Consultations

Consultation - Guide to Biosimilars for Healthcare Professionals  

Start date of consultation:        25 November 2019
Closing date of consultation:   23 December 2019


The HPRA Guide to Biosimilars for Healthcare Professionals and Patients has been updated. The guide was originally published in 2015 and since that time 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 HPRA welcomes comments on this updated guide and there is a consultation period of 4 weeks. All comments should be sent to biosimilarconsultation@hpra.ie. Please see below for links to clean and tracked changes versions of the proposed document.
 
Guide to Biosimilars for Healthcare Professionals v2.2
Guide to Biosimilars for Healthcare Professionals v2.2 (tracked changes)

HPRA
25 November 2019


Outcome of the Process - Public Consultation on proposed Human Medicines, Medical Devices, Veterinary Medicines and Compliance Fees for 2020

The public consultation on proposed human medicines and medical devices fees was closed on 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 - Public Consultation on Proposed Fees for 2020

HPRA
28 November 2019


Outcome of Process - Public consultation on Annual Review and Proposal for Fees for 2019

The HPRA sought comments on the Annual Review and Proposal for Fees 2019.

Please see: Outcome of the Process - Public Consultation on proposed Human and Veterinary Medicines and Compliance Fees for 2019

The consultation was in compliance with government policy on public consultation, as described in the document Reaching out: Guidelines on Consultation for Public Sector Bodies.


Outcome to public consultation on proposed Human and Veterinary Medicines and Compliance Fees for 2018

The public consultation on the annual review and proposal for fees 2018 was closed on 31st October 2017

The HPRA would like to thank everybody who contributed to the process. 

Please see: Outcome of the Process - Public Consultation on proposed Human and Veterinary Medicines and Compliance Fees for 2018


Guide to Biosimilars for Healthcare Professionals and Patients (2015)

The public consultation on the Guide to Biosimilars for Healthcare Professionals and Patients was closed on 22 May 2015. Inputs to this consultation continued to be received and were accepted after this date. The HPRA would like to thank everybody who contributed to the process. Below is a document summarising the outcome of the consultation process.

The guide is intended to provide information on the regulation, prescribing, dispensability and traceability of biosimilar medicines in Ireland. The guide is targeted primarily at healthcare professionals but is also relevant to patients, manufacturers, distributors and those involved in hospital procurement.

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.

Response Document - Public Consultation on Guide to Biosimilars for Healthcare Professionals and Patients
 

Guide to Biosimilars for Healthcare Professionals and Patients


Human medicines fees consultation 2016.

The public consultation on the annual review and proposal for fees 2016 was closed on 30 October 2015.

The HPRA would like to thank everybody who contributed to the process.
Please find below a response document providing a general overview of the comments received and the changes made to the proposals as a result.

Outcome of the Process - Public Consultation on Proposed Fees for 2016

This consultation was in compliance with government policy on public consultation, as described in the document Reaching out: Guidelines on Consultation for Public Sector Bodies.