📘 Regulatory basis
Under PIC/S GMP guidelines, secondary packaging is considered part of manufacturing. Accordingly, such activities require explicit authorisation from the Department of Health and must comply with simplified GMP requirements, also known as “GMP-light”.
📗 Drew Tang's recommendations
If you need to carry out secondary packaging, we will plan for this specifically from the start of the project. We will design a compliant packaging room, draft a complete set of packaging SOPs and guide you on preparing batch packaging records correctly. We will ensure that, when you apply, you can clearly demonstrate to the Department of Health that you are capable of carrying out safe, compliant secondary packaging.
📕 Risk notice
The risk lies in repackaging without authorisation. If you hold only an ordinary Wholesale Dealer Licence but secretly split packs or relabel products in your warehouse, this amounts to serious unlicensed manufacturing. If discovered, the consequences will be severe: your Wholesale Dealer Licence may be revoked, and the company and persons responsible may also face criminal prosecution.