Implementation Of Phase III Control Of Chinese Proprietary Medicines(CPM)

26 Sep 2000

To promote safety and quality of Chinese Proprietary Medicines (CPM) available in Singapore, the Ministry of Health has implemented control on the import, manufacture, sale and supply of CPM since 1 September 1999.

The control of CPM requires :

a. local CPM importers, wholesalers, manufacturers and assemblers of CPM to apply for relevant licences from the Ministry of Health;

b. CPM to be labelled with the following details in English:

name of product;

names and quantities of Chinese medicinal ingredients;

batch number and expiry date;

name and address of the manufacturer and

name and address of the importer or wholesaler;

c. dealers to ensure that CPM labels and packaging materials do not make any claims with reference to the 19 specific diseases or conditions prohibited under the Medicines Act, such as cancer and diabetes;

d. dealers to ensure that all CPM do not exceed the permissible limits set for both microbial contamination and toxic heavy metals (arsenic, copper, lead and mercury) and

e. importers to submit documents showing absence of western drugs, and test results of toxic heavy metals and microbial contents at the point of import.

The control of CPM is being implemented in 3 phases. In Sep 99, the Ministry implemented the control on CPM preparations in tablet and capsule forms (phase 1). This control was extended to include CPM oral and external liquid preparations in Sep 2000 (phase 2)

From 1 September 2001, phase 3 control of CPM preparations will take effect. Dealers of CPM preparations other than tablets, capsules and liquid preparations will need to obtain relevant licences. The Ministry has started accepting applications for the relevant licences for CPM under phase 3 control. CPM dealers dealing with phase 3 CPM are advised to submit their applications before 1 March 2001 in order to obtain the necessary licences and product approval by 1 September 2001.

Under the legislation, it is 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 2 years or both.

Guidebooks on CPM control and application forms for licences 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.