Hong Kong Drug Office Publishes Guidance Notes on Registration of Pharmaceutical Products

Hong Kong Drug Office has published some guidance notes on the requirements of pharmaceutical products in February 2022. 

Registration of pharmaceutical products needs to be completed before being sold in Hong Kong and needs to adhere to the Pharmacy and Poisons Regulations.  

If you are a manufacturer outside Hong Kong, registration can be obtained via a licensed wholesale dealer who imports the pharmaceutical product into Hong Kong or a branch, subsidiary, representative, agent, or distributor of the overseas manufacturer. Registration fee is payable when an application is approved and is HKD1,370 per product. 

More details can be found in “Guidance Notes on Registration of Pharmaceutical Products / Substances, February 2022”: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf  

Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News