Overview
In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality. Depending on the vitamin and the dose, vitamins are regulated either as prescription medicines or complementary medicines. Most vitamins fall into the category of low-risk complementary medicines. Unless exempt in the Therapeutic Goods Act of 1989, medicines sold in Australia must be included in the Australian Register of Therapeutic Goods (ARTG).
TGA’s Pre-Market criteria of vitamins:
The TGA’s pre-market assessment of complementary vitamins and other low-risk medicines involves products meeting specific criteria:
- The product must only contain ingredients from a pre-approved list that the TGA has already assessed for safety and quality.
- The commercial sponsor of the product must choose from a pre-approved list of uses, and these uses can only relate to minor health problems. Products are prohibited from making claims about serious and life-threatening conditions.
- The product must be manufactured in a certified facility that meets quality standards.
- The sponsor of the product must hold evidence that their product does what they say it does.
Good Manufacturing Practice:
All medicines, unless exempt, must be manufactured under the principles of GMP
- Australian manufacturers must hold a GMP licence
- Overseas manufacturers must hold GMP clearance certificate
Check the List of Permitted Ingredients:
A list of all low risk ingredients that have been pre- approved by the TGA are Included in the Permissible Ingredients Determination.
Ingredients may have restrictions, such as:
- concentration limits
- route of administration
- plant parts
- type of preparation
- container type
- warning statements
Check the list of Permitted Indications:
An exhaustive list of all permitted indications and their requirements are contained in the Permissible Indications Determination No 1 of 2018 . The list of permitted indications will classify the category of the complementary medicine.
For example, Listed medicines are can only refer to low level indications such as;
- health enhancement
- health maintenance
- prevention of dietary deficiency
- a disease, ailment, defect or injury other than a serious form of those diseases
Register your Product on the ARTG:
All medicines that are approved for supply by the TGA include either an AUST R number or an AUST L number on their label.
- Higher risk medicines are registered in the ARTG as AUST R. AUST R numbers are for registered medicines that the TGA has evaluated for safety, quality and efficacy.
- Lower risk medicines are listed in the ARTG as either AUST L or AUST L(A). AUST L numbers are for low-risk listed medicines, such as most vitamin products, that the TGA regulates for safety and quality only.
Medicines that do not display these numbers may not be approved for sale in Australia. This is especially a concern for products sold online, which may contain unlisted, potentially dangerous ingredients.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.. To learn more, please contact us at info@globalregulatorypartners.com