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Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA

On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use".

A quality defect in a medicinal product may be defined as an attribute of a medicinal product or component which may affect the quality, safety, and/or efficacy of the product, and/or which is not in line with the approved product authorisation (PA) or veterinary product authorisation (VPA) file, or other marketing authorisation.

The purpose of the guidance is to ensure that stakeholders are better equipped to report and investigate quality defects. The overall aims are:

(i) To ensure that potential quality defects are investigated and reported appropriately and in the required timeframes, to reduce, remediate or remove risk to patients or animals

(ii) To ensure that the requisite oversight is applied to defect issues, commensurate with the level of risk posed to patients or animals

This is an industry guide for the following stakeholder groups:

  • Marketing authorisation holders (MAHs)

  • Registration holders

  • Clinical trial sponsors

  • Manufacturers

  • Wholesalers

This guide covers the reporting to the Health Products Regulatory Authority (HPRA) of potential quality defects involving the following categories of medicinal products for human and veterinary use: -

  • medicinal products which are the subject of marketing authorisation (MA) or a registration for the Irish market

  • medicinal products manufactured in Ireland for distribution outside of Ireland

  • medicinal products manufactured in Ireland for distribution to Ireland, but which do not possess an MA (compounded products)

  • medicinal products which are neither authorised nor manufactured in Ireland, but which are distributed outside of Ireland by Irish wholesalers or manufacturers

  • promotional samples of medicinal products that are either manufactured in Ireland and/or are issued to Irish healthcare professionals

  • investigational medicinal products manufactured and/or distributed in Ireland for the purposes of performing clinical trials

  • active substances used in the manufacture of medicinal products

Check the guide for more updates and detailed information.

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