Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 10

A medicament manufacturer that suspends business operations shall deliver the certificate originally obtained to the local health authority and the certificate will be in the custody of it, which shall return the certificate when the manufacturer resumes business; if the certificate is not delivered to the local health authority, the central competent health authority may directly proceed to cancel the certificate.A medicament manufacturer that terminates business operations shall report to and request the central competent health authority to revoke its medicament manufacturing license and return the certificate that it originally obtained; if the manufacturer fails to return the certificate, the central competent health authority may directly cancel the certificate.A medicament manufacturer that applies to resume business operations shall apply for an inspection in accordance with the Regulations of Medicament Manufacturer Inspection, and may only resume manufacturing operations after passing the inspection.When it is at the expiration of the period of suspension of business operations, if the manufacturer does not take measures to continue the period of suspension, terminate business operations, or resume business operations, and it is verified that the manufacturer does not engage in business operations, the central competent health authority shall revoke its medicinal product manufacturing license and cancel the certificate originally obtained.The provisions of the preceding paragraph apply to a foreign manufacturer of imported medicaments when it is verified that the manufacturer does not engage in business operations.