The Therapeutic Goods Administration (TGA) has detected fake semaglutide, also known as Ozempic, being illegally imported into Australia. The TGA recently tested two imported products labelled as semaglutide and found that they were counterfeit.
Laboratory testing confirmed that the following two products did not contain semaglutide as labelled:
- Global Health Pharmaceuticals and Therapeutics branded Semaglutide 5mg vial
- Peptides Lab branded Semaglutide 10mg vial.
These results serve as a warning to consumers to avoid buying semaglutide products from unverified online sellers, as they may not contain the active ingredient.
Counterfeit products may also contain other undeclared and hazardous ingredients that could cause serious risk to the health and safety of consumers. They also may not meet manufacturing quality and safety standards and have unknown contaminants.
Ozempic shortages
The recent worldwide shortage of semaglutide is being addressed, with limited supplies of Ozempic now being distributed in Australia.
The TGA, health professionals, pharmaceutical wholesalers, patient groups and Novo Nordisk are working together to manage the shortage and help patients. For more information visit the Ozempic shortage webpage.
No generic semaglutide alternatives available
Consumers should be wary of online offers for products claiming to be Ozempic or semaglutide, or any other hard to obtain products.
There are not currently any generic versions of this medicine being lawfully manufactured. This means that any product not manufactured by Novo Nordisk claiming to contain semaglutide is likely to be fake or counterfeit.
The manufacture of semaglutide is complex and requires specialised equipment. Currently, legitimate products are only manufactured by Novo Nordisk, who are the Australian sponsor of this prescription medicine, the sole manufacturer or Ozempic and Wegovy and the patent holder of semaglutide.
Generic medicines containing the same active ingredient can only be manufactured and sold by other companies once the patent for the existing brand has expired.
The TGA only monitors the safety of therapeutic goods that are registered for supply in Australia.
Sourcing semaglutide lawfully
Semaglutide (Ozempic, in Australia) is a schedule 4 prescription-only medicine, which can only legally be bought from a pharmacy using a valid prescription from a medical practitioner registered in Australia. Pharmacists may supply the Australian registered product, or an overseas substitute product approved by the TGA for temporary import and supply under section 19A of the Therapeutic Goods Act 1989 (Act).
It is illegal to import prescription-only medicines without a valid prescription, even if only for personal use. The Personal importation scheme usually allows for individuals with a valid prescription to import up to 3 months’ supply of medicines for personal use. However, it is important to be aware that counterfeit medicines cannot be imported under any circumstances.
In Australia, it is illegal to advertise prescription-only medicine to the public. This means that if you see advertising for Ozempic or semaglutide, it is illegal and likely represents a counterfeit product or a scam.
The TGA does not endorse any overseas websites advertised as supporting the Personal Importation Scheme – any websites that make this statement should be approached with extreme caution. Advertisers are prohibited from using a government logo or implying that any government body (including a foreign government agency) endorses a therapeutic good and must not use terms like 'TGA approved' in therapeutic goods advertising, including on labels or packaging. The use of a TGA logo or Commonwealth Coat of Arms is also prohibited.
Information for consumers
If you are taking imported products labelled as semaglutide from an overseas store or without a valid prescription, you should:
- stop taking the product immediately
- take any remaining product to your local pharmacy for safe disposal
- speak to your healthcare provider if you have concerns because of your use of this product.
The TGA recommends extreme caution when purchasing medicines from unknown overseas websites as they:
- may contain undisclosed and potentially harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
The TGA has approved the temporary supply of several overseas semaglutide products that are legal to purchase during the shortage. To check if your overseas product has been approved for temporary supply, visit the TGA Section 19A approvals database and search for ‘semaglutide’. These ‘section 19A’ products must be supplied through Australian pharmacies with a valid prescription.
Information for businesses
It is illegal to advertise prescription-only medicines to the public.
For those therapeutic goods that can be advertised to the public, advertising must comply with the advertising requirements set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code. Unregistered and counterfeit products can’t be advertised at all.
It is illegal to import counterfeit products into Australia.
Knowingly importing, selling and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.
The TGA continues to work with the Australian Border Force (ABF) to target counterfeit products entering Australia. The ABF will seize and destroy any counterfeit products intercepted at the Australian border.
The importation and supply of therapeutic goods must comply with legislation outlined in the Therapeutic Goods Act 1989. Generally, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported into Australia (unless they are exempt from the requirement to be entered in the ARTG) or approved under section 19A of the Act for temporary supply during a shortage.
Report counterfeit medicines and medical devices to TGA
Follow these links to report counterfeit medicines or medical devices or to report a problem or side effect from using them.
Report a suspected illegal importation or supply of counterfeit products to the TGA using the report a breach form.