EUnetHTA 21 Public Consultation Guidance and Rules

General guidance and rules for public consultation of EUnetHTA 21 draft deliverables

  • Comments received from organisations outside EU/EEA countries are welcome but may not be considered by EUnetHTA 21 if this organisation is not directly impacted by the HTAR;

  • Organisations that review the deliverable during public consultation are requested to:
    • Take into account the corresponding project plan as well as the content of the EU HTAR when commenting. Comments that refer to matters out of the scope the deliverable or that are contradictory to the HTAR are not considered by EUnetHTA 21;
    • Depending on the topic and knowledge of details, reviewers should make concrete rewording suggestions and clearly explain the rationale behind them;
    • Please refrain from providing purely linguistic comments or flagging typos. If you provide editorial comments, please mark them as such in the comment form.

  • Comments must be received prior to the deadline and in the comment form provided by EUnetHTA 21. Comment forms must be submitted as a word-file. PDF files will not be accepted. No deadline extensions are possible. If comments are received after the deadline, or not within the correct format, they are not considered by EUnetHTA 21;

  • Only one consolidated comment form per organisation is accepted. If multiple forms are submitted on behalf of an organisation, EUnetHTA 21 considers the first document submitted. Therefore, EUnetHTA 21 strongly advises organisations to internally organise the responses to the public consultation. Additionally, if a comment form is received on behalf of the organisation as well as a different comment form from an individual, working at the same organisation, EUnetHTA 21 considers the comment form sent on behalf of the organisation. Should you as an individual submit a comment form based on a different function, and not on behalf of the organisation you work for, please make this very clear in the comment form. It is up to EUnetHTA 21 to decide if the comments received from the individual are eligible for consideration;

  • All comments received within the deadline of the consultation and following the correct format are published on the website, together with the final deliverable.
    • EUnetHTA 21 may decide to answer the eligible comments on an individual level, in a consolidated manner or by providing a written statement in general on the comments received. The answer(s) are made publicly available as well.
    • EUnetHTA 21 may decide to rank the comments received by importance.

  • Please note that it is not mandatory for EUnetHTA 21 to reflect all comments received in the draft deliverable. 

Deliverable  for public consultation

Start – End date

Status

D4.5 – Applicability of Evidence

04/07/2022 – 02/08/2022  

Public consultation is closed. 

D4.6 – Validity of clinical studies

04/07/2022 – 02/08/2022 

Public consultation is closed. 

D5.1 – Guidance JCA Submission Dossier Template

04/07/2022 – 02/08/2022  

Public consultation is closed. 

D7.1 HTD/HTA interaction

20/07/2022 – 19/08/2022

Available for public consultation

D4.3.1 Practical Guideline Direct and Indirect Comparisons

01/08/2022 – 30/08/2022

Available for public consultation

D5.2 Guidance JCA report template ​

01/08/2022 – 30/08/2022

Available for public consultation

D7.2 Guidance patient and HCP

01/08/2022 – 30/08/2022

Available for public consultation

(Please note that this deliverable consist of multiple documents)

D7.3 Template patient and HCP

01/08/2022 – 30/08/2022

Available for public consultation

(Please note that this deliverable consist of multiple documents)