Regulations for Medicament Contract Manufacture and Analysis Article 10

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.