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LC: Speech by SFH on proposed resolution under Pharmacy and Poisons Ordinance

     Following is the speech (English translation) by the Secretary for Food and Health, Dr York Chow, in moving a motion on the proposed resolution on Pharmacy and Poisons (Amendment) Regulation 2011 and Poisons List (Amendment) Regulation 2011 under the Pharmacy and Poisons Ordinance in the Legislative Council today (July 6):


     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 a Poisons List under the Poisons List Regulations and several Schedules under the Pharmacy and Poisons 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 eight pharmaceutical products, the Pharmacy and Poisons Board proposes to add the following eight substances to Part I of the Poisons List and the First and Third Schedules to the Pharmacy and Poisons Regulations:

(a)  Clozapine; its salts
(b)  Corifollitropin alfa
(c)  Denosumab
(d)  Fenticonazole; its salts
(e)  Prulifloxacin; its salts; its esters; their salts
(f)  Rasagiline; its salts
(g)  Roflumilast; its salts; and
(h)  Romiplostim

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

     In addition, the Pharmacy and Poisons Board proposes to relax the control of Terbinafine; its salts when contained in preparations for external application only with no more than 1% of Terbinafine and not to be administered as single application and when labelled for the treatment of tinea pedis and/or tinea cruris only; by re-classifying them from Part I of the Poisons List to Part II of the Poisons List only.

     We propose that these amendment regulations take immediate effect upon gazettal on July 8, 2011 to allow early control and sale of the relevant medicine.  

     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 medicine concerned.

     With these remarks, President, I move the motion.

Ends/Wednesday, July 6, 2011
Issued at HKT 17:58


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