A contract manufacturer shall be a medicinal product factory in compliance with the Regulations Governing Good Manufacturing Practices for Medicinal Products.

The contract party shall firstly find a contract manufacturer, then fill in an application and attach the contract for manufacturing signed by the two parties and related documents, and apply to the central competent health authority for approval.

The labeling and packaging of a drug (medicinal) product that has been approved for contract manufacturing shall conform with the Act and related laws and regulations, and in addition, shall include the name and address of the contract party and the contract manufacturer. With the approval of the competent central health authority, however, the name of the country where the contract manufacturer is located may be used in lieu of the contract manufacturer's name and address.
The usage instructions for the drug (medicinal) product of the preceding paragraph shall conform to the Act and related laws and regulations, and in addition, the contract party and the contract manufacturer shall be respectively indicated, including the names and addresses of each.

Extension of the effective term of the license for a drug (medicinal) product that has been approved for contract manufacturing shall be carried out by the holder of the license in accordance with the provisions of the Act, related laws and regulations.