New Version of the HPRA GDP Guide Published
Recommendation
10/11 September 2025
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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.
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