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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance
Version 3.0, July 2019
This guidance describes how to make variations to existing entries for prescription medicines in the Australian Register of Therapeutic Goods (ARTG). The variations included in this guidance are quality and product information (PI) changes where evaluation of clinical and bio-equivalence data is not required. These applications are not lodged under the Prescription Medicines Registration Process.
See also:
- Separate guidance that sets out the individual variation change types for prescription medicines:
- Variations to prescription medicines excluding variations requiring evaluation of clinical or bioequivalence data - Appendix 1: Variation types - chemical entities
- Variations to prescription medicines excluding variations requiring evaluation of clinical or bio-equivalence data - Appendix 2: Variation types - biological medicines
- Information on dossier requirements and how to submit your dossier to the TGA.
Any questions regarding variations to prescription medicines should be directed to AET.application.entry.team@health.gov.au.
Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance
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Contents
- Introduction
- 1. Legislative basis for varying products
- 2. Variation category groups and categories
- 3. How to apply for a variation
- 4. Changes not submitted via the Variation e-form
- 5. Fees for variations
- 6. Processing and approvals