2San is a leading global distributor of high-quality COVID rapid antigen tests (RATs) and works with regulators around the world to ensure compliance with local standards.
2San have been in contact over several months – in writing and via phone – regarding some extra information the Australian Therapeutic Goods Administration was requesting.
On 10 August 2022, 2San was issued with infringement notices in relation to the provision of the information. We had been working on the understanding that the information was needed by 12 August 2022.
These non-compliance notices relate to technical breaches regarding the provision of information to the TGA, not to the quality of our products.
2San has been in contact with the TGA both in writing and on the phone since the infringement notice was published on its website yesterday, with a view to resolving this matter as soon as possible.
As of the 11 August 2022, 2San believes it has now fully complied with the provision to the TGA of the requested information.
We agree with the TGA that companies need to take compliance obligations seriously, and further add that engagement between the regulator and the sector needs to be fair at all times.
We have initiated proceedings with the TGA to have the infringement notices withdrawn and look forward to having this issue resolved as efficiently as possible.