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
- Commencement Date: Not stated in the extract (see legislative history for effective dates of amendments)
- Authorising Act: Medicines Act (Cap. 176), referenced in the extract as “Medicines Act (CHAPTER 176, Section 9)”
- Key Provisions:
- Section 2: Definitions and interpretive guidance (“unless the context otherwise requires”).
- Section 2A: Exemption from certain provisions of sections 5 and 6 of the Medicines Act for Chinese proprietary medicines.
- Section 3: Exemption from sections 5 and 6 of the Medicines Act for other specified substances/products.
- Section 4: Licensing authority may permit importation without product/import licence in limited personal/clinical contexts (subject to quantity limits).
- Section 5: Licensing authority may permit importation solely for re-export without licences (with an exception for mercury-containing topical antiseptics).
- Section 6: Licensing authority may permit export of medicinal products manufactured solely for export without holding a product licence (with an exception for mercury-containing topical antiseptics).
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. Its central function is to carve out specific categories of traditional, homoeopathic, and related products from certain licensing requirements that would otherwise apply under the Medicines Act.
In plain language, the Order recognises that not all “medicinal products” are regulated in the same way in practice. It therefore provides exemptions so that certain products—such as traditional medicines, homoeopathic medicines, quasi-medicinal products, medicated oils and balms, and raw materials used to make medicinal products—can be sold, supplied, imported, manufactured, assembled, or dealt with (including wholesale dealing) without triggering the same licensing provisions that apply to other medicinal products.
The Order also addresses cross-border movement of medicines. It gives the licensing authority discretion to permit importation without a product licence or import licence in limited circumstances (for personal use, for doctors/dentists to treat patients, and for pharmacists under prescription), and it allows importation solely for re-export and export of products manufactured solely for export, again without holding certain licences—subject to conditions and specific exclusions.
What Are the Key Provisions?
1) Definitions that determine the scope of exemptions (Section 2)
The exemptions turn heavily on how key terms are defined. Section 2 defines, among other things, “Chinese proprietary medicine”, “homoeopathic medicine”, “medicated oil and balm”, “quasi-medicinal product”, and “traditional medicine”. These definitions are not merely descriptive; they act as gatekeepers for whether a product qualifies for exemption.
Chinese proprietary medicine is defined as a finished medicinal product used in traditional Chinese therapeutics, containing active substances derived wholly from plant, animal, or mineral sources, and described in specified reference works (the “current edition” of A Dictionary of Chinese Pharmacy and The Chinese Herbal Medicine Materia Medica). Importantly, it excludes: (i) injectable products; and (ii) products containing chemically-defined isolated constituents. This exclusion is crucial for compliance—products that are injectable or contain isolated constituents may fall outside the exemption.
Traditional medicine is defined broadly as medicinal products consisting of one or more substances derived from plant, animal or mineral sources, but it excludes: injectable products, vaccines, products derived from human blood, items in the Poisons List under the Poisons Act, and—critically—Chinese proprietary medicines. This means Chinese proprietary medicines are treated separately under Section 2A, not under the general “traditional medicine” exemption in Section 3.
Quasi-medicinal products include categories such as anti-dandruff preparations, medicated cosmetics for pimples/acne (with exclusions for etretinate or 13-cis-retinoic acid), medicated soaps, cough/throat-relief sweets, medicated plasters, sunscreens/suntan preparations, medicated beverages, certain vitamin/nutritional preparations from natural sources, and medicated toothpaste. The definition is product-type driven, so classification matters for licensing outcomes.
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 covers persons who: (a) sell, supply or export; (b) procure the sale, supply or export; or (c) procure for sale, supply or export the manufacture or assembly of Chinese proprietary medicines.
Section 2A(2) further provides that Section 6(4) shall not have effect for persons who manufacture or assemble Chinese proprietary medicines for sale or supply to others, or for export. Practically, this means that for Chinese proprietary medicines, the Order removes the effect of particular licensing provisions that would otherwise regulate sale/supply/export and manufacturing/assembly.
For practitioners, the key compliance task is to confirm that the product truly meets the statutory definition of “Chinese proprietary medicine” (including the reference-material requirement and the exclusions for injectables and chemically-defined isolated constituents). If the product is misclassified, the exemption may not apply.
3) Exemption for other substances and product categories (Section 3)
Section 3 is the general exemption provision for “other substances”. It states that Sections 5 and 6 of the Medicines Act do not apply to a person in respect of specified activities—selling, offering for sale, supplying, importing, manufacturing, assembling, and wholesale dealing—relating to:
- (a) traditional medicines;
- (b) homoeopathic medicines;
- (c) quasi-medicinal products;
- (d) raw materials used as ingredients in preparation/manufacture of any medicinal product; and
- (e) medicated oil and balm.
Section 3(2) adds a further targeted exemption: Sections 5 and 6 do not apply to a person dealing in a topical antiseptic that does not contain mercury or any compound of mercury. This is a compliance-critical carve-out because mercury-containing topical antiseptics are excluded from the exemption.
Practical implication: Section 3 is not limited to domestic sale. It expressly includes importing and manufacturing/assembling and wholesale dealing. Therefore, businesses importing or manufacturing these categories may be able to operate without the Medicines Act licensing provisions that would otherwise apply, but only if the product fits squarely within the defined categories and the mercury condition (where relevant) is satisfied.
4) Importation without licence in limited circumstances (Section 4)
Section 4 provides discretionary relief. The licensing authority may permit importation of any medicinal product without a product licence or import licence if the import is for one of three purposes:
- (a) by any person for administering the medicinal product to himself or a family member;
- (b) by a doctor or dentist for administering to a patient; or
- (c) by a pharmacist pursuant to a prescription by a doctor or dentist.
However, the quantity imported must not exceed 3 months’ supply based on the dosage recommended by the manufacturer or supplier. This provision is particularly relevant for cross-border personal medicine arrangements, clinical treatment needs, and prescription-based procurement. It also creates a clear quantitative compliance threshold that can be audited.
5) Import for re-export without licences (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 licensing authority thinks fit. This is a typical trade facilitation mechanism, but it is discretionary and conditional.
Section 5(2) excludes from this relief the import of topical antiseptics containing mercury or any compound of mercury. In other words, even if the goods are intended for re-export, mercury-containing topical antiseptics remain subject to stricter controls.
6) Export of products manufactured solely for export without product licence (Section 6)
Section 6 mirrors Section 5 for outbound trade. The licensing authority may permit a person to export a medicinal product manufactured solely for export without holding a product licence, again subject to terms and conditions. This facilitates manufacturers who produce for foreign markets only.
Section 6(2) again excludes mercury-containing topical antiseptics from the relief. For exporters, the compliance focus is on both the “manufactured solely for export” condition and the mercury exclusion.
How Is This Legislation Structured?
The Order is structured as a short instrument with a definitions section and six operative provisions:
- Section 1 sets out the citation.
- Section 2 provides definitions for key product categories and interpretive terms.
- Section 2A creates a specific exemption regime for Chinese proprietary medicines, targeting particular Medicines Act provisions (Sections 5(1) and 6(4)).
- Section 3 creates a broader exemption for traditional medicines, homoeopathic medicines, quasi-medicinal products, raw materials used as ingredients, and medicated oil and balm, and includes a targeted exemption for certain mercury-free topical antiseptics.
- Section 4 addresses importation without licences in limited personal/clinical/prescription contexts, with a 3-month supply limit.
- Section 5 addresses importation solely for re-export without licences, with a mercury-containing topical antiseptic exclusion.
- Section 6 addresses export of products manufactured solely for export without a product licence, with the same mercury-containing topical antiseptic exclusion.
Who Does This Legislation Apply To?
The exemptions apply to “any person” engaged in the relevant activities—selling, supplying, exporting, procuring manufacture/assembly, importing, manufacturing, assembling, and wholesale dealing—so long as the activities relate to the specified product categories. This includes manufacturers, assemblers, wholesalers, retailers, importers, exporters, and intermediaries who procure transactions.
For Sections 4 to 6, the licensing authority’s discretion applies to importers/exporters and, in the case of Section 4, also to individuals and healthcare professionals (doctors/dentists) and pharmacists acting under prescriptions. The relief is not automatic; it is conditional on meeting the statutory purpose and quantity limits (Section 4) or on the “solely for re-export” / “manufactured solely for export” conditions (Sections 5 and 6), plus any terms and conditions imposed by the licensing authority.
Why Is This Legislation Important?
This Order is important because it materially affects the regulatory burden for a wide range of products that are commonly traded and used in Singapore, particularly traditional and homoeopathic products and related consumer items. By removing the effect of certain licensing provisions of the Medicines Act for defined categories, it enables market access and supply-chain operations without requiring the same licensing steps that apply to other medicinal products.
From a practitioner’s perspective, the Order’s value lies in its classification-driven approach. The exemptions depend on whether the product fits the statutory definitions (for example, whether a product is a “Chinese proprietary medicine” versus “traditional medicine”, and whether it is injectable or contains chemically-defined isolated constituents). Misclassification can lead to regulatory non-compliance.
Additionally, the cross-border provisions (Sections 4 to 6) provide practical pathways for legitimate import/export activity without full licensing, but they are bounded by clear conditions: the 3-month supply limit for personal/clinical importation, the “solely for re-export” and “manufactured solely for export” limitations, and the consistent exclusion of mercury-containing topical antiseptics. These boundaries are likely to be central in enforcement and in applications to the licensing authority.
Related Legislation
- Medicines Act (Cap. 176) (particularly Sections 5 and 6 referenced by the Order)
- Poison Act (Cap. 234) (Poisons List 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.