Statute Details
- Title: Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order
- Act Code: MA1975-OR6
- Type: Subsidiary Legislation (SL)
- Status: Current version as at 27 Mar 2026
- Authorising Act: Medicines Act (Cap. 176), Section 9
- Key Purpose: Provides exemptions and licensing flexibilities for certain traditional medicines, homoeopathic medicines, quasi-medicinal products and related substances
- Key Provisions (from extract): Sections 2, 2A, 3, 4, 5, 6
- Notable Amendments (high level): Amended by S 465/1991, S 499/1998, S 310/2001, S 680/2004, S 712/2012 (effective 1 Jan 2013), S 658/2019 (effective 1 Jan 2020)
What Is This Legislation About?
The Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (“the Order”) is a Singapore subsidiary legislation made under the Medicines Act. In practical terms, it carves out specific categories of products—particularly traditional medicines, homoeopathic medicines, and certain “quasi-medicinal” or topical products—from some of the Medicines Act’s regulatory requirements.
The Medicines Act generally regulates the manufacture, sale, importation and distribution of medicinal products, typically requiring licences and product authorisation. However, the Order recognises that not all products within the broad “medicinal” ecosystem present the same regulatory risks or fall within the same commercial and therapeutic frameworks. Accordingly, the Order provides targeted exemptions from certain provisions of the Act and also creates limited pathways for importation and exportation without product licences in defined circumstances.
For practitioners, the Order is most relevant when advising manufacturers, wholesalers, retailers, importers, exporters, and healthcare professionals on whether a product must be licensed/authorised under the Medicines Act, or whether it can be handled under an exemption. It is also relevant for compliance teams dealing with cross-border supply chains, re-export arrangements, and export-only manufacturing.
What Are the Key Provisions?
1) Definitions that determine the scope of exemptions (Section 2)
The Order’s definitions are crucial because the exemptions depend on whether a product falls within a defined category. The extract provides several key terms:
- Chinese proprietary medicine: A finished medicinal product used in traditional Chinese therapeutics, manufactured into a finished product, containing active substances derived wholly from plant/animal/mineral sources (or combinations), and described in specified reference works (e.g., “A Dictionary of Chinese Pharmacy” or “The Chinese Herbal Medicine Materia Medica”). It excludes injectable products and products containing chemically-defined isolated constituents.
- Homoeopathic medicine: A substance used in homoeopathic therapeutics where disease is treated by minute amounts of substances that, in their undiluted forms, can produce similar symptoms in a healthy human.
- Traditional medicine: Medicinal products consisting of substances derived from plant/animal/mineral sources (or combinations), but excluding injections, vaccines, products derived from human blood, items in the Poisons List schedule, and excluding Chinese proprietary medicines.
- Quasi-medicinal product: A defined set of products that are medicated but not treated as full medicinal products for all regulatory purposes—examples include anti-dandruff preparations, medicated cosmetics for pimples/acne (with specific exclusions), medicated soaps, cough/throat-relief sweets, medicated plasters, sunscreens/suntan preparations, medicated beverages, plant/animal/mineral-derived vitamins/nutritional preparations, and medicated toothpaste. The definition also excludes products containing etretinate or 13-cis-retinoic acid (for the acne/pimples category).
- Medicated oil and balm: External medicated embrocations/creams/ointments/inhalants used mainly for soothing purposes and containing specified active ingredients (e.g., essential oils, fixed plant oils, methyl salicylate, menthol, camphor, peppermint).
These definitions operate as “gateways” to the exemptions. A compliance assessment should therefore begin with classification: what exactly is the product, what are its active substances, and how is it intended to be used (including whether it is injectable, contains isolated constituents, or falls within excluded categories).
2) Exemption for Chinese proprietary medicines (Section 2A)
Section 2A provides a specific exemption from certain provisions of the Medicines Act for Chinese proprietary medicines. In summary:
- Section 5(1) of the Act does not apply to a person who sells, supplies or exports; procures the sale/supply/export; or procures for sale/supply/export the manufacture or assembly of any Chinese proprietary medicine.
- Section 6(4) of the Act does not apply to a person who manufactures or assembles Chinese proprietary medicines for sale/supply to another person, or for export.
Although the extract does not reproduce the text of Sections 5 and 6 of the Medicines Act, the structure indicates that these provisions relate to licensing/authorisation obligations. The effect is that, for Chinese proprietary medicines, certain licensing requirements in the Act are “switched off” for the specified activities and persons.
3) Exemption for other categories (Section 3)
Section 3 extends exemptions more broadly to other product categories. It provides that Sections 5 and 6 of the Act do not apply to a person in respect of selling, offering for sale, supplying, importing, manufacturing, assembling, or wholesale dealing any of the following:
- traditional medicines;
- homoeopathic medicines;
- quasi-medicinal products;
- raw materials used as ingredients in preparing or manufacturing any medicinal product; and
- medicated oil and balm.
Section 3(2) adds a further carve-out: Sections 5 and 6 do not apply to a person selling/handling a topical antiseptic that does not contain mercury or any compound of mercury. This is a targeted risk-based exemption, reflecting that mercury-containing antiseptics may attract stricter controls.
4) Importation without licence—limited quantities and personal/clinical use (Section 4)
Section 4 creates a licensing flexibility for importation of medicinal products without a product licence or import licence. The licensing authority may permit importation where:
- the importer is importing for administering the product to himself or a family member;
- the importer is a doctor or dentist importing for administering to a patient; or
- the importer is a pharmacist importing pursuant to a prescription by a doctor or dentist.
However, the exemption is constrained by quantity: the imported quantity must not exceed 3 months’ supply, based on the dosage recommended by the manufacturer or supplier. This provision is particularly relevant for practitioners dealing with individual patient needs, compassionate supply, or cross-border procurement where formal licensing may be burdensome for small quantities.
5) Import solely for re-export (Section 5)
Section 5 allows the licensing authority to permit a person to import a medicinal product solely for re-export without holding a product licence or import licence, subject to terms and conditions the authority thinks fit. A key limitation is that the permission does not apply to importation of a topical antiseptic containing mercury or any compound of mercury.
6) Export of medicinal products manufactured solely for export (Section 6)
Section 6 similarly allows the licensing authority to permit export of a medicinal product manufactured solely for export without holding a product licence, again subject to terms and conditions. The mercury-containing topical antiseptic exclusion applies here as well.
How Is This Legislation Structured?
The Order is structured as a short set of operative provisions:
- Section 1 sets out the citation.
- Section 2 provides definitions that determine how product categories are identified (including Chinese proprietary medicines, homoeopathic medicines, traditional medicines, quasi-medicinal products, medicated oil and balm).
- Section 2A creates a targeted exemption regime for Chinese proprietary medicines, disapplying specified Medicines Act provisions for defined activities and persons.
- Section 3 creates broader exemptions for other categories (traditional medicines, homoeopathic medicines, quasi-medicinal products, raw materials, medicated oil and balm) and adds a mercury-based carve-out for topical antiseptics.
- Sections 4 to 6 address import/export pathways without licences: personal/clinical import (Section 4), re-export import (Section 5), and export of export-manufactured products (Section 6).
Notably, the Order does not itself create a full licensing framework; rather, it modifies the operation of the Medicines Act by disapplying certain provisions and by empowering the licensing authority to permit specific licence-free import/export scenarios.
Who Does This Legislation Apply To?
The exemptions apply to “any person” engaged in the specified activities—selling, supplying, importing, manufacturing, assembling, and wholesale dealing—provided the product falls within the defined categories. This means the Order is relevant to a wide range of stakeholders: manufacturers and assemblers, wholesalers and retailers, importers and exporters, and businesses handling raw materials for medicinal product preparation.
For the importation and exportation permissions in Sections 4 to 6, the Order also applies to specific professional and commercial actors: individuals importing for self/family use; doctors and dentists importing for patient administration; pharmacists importing on prescription; and importers/exporters seeking re-export or export-only manufacturing arrangements. In all such cases, the licensing authority’s discretion and the stated conditions (including quantity limits and mercury exclusions) are central.
Why Is This Legislation Important?
This Order is significant because it directly affects whether regulated medicinal product activities trigger the Medicines Act’s licensing/authorisation requirements. For practitioners advising clients in the traditional medicine and related sectors, the exemptions can materially reduce compliance burdens—provided the product classification is correct and the activity falls within the exempted scope.
From an enforcement and risk perspective, the most important practical issues are (i) product classification under the definitions in Section 2, and (ii) boundary conditions such as exclusions for injections, vaccines, human-blood-derived products, Poisons List items, and mercury-containing topical antiseptics. Misclassification can lead to the exemptions not applying, exposing the client to regulatory breach.
For cross-border supply chains, Sections 4 to 6 provide controlled flexibility. The 3-month supply limit in Section 4 is a common compliance flashpoint: importers must ensure quantities align with manufacturer/supplier dosage recommendations and remain within the permitted timeframe. Similarly, re-export and export-only manufacturing permissions in Sections 5 and 6 are discretionary and subject to terms and conditions; businesses should expect documentation and audit trails demonstrating that the product is indeed imported solely for re-export or manufactured solely for export.
Related Legislation
- Medicines Act (Cap. 176) (authorising provision: Section 9; operative provisions referenced: Sections 5 and 6)
- Poison Act (Cap. 234) (relevant by reference: Poisons List items excluded from “traditional medicine” definition)
Source Documents
This article provides an overview of the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order for legal research and educational purposes. It does not constitute legal advice. Readers should consult the official text for authoritative provisions.