Stakeholder consultation – Registration of processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the Clinical Trials Regulation

We have published a consultation document relating to the registration of processes exempted under Article 61 (5) and applicable requirements under Article 61 (6) of the Clinical Trials Regulation. We are seeking feedback from stakeholders on these items:

• A draft ‘Questions and Answers’ document on Article 61 (5) processes of the Clinical Trials Regulation;
• Our proposal to refer to the ‘PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments’ as the core guidance for the appropriate and proportionate requirements for the exempted processes.

Full information: Consultation document

Start date of consultation: 30 May 2022

Closing date of consultation: 22 August 2022

Replies are welcome from all stakeholders. Please send any comments or questions by email to article61.5@hpra.ie

A response document will be published providing a general overview of the comments received and the changes made to the proposals as a result.

This consultation complies with government policy on public consultation, as described in the document Consultation Principles and Guidance.