On Jan. 1, 2023, China National Medical Products Administration (NMPA) started to implement Sixth Appendix to Good Supply Practices (GSP) for Pharmaceuticals: Quality Management of Drug Retail Delivery (hereafter referred to as the Appendix).
The Appendix applies to the delivery after drug retail transactions, including online transactions.
The quality management requirements in the Appendix cover personnel, internal review system, delivery entrustment, delivery methods, packaging, return of goods, etc.
It is the first time that China has clearly permitted online retailers to entrust drug delivery services to a third party.1
Quality Management System
Drug retailers shall establish a quality management system for drug delivery, audit the system periodically, and update the system in time. The system shall cover:
- Personnel management;
- Position responsibilities;
- Equipment;
- Standard operating procedure (SOP);
- Records and accounting documents;
- Emergency management, etc.
Retailer’s internal audit should take place at least once a year. The audit result is based on the quality issues and comments collected by the retailer company and/or from the customer feedback. With the audit result, the retailer shall improve relevant documents of the system and train corresponding professionals to improve the quality management during delivery.
Third-party online drug sales platforms shall audit the delivery partners at least once a year. If the delivery company fails the audit, the platform should terminate the partnership.
Drug Delivery Personnel
Drug retailers shall assign full-time or part-time persons responsible for quality management during drug delivery. The persons shall be familiar with relevant regulations and able to make independent and correct judgements during the delivery to ensure compliance with the regulations.
Delivery persons for cold or frozen drugs shall receive trainings on relevant regulations and professional knowledge. Only after passing the qualification test can the trainees engage in cold chain delivery.
Tool, Device, and Package for Delivery
Drug retailers shall choose appropriate tools, devices, and packages based on business type, business scope, and delivery time limit.
For example, delivery vehicles shall have a sealed container. In the container, the drugs shall be put in a separate part from non-drug goods, but are not required to be separated from medical devices and health supplements.
Entrusted Delivery
If entrusting the delivery service to a third party, the drug retailer shall include the entrusted delivery in its quality management system. The retailers shall fulfill the following obligations:
- Verifying if the entrusted company has an independent drug delivery quality management organization or a responsible person for quality;
- Periodically auditing the delivery company’s equipment, personnel, quality assurance capability, and risk control capability;
- Signing an agreement with the delivery company. The agreement shall specify the two parties’ respective responsibilities, SOP for delivery, transit time limit, safety event handling, etc.
- If entrusting delivery of cold/frozen drugs, the retailer shall also validate the entrusted company’s delivery equipment and automatic temperature monitoring system.
Return of Goods
There are two scenarios that drug retailers shall agree the return of delivered drugs:
(1) When the drug is delivered to the customer, the customer rejects signing the package because of the damage of package or sealing label, inconsistency between the order and the delivery, and/or quality issues with the delivered drug. In such a situation, the drug shall be taken back to the retailer.
If the sold drug has severe quality issues, the retailer shall immediately recall the sold drug, take a record, and report to the medical products administration.2
(2) The retailer shall agree the return of the drug if the customer finds a quality issue after signing the package. The returned drugs shall not be sold again.
Except the two above scenarios, drug retailers can reject the return of drugs.
BaiPharm’s Comment
The demand for drug delivery is expected to rise as China permits prescription drugs to be sold online since Dec. 1, 2022. With the GSP Appendix, China allows flexibility for retailers to outsource delivery services. At the same time, China keeps stringent about quality management by detailing the obligations for drug retailers, delivery companies, and third-party online drug sales platforms.
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