Replies to LegCo questions
LCQ17: Statutory Labelling requirements for pharmaceutical products
Following is a question by the Hon Andrew Cheng and a written reply by the
Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council
today (October 26):
Question :
Regarding the drugs sold in Hong Kong, will the Government inform this Council:
(a) whether the language used in the labels and product description of drugs is
subject to regulation by existing legislation and administrative arrangements;
(b) among those drugs which may be sold in the absence of pharmacists or without
doctors' prescription, of the number and percentage of those carrying labels and
product description in Chinese;
(c) whether it has assessed the extent of inconvenience caused to users by drugs
not carrying labels and product description in Chinese, and if the lack of such
labels and description has led to improper use of drugs; and
(d) whether legislative amendments will be introduced to stipulate that all
drugs must carry labels and product description in Chinese; if so, when such
amendments will be introduced; if not, the reasons for that, and the measures in
place to help patients and their family members who can read Chinese only to
understand the information about the drugs to be taken?
Reply:
Madam President,
(a) The Pharmacy and Poisons Ordinance (PPO) stipulates the statutory labelling
requirements for pharmaceutical products sold in Hong Kong. In addition, the
Pharmacy and Poisons Board (PPB), which is the statutory body set up under the
PPO, has promulgated administrative guidelines in relation to drug labelling for
the purpose of registration approval for the drug.
In accordance with the statutory and administrative requirements, all drugs are
required to be labelled with general information covering name of the product,
name and quantity of each active ingredient, name and address of the
manufacturer, specific storage conditions, if any, Hong Kong registration
number, batch number and expiry date. Information in respect of administration
of non-prescription drugs which are readily available over the counter is also
required to be set out.
At present, the statutory and administrative requirements contain provisions in
respect of the language requirements on the labelling information.
There is no requirement obligating the provision of package insert and the
content of such inserts.
(b) For non-prescription drugs which are readily available over the counter,
they all have to comply with the language requirement in respect of storage
conditions and drug administration which has to be bilingual. For those which
contain a package insert, we understand roughly about 40% of such inserts are in
Chinese.
(c & d) Prescribed / supervised pharmaceutical products are not required to
contain bilingual labelling on drug administration. In providing a prescription
or dispensing a drug, the doctor or the pharmacist, as the case may be, is
professionally obligated to ensure that the user is provided with the necessary
usage and precaution information concerning the drug in question so that it will
be administered safely and effectively.
We are not aware of these arrangements causing inconvenience to drug users and
improper use of drugs. Nonetheless, the PPB will review from time to time the
adequacy of the labelling requirements, with a review to seeking improvements.
The PPB will consult the stakeholder groups as appropriate, and will consider
whether any new labelling requirements should best be introduced through
administrative or legislative amendments.
Ends/Wednesday, October 26, 2005
Issued at HKT 17:06
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