Guide to reporting of quality defects
25 March 2014
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 v3
The guideline has recently been revised to update the contact details.
See the version with changes tracked for details.
Guide to reporting of quality defects in medicinal products for human and veterinary use v3 changes tracked