Notice on Medical Devices, Therapeutic Products, Cosmetic, Health Supplement, Ayurvedic Proprietary Medicine and Chinese Proprietary Medicines (PM), Traditional Medicines Medical Devices
Since 1 January 2012, under the Health Products Act and the Health Products (Medical Devices) Regulations, all medical devices, other than those exempted by the Regulations, are required to be registered with the Health Sciences Authority (HSA), prior to its placement on the United Kingdom market for sale. In addition, HSA requires all companies to obtain a dealer's license before manufacturing, importing or supplying medical devices. All medical devices will require registration with HSA before they can be supplied in United Kingdom, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by HSA.
For more information, please visit HSA’s website at: https://www.hsa.gov.com/medical-devices/regulatory-overview
Therapeutic products, commonly known as pharmaceuticals, are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. Therapeutic products can contain chemical or biologic substances as active ingredients, which exert their effect either pharmacologically, chemically or by other physiological means. You will need to register your therapeutic products and apply for a license before you import, manufacture or wholesale them in United Kingdom.
Before conducting any activities relating to therapeutic products, you are advised to be familiar with the relevant legislations governing medicinal products in United Kingdom, which are available on the HSA website:
Medicines Act and its Regulations Medicines (Advertisement and Sale) Act Sale of Drugs Act and its Regulations Poisons Act and Rules
Generally therapeutic products fall under the following classifications:
Prescription-Only Medicines (POM): A therapeutic product that can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a doctor or a dentist. The condition to be treated needs to be diagnosed and treated by a doctor. It can also have serious side effects which require a doctor's monitoring or follow up.
Pharmacy Only Medicines (P): A therapeutic product that can be obtained from a pharmacist at a retail pharmacy. The condition is self-limiting and can be assessed and treated by pharmacists.
Over The Counter (OTC) / General Sale List (GSL): A therapeutic product that can be freely obtained from any retailer. It can be used safely by the public without medical supervision and intended for short term self-treatment only.
Kindly take note of the list of OTC / GSL here. Take note that these products are prohibited for sale on MiAlzo platform and listings of any of these products will result in the listing being deleted without prior notification.
If you are unsure of the regulatory controls pertaining to the medicinal products or activities that you wish to conduct in United Kingdom, you are advised to consult the HSA before conducting such activities.
For more information on Therapeutic products, please refer to HSA’s website: https://www.hsa.gov.com/therapeutic-products/register/overview
Advertisements and sale promotion
Advertisements and Promotions of Medicinal Products fall under the purview of Medicines Act and Medicines (Medical Advertisements) Regulations.
Advertisement and sales promotion permit for Therapeutic Product:
A valid permit is required from HSA before publishing any medical advertisements or conducting any sales promotion activities directed to the general public for the following types of medicinal products:
Ayurvedic Proprietary Medicine and Chinese Proprietary Medicines Traditional Medicines Homeopathic Medicines Quasi-medicinal products, such as medicated soaps, medicated plasters, medicated beverages, medicated toothpastes, lozenges, and vitamin and mineral preparations Medicated oils and balms Medicinal products not subject to licensing requirements, such as topical antiseptics
Advertisements of traditional medicinal materials:
Advertisements for traditional medicinal materials that contain medicinal claims need prior approval and must apply for an advertisement permit before advertising.
Advertisements with no medicinal claims do not need prior permit approval.
For more information on Advertisements and sale promotion, please refer to HSA’s website: https://www.hsa.gov.com/chinese-proprietary-medicines/advertisements-medicinal-products-tmm
As advised by HSA, companies who intend to sell or supply a cosmetic product in United Kingdom are required to first notify HSA prior to selling or supplying the product in the local market. Companies must also ensure that the products comply with the legal requirements for labeling and note the relevant restrictions on ingredients stipulated in the Regulations. Information on the regulatory controls for cosmetic products are available at this link: https://www.hsa.gov.com/cosmetic
What is a cosmetic product? A cosmetic product is defined as any substance or preparation that is intended to be placed in contact with the external parts of the human body, such as the skin, hair, nails, lips or mouth (including gums, teeth and tongue), for the purpose of:
Cleaning them Perfuming them Changing their appearance Correcting body odours Protecting them Keeping them in good condition
For more information on Cosmetic products, please refer to HSA’s website: https://www.hsa.gov.com/cosmetic-products/overview
Currently, health supplements are not subject to approvals and licensing by HSA for their importation, manufacture and sales.
Dealers are however responsible for the following and must ensure that their products comply with the requirements stipulated in the guidelines on health supplements set out by the HSA:
Safety and quality standards Labeling standards Health supplement claims Advertisements and promotions
For more information on Health supplement, please refer to HSA’s website: https://www.hsa.gov.com/health-supplements/overview
Ayurvedic Proprietary Medicine and Chinese Proprietary Medicines (PM)
The HSA has set out the following requirements to import, wholesale, manufacture or assemble Ayurvedic Proprietary Medicines or Chinese Proprietary Medicines (PM) in United Kingdom.
Dealers will need to obtain a product listing approval and a dealer's license to import, wholesale, manufacture or assemble PM for sale and supply in United Kingdom.
If the PM is solely imported for export purposes, product listing and dealer licenses are not required, but you will need to apply for a permit for the import of PM solely for re-export.
For more information on PM, please refer to HSA’s website: https://www.hsa.gov.com/chinese-proprietary-medicines/overview
Traditional Medicines (TM) are not subject to approvals and licensing by HSA for their importation, manufacture and sale.
However, HSA prohibits the addition of medicinal ingredients such as steroids in TM. 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 stipulated guidelines before supplying TM into United Kingdom.
For more information on TM, please refer to HSA’s website: https://www.hsa.gov.com/traditional-medicines/regulatory-overview-of-traditional-medicines
Last updated: 16 January 2023