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LC: Speech by SFH on proposed resolution under Pharmacy and Poisons Ordinance
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Following is the speech by the Secretary for Food and Health, Dr Ko Wing-man, in moving a motion on the proposed resolution on the Pharmacy and Poisons (Amendment) Regulation 2014 and the Poisons List (Amendment) Regulation 2014 under the Pharmacy and Poisons Ordinance in the Legislative Council today (March 19):

Mr President,

I move that the motion under my name, as printed on the Agenda, be passed.

Currently, we regulate the sale and supply of pharmaceutical products through a registration and monitoring system set up in accordance with the Pharmacy and Poisons Ordinance. The Ordinance maintains several Schedules under the Pharmacy and Poisons Regulations and a Poisons List under the Poisons List Regulations. Pharmaceutical products put under different parts of the Poisons List and different Schedules are subject to different levels of control in regard to the conditions of sale and keeping of records.

For the protection of public health, some pharmaceutical products can only be sold in pharmacies under the supervision of registered pharmacists and in their presence. For certain pharmaceutical products, proper records of the particulars of the sale must be kept, including the date of sale, the name and address of the purchaser, the name and quantity of the medicine and the purpose for which it is required. The sale of some pharmaceutical products must be authorised by prescription from a registered medical practitioner, dentist or veterinary surgeon.

Arising from an application for registration of seven pharmaceutical products, the Pharmacy and Poisons Board proposes to add the following substances to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations:

(a) 5-aminolevulinic acid; its salts; its derivatives; their salts;
(b) Cobicistat; its salts;
(c) Elvitegravir; its salts;
(d) Lixisenatide;
(e) Mifepristone; its salts; its esters; their salts;
(f) Perampanel; and
(g) Pertuzumab.

Pharmaceutical products containing the above seven substances must then be sold in pharmacies under the supervision of registered pharmacists and in their presence, with the support of prescriptions.

For amendment regulations concerning the adding of the above seven substances to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations, we propose them to take immediate effect upon gazettal on March 21, 2014, to allow early control and sale of the relevant medicines.

The two Amendment Regulations are made by the Pharmacy and Poisons Board, which is a statutory authority established under the Ordinance to regulate pharmaceutical products. The Board comprises members engaged in the pharmacy, medical and academic professions. The Board considers the proposed amendments necessary in view of the potency, toxicity and potential side effects of the medicines concerned.

With these remarks, Mr President, I hope members could support the motion.

Thank you.

Ends/Wednesday, March 19, 2014
Issued at HKT 18:43

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