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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 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 (Western medicines, Chinese proprietary medicines, cosmetic products, contact lens substances, etc)

 

Subsidiary Legislation

Medicines (Advertisement) (Exemption) Order

Medicines (Advertisements by Healthcare Institutions) (Exemption) Order 2004

Medicines (Advertisements of Oral Dental Gums) Regulations

Medicines (Cessation of Application of Act to Medical Devices) Order 2010
Medicines (Chinese Proprietary Medicines) (Exemption) Order

Medicines (Chinese Proprietary Medicines) (Exemption) (Revocation) Order 2012

Medicines (Clinical Trials) Regulations

Medicines (Exemption of Registered Pharmacy from Wholesale Dealer's Licence) Order

Medicines (Export Licence for Psychotropic Substances) Regulations

Medicines (General Sale List) Order

Medicines (Good Manufacturing Practice Certificate – Cosmetic Products) Regulations

Medicines (Good Manufacturing Practice Certificate) Regulations

Medicines (Labelling of Aspirin Products) Regulations

Medicines (Labelling of Chinese Proprietary Medicines) Regulations

Medicines (Labelling) Regulations

Medicines (Licensing, Standard Provisions and Fees) Regulations

Medicines (Medical Advertisements) Regulations

Medicines (Non-Medicinal Products) (Consolidation) Order

Medicines (Oral Dental Gums) (Labelling) Regulations

Medicines (Oral Dental Gums) (Licensing) Regulations

Medicines (Oral Dental Gums) (Specification) Order

Medicines (Orphan Drugs) (Exemption) Order

Medicines (Prescription Only) Order

Medicines (Prescription Oral Dental Gums) Order

Medicines (Product Licence) (Exemption) Order
Medicines (Prohibition of Sale and Supply) Order

Medicines (Prohibition of Sale and Supply) (Amendment) Order 2012

Medicines (Registration of Pharmacies) Regulations

Medicines (Sale and Supply by Pharmacy) Notification 1999

Medicines (Traditional Medicines, Homoeopathic Medicines and Other Substances) (Exemption) Order
Medicines (Traditional Medicines, Homoeopathic Medicines and Other Substances) (Exemption) (Amendment) Order 2012



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 

Subsidiary Legislation

Health Products Act (Commencement) Notification 2007

Health Products (Composition of Offences) Regulations 2011

Health Products (Cosmetic Products - ASEAN Cosmetic Directive) Regulations 2007

Health Products (Good Manufacturing Practice Certificate - Cosmetic Products) Regulations 2011

Health Products (Medical Devices) Regulations 2010

Health Products (Medical Devices) (Exemption) Order 2010

Health Products (Medical Devices) (Amendment) Regulations 2012

Health Products (Medical Devices) (Amendment No.2) Regulations 2012

Health Products (Medical Devices) (Amendment No.3) Regulations 2012



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.

 

Subsidiary Legislation

Poisons Rules

Poisons (Amendment) Rules 2012



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 

Subsidiary Legislation

Medicines (Advertisement and Sale) (Exemption) Order 2004



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.

 

Subsidiary Legislation

Drugs Regulations

Sale of Drugs (Prohibited Drugs) (Consolidation) Regulations

Sale of Drugs (Prohibited Substance – Rhodamine B) Regulations



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.

 

Subsidiary Legislation

Smoking (Control of Advertisements and Sale of Tobacco) (Composition of Offences) Regulations

Tobacco (Control Of Advertisements And Sale) (Labelling) Regulations 2012

Smoking (Control of Advertisements and Sale of Tobacco) (Foreign Newspapers) (Consolidation) Notification

Tobacco (Control of Advertisements and Sale) (Licensing of Importers, Wholesalers and Retailers) Regulations 2010

Tobacco (Control of Advertisements and Sale) (Limits on Certain Substances)(Amendment) Regulations 2012



Last updated on 30 Dec 2013 09:09:16
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