Minor variations to prescription medicines: Process guidance
Version 2.0, December 2017
This guidance is split into sections:
- Legislative basis for minor variations
- Including information about statutory timeframes and making an appeal
- Categories of minor variations
- Minor editorial changes (MECs)
- Self-assessable requests (SARs)
- Safety-related requests (SRRs)
- Category 3 requests
- Changes to the product information
- Variations to multi-component products
Separate guidance that sets out the individual variation change types for prescription medicines:
- Minor variations to prescription medicines - Appendix 1: Variation change types – chemical entities
- Minor variations to prescription medicines - Appendix 2: Variation change types – biological medicines
- Information on dossier requirements and how to submit your dossier to the TGA.
Other types of variations
Information about other types of variations to prescription medicines that are not minor variations is outlined in the Prescription Medicines Registration Process guidance.
Contact the TGA
Any questions regarding minor variations to prescription medicines should be directed to AET.firstname.lastname@example.org.