Review and appeal rights for ingredient applicants

3 July 2017

The TGA has amended the Therapeutic Goods Act 1989 (the Act) to provide review and appeal rights for persons who apply to have a new ingredient permitted for use in listed complementary medicines.

The legislative amendments implement Recommendation 47 of the Medicines and Medical Devices Review (MMDR). Implementation of this reform increases transparency of TGA administrative processes, improves procedural fairness and removes barriers to business.

Background

Listed medicines can only contain certain low risk ingredients in acceptable amounts that are approved by the TGA. The ingredients available for use in listed medicines and requirements associated with their use are specified in the Permissible Ingredients Determination. If a person wishes to use an ingredient that is not currently included in the permitted ingredients list, they must apply to have the ingredient evaluated by the TGA before its use is permitted.

Previously, review and appeal rights were not available in relation to TGA decisions about applications for new ingredients, such as where the TGA refused to approve the use of the ingredient in listed medicines.

What has changed?

From July 2017, persons who apply to have a new ingredient permitted for use in listed complementary medicines can appeal the TGA's decision about that application under section 60 of the Act. These rights are similar to those already in place for decisions about applications for registration and listing, however they will only be available to the person who made the application and only in relation to decisions to refuse to permit the use of the ingredient in listed medicines.

The application and evaluation processes for new ingredients will not change.

Further information

For more information about review and appeal rights for decisions under the Act, please refer to 'Guidance for requesting reconsideration of an initial decision'.

If you have specific questions regarding an application you have lodged for assessment, please contact Complementary Medicines via phone on 1800 020 653 or via email at .