In
particulars as to dosage and the route and frequency of administration to be printed in both English and Chinese. view of the fact that the majority of consumers in Hong Kong are Chinese, and a large proportion of pharmaceutical products. are imported from overseas countries, such provision is therefore sensible and necessary. There is a grace period of 18 months before the new labelling provisions become effective, in order to allow the pharmaceutical trade the necessary time to
comply.
Whilst welcoming this provision, the Ad Hoc Group feels it desirable to include on the label further information regarding possible contra-indications and side-effects of a product. No doubt many of us are aware that taking the extremes of contra-indications and side-effects, a normally safe pharmaceutical product can become a dangerous poison. Perhaps, there is some truth in the saying that "One man's medicine is another man's poison". Indeed, the Ad Hoc Group is so concerned about this that it urged the Administration to make further amendments to these regulations before submitting them to this Council for approval.
However, the Ad Hoc Group is aware that such
amendments may require consultation and we do not wish to delay the passing of these regulations which contain other important provisions. During a meeting between the Administration and the Ad Hoc Group, we were told that there was an existing channel through which our aim could be achieved.
Under the existing Regulation 36, the Pharmacy and Poison Registration Committee can deregister a pharmaceutical product if it considers it to be in the public interest to do
In dealing with an application for initial registration of a pharmaceutical product, the Committee must take into consideration the factors stated in Regulation 37 which are the
Failure to meet safety, efficacy and quality of the product.
so.
these requirements may result in a refusal to grant a