New medicine labelling requirements to take effect from August 5, 2016
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According to section 27 of the PPO, no person shall sell any poison unless the container is labelled in accordance with the Pharmacy and Poisons Regulations (Cap 138A) (PPR). Under the PPR, the container of a poison-containing pharmaceutical product must be clearly printed with both English and Chinese text as specified in Schedule 5 in respect of the kind of poison contained. The text must not be modified in meaning by the addition of any other text or marks.
Depending on the sale restriction, the new labelling requirements are:
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- For medicine containing a poison included in Schedule 3 of the PPR, it must be labelled with the text "Prescription Drug BÙÍ´¹»µª "; and
- For medicine containing a poison included in Part 1 of the Poisons List but not in Schedule 3 of the PPR, it must be labelled with the text "Drug under Supervised Sales ýÿ
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The Drug Office of the DH has issued letters to the pharmaceutical trade and relevant associations to remind them of the above requirements, and has updated the Guidelines on the Labelling of Pharmaceutical Products online.
The amended PPO, with exceptions on the labelling of pharmaceutical products containing poisons, has been in operation since February 2015 and 18 months have been reserved for the pharmaceutical trade to prepare for the above requirements before their commencement on August 5, 2016.
"From August 5, 2016 onwards, we will take enforcement actions for contravention of the above new labelling requirements. The maximum penalty is a fine of $100,000 and two years' imprisonment upon conviction. We urge the pharmaceutical trade to comply with the new requirements in response to recommendations of the former Review Committee on the Regulation of Pharmaceutical Products in Hong Kong which reinforce our local regulatory framework," a spokesman for the DH said.
Ends/Monday, July 25, 2016
Issued at HKT 16:31
Issued at HKT 16:31
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