Guide to reporting of quality defects
30 October 2012
This guide covers the reporting to the Irish Medicines Board (IMB) of potential quality defects involving the following categories of medicinal products for human and veterinary use:
- Medicinal products which are the subject of a marketing authorisation (MA) or a registration for the Irish market,
- Medicinal products manufactured in Ireland for distribution outside of Ireland,
- 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,
- Exempt medicinal products for human use which are supplied to the order of a registered doctor or a registered dentist for use by his/her individual patients under his/her direct personal responsibility, or in the case of unauthorised veterinary medicinal products, supplied in accordance with the cascade system,
- 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.
This is an industry guide for the following stakeholder groups:
- Marketing authorisation holders (MAHs)
- Registration holders
- Clinical trial sponsors
This guide does not cover products regulated under the Biocidal Products Directive or Medicated Feeding Stuffs Directive.
Guide to reporting of quality defects in medicinal products for human and veterinary use v2
This guideline was first published in September 2010 and has been used since then by industry to determine if a quality defect is required to be reported to the IMB. After two years of use, a review of feedback from industry and the experience of IMB staff has led to the revision of the guideline.
The guideline has a number of changes, the most significant of which are listed below:
- Now includes a reference to the expectations of the IMB in relation to reporting of defects by active substance manufacturers
- Provides additional guidance on the initial investigation upon receipt of a quality defect report
- Includes the expectations of the IMB regarding the implementation timelines of variations
- The criteria for not reporting defects has been updated to include certain quality defects that are classified as major defects
- An appendix has been added to include a guide on the information required (or as much of it as is available) by the IMB when submitting a quality defect report.
See the version with changes tracked for details.
Guide to reporting of quality defects in medicinal products for human and veterinary use v2 changes tracked