To find out more about varying your ARTG entry please click on the links below.
More information
- Notifications process: registered 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 bioequivalence data, Appendix 2: Variation types - biological medicines
- Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data
- Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance
- Submitting applications for extension of indications to align with a reference product
- Annex 1: Examples of applications resulting in a new strength or a variation
- Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: chemical entities and biological medicines
- Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances
e-form
- Updates to variations to prescription medicines guidance and e-form
- Prescription medicines variation e-form: Frequently asked questions (FAQs)
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