News Category: Regulatory news
The HPRA wishes to highlight that the European Commission has published an Implementing Regulation on good distribution practice for veterinary medicinal products. It will apply from 28 January 2022, in common with Regulation 2019/6, the New Veterinary Regulation.
The Regulation lays down measures on good distribution practice for veterinary medicinal products. It applies to manufacturing authorisation holders performing wholesale distribution and to holders of a wholesale distribution authorisation.
It covers the areas of quality management; personnel requirements; premises and equipment; documentation, procedures and record-keeping; operations; complaints, returns, recalls and suspected falsified veterinary medicines; outsourced activities; self-inspections and transport.
For more information, please see the text of the Implementing Regulation, which was published on 29 July 2021.