Q336 · For returned medicines already assessed as…

Q336 · Category G: Quality management and compliance systems (Q301–Q350)

Even if a batch of returned medicines is initially assessed as ‘possibly’ suitable for resale, it must never be returned directly to the shelves. A series of strict steps must still be completed. First, the decision must be formally approved in writing by an authorised person in the quality department (usually the ‘Responsible Person’ (RP)), and the approval document must set out the basis for the assessment in detail. Second, the stock status of the batch must be correctly updated in the inventory management system, from ‘quarantine/returned’ to ‘released/available for sale’, to ensure that the system record matches the physical status. Its traceability records must also be complete. If the medicine requires serialisation, its serial number status must also be correctly reactivated in the national system. Only after all these document and system steps have been completed may the batch be physically moved back into saleable stock.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Medicinal Products provides that returned medicines may only be considered for return to stock after the designated person has assessed them and confirmed that their quality has not been affected. The entire process must be fully documented to demonstrate that the decision was justified and the handling compliant.

📗 Drew Tang's recommendations

We reiterate that the criteria for reselling returned medicines should be extremely strict. We recommend establishing a “restocking inspection checklist” in your SOP to ensure that every step is carried out and recorded. Treat the RP's written approval as an absolute requirement. In practice, unless you are completely certain, destroying returned goods is the safer and simpler option, as it avoids potential risks and complex paperwork altogether.

📕 Risk notice

Taking shortcuts in any procedure for handling returns may have disastrous consequences. If returned medicines are resold in error without formal approval from the RP and those medicines happen to have a quality issue, the company will face the most serious legal and reputational repercussions. When reviewing returns records, the regulatory authorities will closely scrutinise whether decisions to return goods to stock were made rigorously and whether the documentation is complete.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

For returned medicines already assessed as suitable, what further steps must be completed before they can be returned to stock for sale?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang