Product standards

The TGA, and similar regulatory bodies around the world, set rigorous standards for the therapeutic products and medical devices that doctors and patients rely upon for peace-of-mind and quality assurance.

These standards ensure a minimum level of conformance with such things as:

• Product safety and design;

• Certified ingredients / prohibited ingredients;

• Certified manufacturing facilities and cleanroom environments;

• Appropriate packaging and labelling requirements; and

• Agreed emissions standards.

As such, it would be prudent to require a similar set of standards to be met by NVPs intended to be prescribed by Australian doctors.