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The Government published in the Gazette today (March 21) the Pharmacy and Poisons (Amendment) Bill 2014, which proposes amending the Pharmacy and Poisons Ordinance (Cap. 138) (PPO) and its subsidiary legislation to strengthen the regulation of pharmaceutical products with a view to providing better protection for the public.
A Government spokesman said, "In the light of a number of incidents concerning pharmaceutical products in Hong Kong in early 2009, the Government set up the Review Committee on Regulation of Pharmaceutical Products in Hong Kong in March 2009 to conduct a comprehensive review on the existing regime for the regulation of pharmaceutical products. In December 2009, the Review Committee made 75 recommendations on improvement measures. The Administration has implemented these recommendations progressively. Among them, 16 recommendations require amendments to be made to the existing PPO and its subsidiary legislation.
"Having thoroughly assessed the impacts of the 16 recommendations which require legislative amendments on the relevant stakeholders and carefully considered their views, the Administration has decided to implement most of the recommendations to enhance the regulatory regime without causing significant impact to the relevant parties. Besides, as certain provisions of the PPO and its subsidiary legislation have become outdated, the Administration has taken this opportunity to propose certain legislative amendments to bring these provisions into line with the prevailing regulatory framework for pharmaceutical products in Hong Kong."
The legislative amendments proposed by the bill involve various aspects including the regulation of manufacturers, importers, exporters, wholesalers and retailers of pharmaceutical products as well as registered pharmacists, and pre-market control of pharmaceutical products. Major proposed amendments are as follows:
* To align with international practice, the definitions of "pharmaceutical product" and "medicine" in the PPO will be revised in accordance with the definitions adopted by the European Union so as to cover also a substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals;
* To empower the Pharmacy and Poisons Board to promulgate corresponding codes of conduct and codes of practice in order to provide practical guidance and enhance monitoring for the conduct of the activities of registered pharmacists, different licensed traders and traders subject to registration requirement (including manufacturers, wholesalers and retailers);
* To clearly stipulate that the secondary packaging of pharmaceutical products should be carried out by licensed manufacturers, and further tighten up the control of the manufacturing of pharmaceutical products. Moreover, each licensed manufacturer will be required to employ at least one authorised person to ensure the quality of pharmaceutical products manufactured;
* To expand the existing licensing mechanism for wholesalers of poisons to cover wholesalers of all pharmaceutical products (including both poisons and non-poisons) as well as to merge the registration of importers/exporters of pharmaceutical products with the licensing of wholesalers in order to standardise and streamline the licensing arrangement. Moreover, the requirement of keeping transaction records of the wholesale of poisons listed in Part I of the Poisons List Regulations will be extended to the wholesale of all pharmaceutical products (including both poisons and non-poisons);
* To tighten up the regulation of the authorised sellers of poisons, including extending the storage requirement of poisons listed in the First Schedule to the Pharmacy and Poisons Regulations to all poisons listed in Part I of the Poisons List Regulations; and
* To streamline the legislative procedure for the registration of pharmaceutical products.
The bill will be introduced into the Legislative Council for scrutiny on March 26.
Ends/Friday, March 21, 2014
Issued at HKT 10:59
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