Current Consultations

Public consultations enable the HPRA to identify the needs and expectations of stakeholders so that we may incorporate their views into the way our services are planned and delivered.

Closed consultations

HPRA strategic plan 2021-2025

Consultation closing date: 3 January 2020

The HPRA has undertaken a public consultation on the HPRA Strategic Plan 2021-2025. The consultation period has now ended. A response document on the outcome of the consultation will be published in due course.

Guide to biosimilars for healthcare professionals  

Consultation closing date: 23 December 2019

The HPRA Guide to Biosimilars for Healthcare Professionals and Patients has been updated. The guide was originally published in 2015. Since then, there has been an increase in clinical and regulatory experience with this class of medicines as well as a growing body of scientific literature. The updated guide is now aimed solely at healthcare professionals, as the HPRA published a separate guide and information video for patients in 2017. The updated guide also provides further clarification of the HPRA’s position on interchangeability, switching and substitution.

The guide was open for public consultation to gather feedback from stakeholders as to whether it provided enough relevant information about biosimilars to meet their needs. The content of the guide has been amended to take account of the comments received as appropriate.

Outcome of the process

Guide to biosimilars for healthcare professionals v3 (5 August 2020)

Proposed human medicines, medical devices, veterinary medicines and compliance fees for 2020

Consultation closing date: 7 November 2019

The HPRA would like to thank everybody who contributed to the process. Below is a document summarising the outcome of the consultation process.

Outcome of the process