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This application is a service of the Singapore Government.

Health Sciences Authority

Legislation

medical_legislation

The Health Products Regulation Group administers the following statutes:

Legislation is reproduced on this website with the permission of the Government of Singapore.

HSA has used every reasonable effort to ensure that legislation reproduced in this website is correct at the time of posting. However, as there may be a time lapse between the effective date of amendments and the updating of this website, this website may not contain the latest amendments.

Acts of Parliament are available without charge, and updated monthly, at the Singapore Government Statutes Online website.

Copies of legislation administered by the Health Products Regulation Group are available for purchase from :

Toppan Leefung Pte Ltd.
Legal Publishing
1 Kim Seng Promenade #18-01/06 Great World City East Tower
Singapore 237994
Tel: 6826 9600
E-mail: legalpub@toppanleefung.com
Website: http://www.toppanleefung.com

 

The Health Products Act and its Regulations

The Health Products Act was introduced in 2007. The purposes of this Act are:

  • to provide for the categorisation of health products in accordance with their different characteristics and uses;
  • to provide the framework for a uniform approach for the registration of health products; and the regulation of the manufacture, import, supply, storage, presentation and advertisement of health products
  • to allow for each category of health product to be registered and regulated by reference to its formulation, composition, design specification, quality, safety and efficacy and within the framework provided by this Act; and
  • to prescribe the standards for health products in relation to their formulation, composition, design specification, quality, safety, efficacy and presentation
Currently the four categories of health products regulated under this Act are:
 
  • Medical Devices
  • Cosmetics
  • Therapeutic Products (formerly known as western pharmaceutical drugs)*, and
  • Oral Dental Gums*

    *in effect from 1 November 2016

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The Medicines Act and its Regulations

The Medicines Act was gazetted in 1977 to provide a comprehensive control of all aspects of dealings in medicinal and its related products (Chinese proprietary medicines, traditional medicines, etc)

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The Poisons Act and its Rules

The Poisons Act which was first gazetted in 1939, regulates the importation, possession and sales of potent medicinal substances (poisons) so as to prevent misuse or illicit diversion of poisons. Poisons are listed under the Poisons Act and are identified by their chemical or generic names. The Poison Rules which are made under the Poisons Act serves to ensure the general safe handling of poisons.

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The Medicines (Advertisement and Sale) Act

The Medicines (Advertisement and Sale) Act was introduced in 1956 for two purposes:

  • to curb the proliferation of spurious and misleading advertisements for medicines and medical services, and
  • to regulate the sale of substances recommended as a medicine

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Sale of Drugs Act

The Sale of Drugs Act was first introduced in 1919 as the Sale of Food and Drugs Ordinance which was operated by the Municipality of Singapore. In 1973, the law was vertically split into the Sale of Food Act and the Sale of Drugs Act. The Sale of Food Act was then delegated to the Ministry of the Environment while the Sale of Drugs Act was delegated to the Ministry of Health.

The purpose of the Sale of Drugs Act is to ensure that consumers are supplied with the quantity and quality of drugs demanded by them, explicitly or implicitly.

Thus the sale of adulterated drugs is an offence only when the purchaser is not fully informed of the nature of the adulteration at the time of purchase; and that only under certain circumstances may a drug be presumed to be adulterated or that it be deemed to be sold for human consumption.

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Tobacco (Control of Advertisements and Sale) Act

The Tobacco (Control of Advertisements and Sale) Act, previously known as the Smoking (Control of Advertisments and Sale of Tobacco) Act, was enacted with the objective to bring down the prevalence of smoking among the public, in particular, the under-18 minors.

This Act, amongst other things, restrict accessibility of tobacco products to under-18 minors, inform public of the health hazards of smoking via health warning labels on tobacco packs, prohibit advertisements and sales promotion of tobacco products and limit tar and nicotine contents in cigarettes for sale locally.

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