Understand the requirements to import, manufacture or sell medicated oils, balms and medicated plasters in Singapore.
Medicated oils, balms (MOB) and medicated plasters refer to any external medicated embrocation, medicated cream, ointment, inhalant or plaster which are mainly used for soothing purposes and may contain one or more of the following substances as active ingredients:
MOB exclude products that are used in aromatic diffusers and as fragrances. Medicated plasters exclude products that are used in wound dressings.
Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB for more information.
Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g. Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore.
You can also get a print-out of your product classification outcome from the tool.Let's go
Want to know more about CHP product classification? Click here for our FAQ.
Dealers may voluntarily notify HSA of their MOB and medicated plasters supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. Click here for more information.
MOB and medicated plasters are not subject to approvals and licensing by HSA for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in MOB and medicated plasters. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying MOB and medicated plasters into Singapore.
MOB and medicated plasters manufactured or imported and sold must not contain the following:
Your product must not exceed the following heavy metal limits:
Your product must not exceed the following microbial limits:
Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users. Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. The applicable guidelines is posted at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).
Your product needs to achieve acceptable standards of quality in terms of:
Please refer to the following guidelines for more information:
Your product label should be prominent and conspicuous. Its information in English should be adequate and truthful. The label should contain the following:
Please refer to the labelling standards guidelines288 KB for more information.
MOB and medicated plasters are to be used mainly for soothing purposes. Please note that you are also not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following conditions:
Dealers must ensure that all health claims and information associated with the products are sufficiently supported and submitted to HSA as and when required. Otherwise, all unsubstantiated health claims and information will be considered misleading and must be removed from the product materials. Please refer to the Guidelines for Claims and Claim substantiation325 KB, as well as the List of Health Claims259 KB for more information.
You will require a valid permit from us before publishing any medical advertisements or conducting any sales promotion activities directed to the general public.
Refer to our advertisements and promotions guidelines for more information on what is required before you run any advertisements and promotions for your products.
Use our guides below if you wish to apply for a GMP certificate or a CPP.
Some importing countries may require a certificate to show that the product is currently sold and distributed in Singapore.
As such, local exporters may apply for a FSC from the Health Sciences Authority.
Each FSC is specific to one product and allows the inclusion of up to five importing countries. Information in the FSC includes: