Hong Kong Drug Office Publishes Guideline on Pharmaceutical Products Recall

Hong Kong Drug Office has published some guidelines on the recall of pharmaceutical products in March 2022. 

Pharmaceutical products are subjected to a recall when there is suspicion on the potential harm that the products can bring to users or consumers. This may be due to certain circumstances that may have compromised the quality, safety, and efficacy of the product.  

The Drug Office, Department of Health of Hong Kong Special Administrative Region (SAR) must be provided with all the information pertaining to the recall. 

The licensee of a product must inform the Department of Health immediately once a recall is initiated by providing information via the Recall Notification Form (Appendix 1 of the guidelines). 

Each recall case is classified into Class I, II or III, depending on the seriousness. Class I or Class II recalls are safety-related recalls and need to be urgently reported (within 24 hours by telephone). Class III recalls are non-safety-related recalls and need to be reported no later than 72 hours to the Department of Health.  

More details can be found in “Pharmaceutical Products Recall Guidelines, March 2022”: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Pharmaceutical_Products_Recall_Guidelines.pdf  

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