Traditional Medicines & OTC Products
Want to know more about traditional medicines and OTC products in Singapore? Read on! Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Chinese proprietary medicines, traditional (Indian and Malay) medicines, homeopathic medicines and medicated oils and balms are regulated under the Medicines Act (Chapter 176), the Medicines (Advertisement and Sale) Act (Chapter 177), the Sale of Drugs Act (Chapter 282) and the Poisons Act (Chapter 234) and their subsidiary legislation, which fall under the regulatory purview of the Health Sciences Authority (HSA).
Persons who sell, supply or export Chinese proprietary medicines, or who procure Chinese proprietary medicines for sale, supply or export, are exempted from licensing requirements. However, persons that intend to import, distribute as a wholesaler or manufacture Chinese proprietary medicines in Singapore must respectively obtain an import licence, a wholesale dealer’s licence and a manufacturer’s licence.
Traditional medicines, homoeopathic medicines and medicated oils and balms are not presently subject to licensing for their manufacture, import and sale in Singapore. However, dealers of such products such as manufacturers, importers, wholesale dealers and sellers are responsible for the safety and quality of the products which they deal with.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Generally, yes. However, Chinese proprietary medicines, traditional (Indian and Malay) medicines, homeopathic medicines and medicated oils and balms are subject to advertisement controls, and an advertising permit and approvals may be required from the HSA prior to advertising such products if the advertisement contains any medicinal or therapeutic claims.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
General health claims may be used in the advertisement of traditional medicinal materials, based on traditional or long-standing use, as documented in approved traditional medicine literature. However, such products cannot be advertised with any direct or indirect reference to any of the 19 prohibited diseases and conditions specified in the Schedule to the Medicines Act, namely, blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney diseases, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency, frigidity as well as conception and pregnancy. In addition, no efficacy claims are allowed for serious medical diseases, disorders and conditions, including osteoporosis, insomnia, hepatitis, thyroid disorders, heart or cardiovascular diseases, genetic disorders, infectious diseases and sexually transmitted diseases.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Over the counter medications, or general sales list (GSL) medicines, are regulated as “therapeutic products” under the Health Products Act and its subsidiary legislation. Such products will generally need to be registered with the HSA before they are supplied in the Singapore market.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC medicines can generally be purchased from any retailer.
It is also possible to purchase OTC medicines from automatic vending machines, provided that the following statutory requirements are met:
- the person’s name and contact information are prominently displayed on the automatic vending machine;
- the automatic vending machine is sufficiently equipped and secure to ensure appropriate storage conditions for the medicine;
- the medicine is labelled and packaged in accordance with the conditions attached by the HSA to the registration of the medicine under the Health Products Act;
- the package size of the medicine is the same as the package size specified for the registration of the medicine, and the total amount of the medicine in each package does not exceed a total dosage of 3 months per individual.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising and marketing claims made in relation to OTC medicines must comply with the applicable legislative requirements including those under the Health Products (Advertisement of Therapeutic Products) Regulations 2016. Such claims should provide factual information about the OTC medicine, and any advertisements must be aligned with the intended uses or indications of the OTC medicine as registered with the HSA. Any text, emphasis, certification, award or unique feature or prominence of an advertised OTC medicine must be substantiated by facts or robust objective evidence from credible sources, such as articles published in scientific or medical journals. Information must be presented in a balanced, objective and accurate manner and must be referenced by reflecting the appropriate citations (where relevant). Any scientific terminologies used should be in a manner that is readily understood by the targeted audience.
7. Can OTC products be marketed or advertised directly to the public?
Generally, yes, provided that the restrictions set out under Health Products Act and its subsidiary legislation such as the Health Products (Advertisement of Therapeutic Products) Regulations 2016 are complied with. For instance, advertisements of OTC medicines must not discourage the reader from seeking medical or professional advice or encourage inappropriate or excessive use of the medicine. Any sales promotions of OTC medicines to the public must not offer a prize as an inducement to purchase the therapeutic product, offer any other health product or medicinal product with the OTC medicine or offer of any sample of the OTC medicine.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
In general, a medicine may be reclassified from a prescription-only medicine to a pharmacy-only medicine, or from a pharmacy-only medicine to a GSL medicine, if it has been deemed sufficiently safe for use with reduced or without medical supervision.
There are two mechanisms by which prescription-only medicines can be reclassified:
- firstly, the product registrant may submit an MAV-2 application to the HSA for reclassification of an already registered therapeutic product; and
- secondly, by legislative mechanisms, following a review by the HSA that a prescription-only medicine can be used in a safe and effective manner under the supervision of a pharmacist, subject to certain conditions or restrictions such as indication, strength, maximum daily dose, maximum supply quantity, and age restriction.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Subject to certain limited exceptions, an importer’s licence under the Health Products Act is required for the import of OTC medicines into Singapore, whereas an import licence under the Medicines Act is required for the import of traditional medicines into Singapore. For OTC medicines, additionally, the product will generally need to be registered with the HSA.