New Version of the HPRA GDP Guide Published

The Irish Health Products Regulatory Authority (HPRA) has released an updated version of its Guide to Good Distribution Practice of Medicinal Products for Human Use. Version 8 (document IA-G0046-8) was published in April.

The guide is intended to provide additional clarification to wholesalers and brokers located in Ireland regarding the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use - 2013/C 343/01).

A tracked-changes version of the document shows that, in addition to minor editorial edits, updates and additions have been made to the following sections:

• Supplier approval
• Sourcing of exempt medicinal products
• Verification of safety features
• Establishment of the authority of customers to receive medicinal products
• Decommissioning of unique identifiers prior to supply

The updated guide is available for download as a PDF file.