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: Exempts specified categories of traditional/homoeopathic medicines and related substances from certain licensing requirements under the Medicines Act
- Key Provisions (Extract): Sections 2, 2A, 3, 4, 5, 6
- Notable Amendments (Timeline): 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 (“Exemption Order”) is a Singapore subsidiary legislation made under the Medicines Act. Its central function is to carve out exemptions from certain provisions of the Medicines Act—particularly those dealing with licensing and related controls—so that specified products can be sold, supplied, imported, manufactured, assembled, exported, or otherwise handled without the same level of licensing that would ordinarily apply to medicinal products.
In plain terms, the Order recognises that not all products marketed as medicines are treated identically under the Medicines Act. It creates a regulatory “lighter-touch” pathway for (i) Chinese proprietary medicines, (ii) traditional medicines, (iii) homoeopathic medicines, and (iv) certain “quasi-medicinal products” and other specified substances such as medicated oils and balms. The Order also provides targeted permissions for importation and exportation in limited circumstances, including small quantities for personal/family use and controlled importation for re-export.
For practitioners, the Exemption Order is most useful when advising on whether a product falls within the defined categories and, if so, whether licensing obligations under the Medicines Act are disapplied. The legal risk often turns on classification: whether the product is truly “traditional medicine”, “homoeopathic medicine”, “Chinese proprietary medicine”, “quasi-medicinal product”, or “medicated oil and balm”, and whether it contains excluded elements (for example, injection products or certain chemically-defined isolated constituents).
What Are the Key Provisions?
1. Definitions that drive classification (Section 2)
The Order’s definitions are not merely descriptive; they determine the scope of exemptions. For example, “Chinese proprietary medicine” is defined as a medicinal product used in traditional Chinese therapeutics, manufactured into a finished product, containing active substances derived wholly from plant, animal or mineral sources (or combinations), and whose active substances are described in specified reference works (the “current edition” of A Dictionary of Chinese Pharmacy and The Chinese Herbal Medicine Materia Medica). Importantly, the definition excludes products administered by injection and products containing chemically-defined isolated constituents of plant/animal/mineral sources.
Similarly, “traditional medicine” is defined broadly as medicinal products consisting of one or more substances derived from plant, animal or mineral sources (or combinations), but it excludes injection products, vaccines, products derived from human blood, items specified in the Poisons List under the Poisons Act, and—critically—any Chinese proprietary medicine. This exclusion means Chinese proprietary medicines are regulated under the separate exemption regime in Section 2A rather than the general “traditional medicine” exemption in Section 3.
2. Exemption for Chinese proprietary medicines (Section 2A)
Section 2A provides that Section 5(1) of the Medicines Act shall not have effect for certain persons dealing with Chinese proprietary medicines. Specifically, the exemption applies to persons who sell, supply, export, or procure the sale/supply/export, or procure the manufacture/assembly for the purpose of sale/supply/export. In addition, Section 6(4) of the Medicines Act is disapplied for persons who manufacture or assemble Chinese proprietary medicines for sale/supply to others or for export.
Practically, this means that the licensing requirements addressed by Sections 5(1) and 6(4) are not triggered for the defined activities involving Chinese proprietary medicines, subject to the product meeting the definition. For businesses, the key compliance task is evidencing that the product is within the defined category—particularly the reference to the “current edition” of the relevant materia medica/dictionary and the exclusion of injection and isolated constituents.
3. Exemption for other substances (Section 3)
Section 3 is the general exemption provision for categories other than Chinese proprietary medicines. It states that Sections 5 and 6 of the Medicines Act do not apply to persons in respect of selling, offering for sale, supplying, importing, manufacturing, assembling, and wholesale dealing of the following: traditional medicines, homoeopathic medicines, quasi-medicinal products, raw materials used as ingredients in preparing/manufacturing medicinal products, and medicated oil and balm.
Section 3 also contains a specific carve-out: Sections 5 and 6 do not apply to a person dealing with a topical antiseptic that does not contain mercury or any compound of mercury. This is significant because it introduces a chemical-content threshold. Where mercury or mercury compounds are present, the exemption would not apply, and licensing controls under the Medicines Act would likely remain relevant.
4. Importation without licence in limited personal/professional contexts (Section 4)
Section 4 empowers the licensing authority to permit importation of a medicinal product without a product licence or import licence, but only where the import is for one of three purposes: (a) self or family administration, (b) a doctor/dentist importing for administration to their patients, or (c) a pharmacist importing pursuant to a doctor/dentist prescription. The quantity imported must not exceed three months’ supply, based on the dosage recommended by the manufacturer or supplier.
This provision is a “permission-based” mechanism rather than an automatic exemption. Practitioners should treat it as a procedural pathway requiring the licensing authority’s approval, and should ensure the dosage basis and quantity are properly documented to demonstrate compliance with the three-month limit.
5. Import solely for re-export (Section 5)
Section 5 allows the licensing authority to permit importation of a medicinal product solely for re-export without holding a product licence or import licence. The permission is subject to terms and conditions the licensing authority thinks fit. However, the exemption does not apply to imports of topical antiseptics containing mercury or mercury compounds.
For traders and logistics operators, the practical issue is establishing that the import is indeed solely for re-export and complying with any conditions imposed (for example, record-keeping, segregation, and export timelines). The mercury carve-out again highlights that certain antiseptics remain tightly controlled.
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. This is also subject to terms and conditions. The mercury-containing topical antiseptic carve-out applies here as well: the permission does not extend to exports of topical antiseptics containing mercury or mercury compounds.
In practice, this provision is relevant to contract manufacturing and export-only production models. Counsel should focus on whether the manufacturing is truly “solely for export” and whether the product is within the permitted scope, including the mercury content limitation.
How Is This Legislation Structured?
The Exemption Order is structured as a short instrument with a citation provision, definitions, and a set of operative exemption and licensing-permission sections. The main structure is:
(i) Section 1: Citation.
(ii) Section 2: Definitions (including the key product categories and exclusions).
(iii) Section 2A: Exemption from certain Medicines Act provisions for Chinese proprietary medicines.
(iv) Section 3: Exemption from Sections 5 and 6 for other specified categories (traditional medicines, homoeopathic medicines, quasi-medicinal products, raw materials, medicated oil and balm, and a topical antiseptic mercury-free carve-out).
(v) Sections 4–6: Licensing authority permissions for importation/exportation without product/import licences in specified circumstances (personal/family use, doctor/dentist/prescription use; re-export; export of export-only manufactured products), with a mercury-containing topical antiseptic exclusion.
Who Does This Legislation Apply To?
The Order applies to “any person” who engages in the relevant activities covered by the exemptions—such as selling, supplying, importing, manufacturing, assembling, exporting, and wholesale dealing—provided the product falls within the defined categories. This includes manufacturers, assemblers, distributors, wholesalers, retailers, importers, exporters, pharmacists, and medical practitioners, depending on the activity.
For Section 4 (importation without licence), the scope is narrower in terms of purpose and actors: it is limited to importation for self/family administration, by doctors/dentists for their patients, or by pharmacists pursuant to prescriptions. For Sections 5 and 6, the scope is tied to re-export and export-only manufacturing, respectively, and is dependent on the licensing authority granting permission.
Why Is This Legislation Important?
This Exemption Order is important because it directly affects regulatory compliance strategy for traditional and homoeopathic product markets in Singapore. The Medicines Act generally imposes licensing requirements for medicinal products. By disapplying Sections 5 and 6 (and specific sub-sections) for defined categories, the Order reduces licensing friction for legitimate trade in traditional/homoeopathic and related products—while still preserving regulatory boundaries through careful definitions and targeted exclusions.
From a practitioner’s perspective, the most significant value lies in classification and risk management. If a product is misclassified—for example, if it contains excluded isolated constituents, is administered by injection, or contains mercury/mercury compounds in a topical antiseptic—then the exemptions may not apply, and licensing obligations could be triggered. The Order therefore functions as both a compliance guide and a litigation risk filter: it defines the “safe harbour” conditions under which licensing requirements are disapplied.
Finally, the permission-based import/export provisions (Sections 4–6) are operationally crucial for supply chain continuity. Businesses and healthcare professionals may need to import or export products without full licences in limited circumstances. Counsel should advise on documentation and evidence: quantity calculations for the three-month supply limit, proof of prescription/patient administration where relevant, and evidence that imports/exports are solely for re-export or solely for export manufacturing.
Related Legislation
- Medicines Act (Cap. 176) (in particular Sections 5 and 6, and Section 9 as the authorising provision)
- Poisons Act (Cap. 234) (Poisons List in the Schedule, referenced in the definition of “traditional medicine”)
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.