Replies to LegCo questions

LCQ17: Deregistration of pharmaceutical products

Following is a question by the Dr Hon Kwok Ka-ki and a written reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (March 14):

Question:

I have learnt that a number of imported drugs have been deregistered recently by the Pharmacy and Poisons Board. In this connection, will the Government inform this Council:

(a) whether the agents of deregistered drugs are liable to buy back the drugs concerned from doctors, pharmacies and hospitals; if so, whether the authorities will provide assistance to doctors, pharmacies and hospitals when the agents refuse to buy back the drugs; and

(b) of the measures the authorities have in place to prevent doctors, pharmacies or hospitals from being inconvenienced or suffering losses because of sudden deregistration of drugs?

Reply:

Madam President,

A few months ago the Registration Committee (the Committee) under the Pharmacy and Poisons Board (the Board) deregistered more than ten pharmaceutical products. These products were common generic drugs, the registration of which were held by three companies. The quantity involved was not large and there were substitutes in the market. Last year, it came to the attention of the Committee that the holders of the registration certificates for these pharmaceutical products no longer operated at the addresses stated on the registration certificates. The Committee had made many attempts to contact the three companies and the persons concerned, including seeking assistance from the wholesale dealer, but to no avail. Having sought legal advice, the Committee had to deregister the pharmaceutical products on the ground that the holders of the registration certificates no longer existed. The deregistration did not concern drug safety. Our consolidated reply to the two parts of the question is as follows-

Under Regulation 36(1) of the Pharmacy and Poisons Regulations (PPR), no person shall sell, offer for sale or distribute or possess for the purposes of sale, distribution or other use any pharmaceutical product unless the product is registered with the Board. As the pharmaceutical products in question had been deregistered, the Department of Health (DH) wrote to the wholesale dealer concerned, informing it of the deregistration of the pharmaceutical products, explaining the requirements under Regulation 36(1) of the PPR, and requesting it to withdraw the products from its distribution network.

To assist the stakeholders to learn about the deregistration at the earliest opportunity so as to facilitate the withdrawal, the DH also wrote to those who might have purchased the pharmaceutical products, including medical practitioners, hospitals and drug retailers. If in doubt, these parties might make enquiry with the DH.

The aforementioned case does not concern drug safety. If however any pharmaceutical product is found to be dangerous or injurious to health, the authority will deregister the product in accordance with the PPR and the wholesale dealer and manufacturer will be required to carry out a rapid and, so far as practicable, complete recall of the pharmaceutical product with safety problem by using the system of control they set up in compliance with the PPR and monitor the recall.


Ends/Wednesday, March 14, 2007
Issued at HKT 12:20

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