江西省药监局 recently released a new regulation aimed at standardizing the operations of pharmaceutical companies that are temporarily or permanently ceasing business activities. The Interim Provisions on the Supervision and Administration of停业and Restoration of Pharmaceutical Operating Enterprises in Jiangxi Province introduces stricter requirements for enterprises to follow when they decide to halt operations or resume after a pause.
According to the provisions, pharmaceutical wholesale companies and retail chain headquarters must report to local regulators within 5 working days if they cease operations continuously for over 6 months during the validity period of their business license. The regulations also specify that enterprises intending to resume operations must first conduct internal audits, system verifications, and calibrations before submitting a written application and a self-inspection report on pharmaceutical quality management to the local authorities. Only after passing a现场 inspection will they be allowed to resume operations.
Failure to comply with these reporting requirements or resuming operations without authorization during the停业period will result in strict legal actions. Additionally, if an enterprise fails to report its停业status or neither cancels its license nor applies for restoration within the specified timeframe, regulators will treat it as operating normally and take necessary supervisory measures. Any violations discovered during such inspections will be dealt with according to the law.
责编：戴露露
