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 the proposal for Clinical Trials fees 2022

Start Date of Consultation: 10th September 2021
Closing Date of Consultation: 8th October 2021

The HPRA and the newly formed National Office for Research Ethics Committees (hereafter ‘the National Office’; www.nrecoffice.ie), wish to seek comments on the review and proposal for fees for 2022, under the new Clinical Trial Regulations.

The HPRA and NREC are proposing to increase/restructure a number of clinical trial fees to reflect new responsibilities under the new legislation.

Please send any comments or questions on these proposals by email to feesconsultation@hpra.ie.

Public Consultation on Clinical Trial Fees 2022

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
10th September 2021

Closed consultations

Below are public consultations that have recently closed. Please see here for older consultations.

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 public consultation on proposed fees for Human Medicines, Compliance Activities, Blood, Tissue Establishments and Organs for 2021 was closed on 30 October 2020. 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 - Public Consultation on Proposed Fees for 2021
 
Public consultation on human medicines fees 2021

HPRA
04 December 2020
 

Public consultation on proposed medical devices fees 2021 

Start Date of Consultation: 1st October 2020
Closing Date of Consultation: 30th October 2020

The public consultation on proposed fees for medical devices for 2021 was closed on 30 October 2020. The HPRA would like to thank everybody who contributed to the process. Below is a document summarising the outcome of the consultation process.

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)