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.
Public consultation on proposed fees 2021: Human medicines, Compliance activities, Blood, Tissue establishments and Organs
Start Date of Consultation: 1st October 2020
Closing Date of Consultation: 30th October 2020
The HPRA wishes to seek comments on the annual review and proposal for fees 2021: Human Medicines, Compliance Activities, Blood, Tissue Establishments and Organs.
The HPRA is proposing no increase in fees for 2021 in recognition of the change in circumstances arising from COVID-19. The consultation identifies some minor clarification of fees arising from submissions or changing circumstances in the preceding 12 months.
Please send any comments or questions on these proposals by email to feesconsultation@hpra.ie.
Public consultation on human medicines fees 2021
A response document will be published providing a general overview of the comments received and the changes made to the proposals as a result.
The consultation complies with government policy on public consultation, as described in the document ‘Consultation Principles and Guidance’.
HPRA
1st October 2020
Public consultation on proposed medical devices fees 2021
Start Date of Consultation: 1st October 2020
Closing Date of Consultation: 30th October 2020
The HPRA wishes to seek comments on the annual review and proposal for fees 2021 –
Medical Devices.
The HPRA are proposing a general fee freeze for 2021 in recognition of the impact of COVID-19 in 2020. The HPRA are also proposing to amend a number of medical device fees to reflect new responsibilities under the MDR.
Please send any comments or questions on these proposals by email to
feesconsultation@hpra.ie.
Public consultation on medical device fees 2021
A response document will be published providing a general overview of the comments received and the changes made to the proposals as a result.
The consultation complies with government policy on public consultation, as described in the document '
Consultation Principles and Guidance’.
HPRA
1st October 2020
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)