Cosmetics Responsible Distributor Change Registration in Korea — 30-Day Deadline, Documents, Manager Replacement

A cosmetics responsible distributor (화장품책임판매업) must file a change registration with the Regional Office of Food and Drug Safety within 30 days from the date the change occurred whenever its representative, trade name, business address, responsible sales manager or distribution type changes. Under the Cosmetics Act, this business is subject to registration, and changes to important registered items must be registered in the same way.

For the initial process, see our guide to responsible distributor registration; this article covers changes after registration.

Changes that require change registration

The Enforcement Rule of the Cosmetics Act lists five cases in which a responsible distributor must file a change registration. The attachments and processing period differ by case.

Change	Attachments besides the application and certificate	Processing period
Change of the business operator (for a corporation, its representative)	Proof of transfer, if the business was transferred	10 days
Change of trade name (for a corporation, its corporate name)	No additional document specified	10 days
Change of business address	No additional document specified	10 days
Change of responsible sales manager	Documents proving the new manager's qualifications	7 days
Change of distribution type	When moving from, or adding to, the import-agency type: the quality control and post-market safety standards and the manager's qualification documents	10 days

The regional office checks the corporate register itself through shared administrative information, and in the case of inheritance it also checks the family relation certificate. A transferee or heir succeeds to the previous operator's status, but a change of operator is itself a change registration item, so the filing is still required.

A person who newly becomes the operator must not fall under the disqualifications of the Cosmetics Act, such as being under adult guardianship, having been sentenced to imprisonment for violating the Act without completing the sentence, or being a person whose registration was cancelled less than 1 year ago.

Deadline, competent office and documents

The deadline is 30 days from the date the change occurred, or 90 days when the address changed because of an administrative district reorganization. Submit the change registration application (electronic filing is allowed) together with the registration certificate and the relevant documents to the Regional Office of Food and Drug Safety (지방식품의약품안전청).

1. Record the date the change occurred and schedule the filing so that it is received within 30 days.
2. Prepare the attachments for each change listed above, together with the registration certificate.
3. If the move places the business under a different regional office, file with the office that has jurisdiction over the new address.
4. The processing period is 10 days, or 7 days for a change of responsible sales manager.
5. The office records the change in the register and notes it on the back of the certificate before returning it.

Qualifications when replacing the responsible sales manager

The responsible sales manager handles quality control, post-market safety management and supervision of the manufacturer's testing from raw material intake to finished product release. The new manager must fall under one of the following:

• A physician under the Medical Service Act or a pharmacist under the Pharmaceutical Affairs Act
• A holder of a bachelor's degree or higher in science and engineering, cosmetic science, Korean medicine, nursing or a similar field
• A holder of an associate degree in a cosmetics-related field such as chemistry, biology or life science with at least 1 year of experience in cosmetics manufacturing or quality control
• A person who completed a specialized training course designated by the Minister of Food and Drug Safety (designated items only)
• A person who passed the customized cosmetics preparation manager examination
• Any other person with at least 2 years of experience in cosmetics manufacturing or quality control

In a business with 10 or fewer regular employees, a qualified representative may perform the manager's duties personally and is then deemed to be the manager. These qualification rules do not apply to a business registered only for import-agency brokerage in e-commerce.

A departing manager may file a notice of no longer engaging in management duties with the regional office. That is the manager's own procedure; the business must still file its change registration with the successor's documents. See also our guide to registering a cosmetics importer.

If you miss the change registration

Failing to register a change is a ground for administrative action under the Cosmetics Act, including business suspension or cancellation of registration, and the sanction becomes heavier with repeated violations. For an unregistered change of representative, trade name or manager, the 1st violation leads to a corrective order, but for an unregistered change of business address the 1st violation already carries a 1-month suspension of sales operations.

If the deadline has passed, align the facts and documents and file as soon as possible. Our registration support is described on the cosmetics registration service page.

Yuseon Administrative Scrivener Office (Chief Scrivener Jeong Yuseon)