Control Of Chinese Proprietary Medicine
17 September 1999
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17 Sep 1999
To safeguard the quality and safety of Chinese Proprietary Medicine (CPM) available in Singapore, the Ministry of Health has implemented new controls on the import, manufacture, sale and supply of CPM with effect from 1 Sep 99.
The new controls require:
Local CPM importers, wholesalers, manufacturers and assemblers of CPM to apply for relevant licences from the Ministry of Health
Dealers to label CPM with the Chinese medicinal ingredients, batch number, expiry date, name and address of the manufacturer and name and address of the importer or wholesaler;
Dealers to ensure that CPM labels and packaging materials do not make any claims with reference to the diseases or conditions prohibited under the Medicines Act, such as cancer, diabetes and others;
Dealers to ensure that all CPM do not exceed permissible limits set for microbial contamination nor the current limits set on toxic heavy metals (arsenic, copper, lead and mercury) and
Importers to submit documents showing absence of western drugs, and test results of toxic heavy metals and microbial contents.
The new controls are being implemented in 3 phases over 3 years. Phase 1 of implementation covering CPM tablets and capsules has taken effect from 1 September 1999. In September 2000, CPM control will be extended to liquid preparations. In the third phase in September 2001, the control will cover all CPM.
Under the new legislation, it will be an offence to import, manufacture, sell or supply CPM that do not meet the specified requirements. The penalty for such an offence, upon conviction, is a fine not exceeding $ 5,000 or imprisonment for a term not exceeding two years or both.
Application forms for licences and guidebooks can be obtained from the Chinese Proprietary Medicine Unit, National Pharmaceutical Administration, 2 Jalan Bukit Merah, Singapore 169547.
For further information, the public may contact the Ministry's CPM unit at telephone number 3255452.