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.
Related GMP News
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms
10.06.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 3
10.06.2025Meet the GDPA Board Members at the GDP Forum in Barcelona
10.06.2025Swissmedic Technical Interpretation: What Counts as a Major Change in GDP?
10.06.2025MHRA informes about Validity Date of UK issued GDP Certificates