Implementation of Good Distribution Practice for Pharmaceutical Products

The Pharmacy and Poisons Board of Hong Kong (the “Board”) has endorsed the implementation of Good Distribution Practice (“GDP”) for pharmaceutical products in Hong Kong.

The Board has endorsed the Guide to Good Distribution Practice for Pharmaceutical Products (“GDP Guide”), Guidance for Industry: Guide to Good Distribution Practice for Pharmaceutical Products (“Guidance for Industry”) and revised Code of Practice for Holder of Wholesale Dealer Licence (“revised COP”) for the implementation of GDP for pharmaceutical products.

The GDP Guide and the Guidance for Industry will be promulgated on 30 September 2026. For new applications for Wholesale Dealer Licence (“WDL”) and Manufacturer Licence (“ML”) received on or after 30 September 2026, compliance with the GDP Guide will be imposed as one of the licensing requirements.

For existing WDL holders and relevant ML holders engaged in wholesale dealings of pharmaceutical products, compliance with the GDP Guide will be imposed as the licensing condition upon licence renewal on or after 30 September 2028. The revised COP will also take effect on 30 September 2028 and will be gazetted in accordance with section 4B(5) of the Pharmacy and Poisons Ordinance (Cap. 138) in due course.

For further information about the implementation of GDP for pharmaceutical products, please visit the dedicated GDP webpage of the Drug Office at:
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/implementation_of_gdp.html