Approach to quality standards and R&D

The TGA released TGO 110 in May 2021, which sets a series of minimum standards for NVPs intended for domestic distribution in Australia. While the standards set in TGO 110 address a number of the quality aspects of NVPs, it may not fully address the quality and safety concerns of doctors and pharmacists, by providing comfort that compliant NVPs are appropriate for prescription in the manner expected of other medicines and therapeutic goods.

The issue of assessing which NVPs are appropriate in a medical framework is compounded by the lack of precedent in other markets that would allow doctors and pharmacists comfort that products are manufactured appropriately.

The lack of another medical framework has two key implications for assessing stakeholders in Australia:

• It is difficult to know how to assess NVPs; and
• There can be no presumption that NVPs from other markets have been manufactured to standards that are appropriate for medical prescription.

By applying a series of existing, internationally recognised standards, testing protocols and processes, in addition to meeting the requirements of TGO 110, the Nicovape® Q cartridge system sets the quality standard for NVPs, providing assurance around the quality and safety aspects of the product and establishes the baseline from which to establish efficacy and increase safety in the long-term.

Liber has developed its standards framework in a manner that will allow GPs and pharmacists a standardised checklist of minimum standards when assessing the appropriateness of an NVP. In Liber’s view, this framework sets out a series of independent certifications and manufacturing and legal safeguards with which all NVPs prescribed in Australia should conform.

See our product standards for detailed information about the quality and safety aspects of the Nicovape® Q.