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 (for 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.