Under the Pharmacy and Poisons Ordinance (Cap. 138), all pharmaceutical products must be registered with the Pharmacy and Poisons Board before being sold or supplied in Hong Kong. The Drug Office of the Department of Health supports the Board by managing the application process through the online Pharmaceutical Registration System 2.0 (PRS 2.0).
To enhance timeliness and efficiency in the review process, the new RTF mechanism will include a 60-day timeframe for applicants to respond to deficiency letters issued at the screening stage. The detailed arrangement is as follows:
- For new applications submitted on or after July 1, 2024:
- After screening, if there is outstanding information, a deficiency letter will be issued. Applicants must respond within 60 days. Failure to do so will result in automatic refusal of the application in the PRS 2.0 system.
- For applications in the screening pool before July 1, 2024:
- If the latest deficiency letter is issued before July 1, 2024, applicants must respond by September 1, 2024. Failure to do so will result in automatic refusal of the application in the PRS 2.0 system.
- If the latest deficiency letter is issued on or after July 1, 2024, applicants have 60 days to respond. Failure to do so will result in automatic refusal of the application in the PRS 2.0 system.
Applicants should ensure that their dossiers are complete before submission or promptly reply to deficiency letters to avoid unnecessary delays in the registration process. Refusal due to non-response does not preclude the submission of a new application for registration.
Link as reference: https://www.drugoffice.gov.hk/eps/upload/eps_news/53570/EN/1/PRC%20Letter%20to%20Trade_Screening%20RTF_Eng_signed.pdf