T/SHSPTA 002-2023 Active
T/SHSPTA 002-2023 Drug license holder's guidelines for sales management and outsourcing
Abstract
This document stipulates the responsibilities of the principal, the agent, and other relevant parties in the entrusted sales activities of drug marketing authorization holders, and clarifies the requirements for personnel, process management, traceability systems, quality audits, pharmacovigilance, after-sales management, emergency response, change control, and file management. This document applies to the operational and management activities involved in the entrusted sales process of drug marketing authorization holders. This document can also serve as a reference for the implementation of entrusted sales activities by traditional Chinese medicine herbal medicine manufacturers.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHSPTA 002-2023 |
| Implement Date | 1970-01-01 |