Submitting applications for extension of indications to align with a reference product

Applications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.

For further information see:

• Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data; Appendix 1: Variation types - chemical entities.
• Extension of indications to align with a reference product in Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data; Process guidance.