicles and equipment to the Mayor, County Governor or District Head of the business location. After the local government checks the site, a permit (Form No. 15) is issued.

  5. 05

    Prepare the import business report and import manager documents: To import quasi-drugs, submit the import business report (Form No. 12-2) with two physician's certificates, the import manager approval or qualification documents, and a facility and equipment statement for import and quality control to the Director of the Animal and Plant Quarantine Agency. Aquatic-only items fall under the National Fishery Products Quality Management Service.

  6. 06

    Prepare item import permit or report documents: Together with the import business report, a permit application or import report must be filed at the same time for at least one item. Oral care, disinfectant and similar quasi-drugs need an import permit, while fiber and rubber products need an import report, so prepare manufacturing and sales certificates (issued within two years) per item.

02

Filing route

Filing route

Wholesaler permit: city, county or district office with jurisdiction over the business location. Quasi-drug import business report: Animal and Plant Quarantine Agency (aquatic-only items: National Fishery Products Quality Management Service)

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

Official check
Actual processing agencyCompetent Korean authority or official service · Competent Korean authority or official service · Competent Korean authority or official service
Statutory and policy authorityMinistry of Agriculture, Food and Rural Affairs · Competent Korean authority or official service
Online routeGovernment24
03

Deadlines & processing notes

Deadlines & processing notes

Check deadlines and next steps against the notice, filing date, and any request for additional documents.Official check
04

Fees & official charges

Fees & official charges

Administrative service fee
  • Only licensed as a wholesaler of veterinary medicines from KRW 300,000
  • Importation of veterinary quasi-drugs and simultaneous reporting of 1 quasi-drug item subject to reporting from KRW 600,000
  • Simultaneous application for 1 quasi-drug item subject to animal quasi-drug import/permission report from KRW 600,000
  • Import declaration only for 1 item subject to notification of veterinary quasi-drugs by a previously notified importer from KRW 400,000
  • Only administrative documents for import permission for 1 item subject to approval for veterinary quasi-drugs by a previously reported importer from KRW 500,000
All administrative service fees exclude 10% VAT.

Included in the basic fee — Initial document review, required-document guidance, basic form preparation, one filing support and responses to up to two supplement requests.

Conditional success fee — For this service, any conditional success fee may be separately agreed within the lawful service scope and stated in a written engagement agreement. No outcome is guaranteed.

Displayed amounts are starting estimates, not statutory or standard rates. The final fee is confirmed after consultation and document review in the engagement agreement. Government fees and actual expenses may change.

Fees & official charges →
05

Basic documents

Basic documents

Basic documents0 / 8

The wholesaler permit is a prior permit, not a report, so buying or selling veterinary drugs before the permit is issued is unlicensed business, and a warehouse under 33㎡ cannot be permitted even after the lease and construction are finished.

Scope of services

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.