New applications – medicines for human use
Licensing procedures
A company can choose one of three ways to apply for authorisation of a new product.
Learn more
Generic and interchangeable medicines
Download a guide explaining how the interchangeables list is prepared.
Learn more
Legal supply status and reclassification
Apply for reclassification of a medicine's prescription or supply status
Learn more
Drug-device consultations
Process and requirements for submitting consultations to the HPRA
Learn more
Electronic submissions
The HPRA only accepts electronic submissions. See our guide for details.
Learn more