Mandatory requirements for an effective registered complementary medicine application
This document describes the information (and the form of that information) that must be submitted to the TGA in order for an application to register a complementary medicine to be considered effective and proceed to evaluation.
These requirements apply to applications to register a complementary medicine that are lodged with the TGA from March 2018, including applications to change a registered complementary medicine (RCM) that results in a separate and distinct good under subsection 16(1) of the Therapeutic Goods Act 1989 (the Act) to which the Therapeutic Goods (Groups) Order No. 1 of 2001 applies.
Applications for new registrations
- are made in accordance with a form or in a manner approved by the Secretary (subsection 23(1) of the Act)
- include such information in a form approved by the Secretary as will allow the determination of the application (paragraph 23(2)(b) of the Act); and
- for restricted medicines, include product information in the form approved under section 7D of the Act (paragraph 23(2)(ba) of the Act).
Section 23 instruments
The Section 23 instruments specify how applications to register a complementary medicine must be made and require applications to include the information described in the following regulatory documents in order to be effective and proceed to evaluation:
- Mandatory requirements for an effective registered complementary medicine application (this document)
- CTD Module 1: registered complementary medicines.
Registered complementary medicine applications
For information on the RCM application levels that are referred to in this document, and the application process, go to:
- An overview of the regulation of complementary medicines in Australia
- Complementary medicine registration process
- Determining the correct application level for RCM medicine submissions (Application Categories RCM1 to RCM5)
- Process to change a registered complementary medicine (CN to C4)
- Complementary medicines changes tables
- Mandatory requirements for an effective application (this document)
- A new registration is one that requires a new ARTG entry by reason of being separate and distinct goods under section 16 of the Therapeutic Goods Act 1989. This includes new chemical entities, new strengths, new dosage forms, different directions for use, formulation changes, changes in trade name, extension of indication etc. Under the Therapeutic Goods (Groups) Order No. 1 of 2001, not all new registrations will result in a new AUST R number being allocated if the existing medicine is 'grouped' with the new medicine.