In the ever-evolving pharmaceutical landscape, staying compliant means staying informed. Regulatory bodies are continuously updating guidance to reflect changes in technology, risk, and industry best practice, and Ireland’s Health Products Regulatory Authority (HPRA) is no exception.
Over the first half of 2025, the HPRA has rolled out several key updates that directly impact Good Distribution Practice (GDP), advertising compliance, and product safety. For companies operating in or exporting to the Irish market, these updates carry both operational and compliance implications.
At Orion GxP Consulting, we’ve summarised the most important changes below, along with insights on how your organisation can stay ahead of the curve.
GDP Guide Version 8 – April 2025
The HPRA’s “Guide to Good Distribution Practice of Medicinal Products for Human Use” (IA-G0046-8) has been updated to Version 8. This new edition reinforces the need for robust supplier qualification and tightens expectations around the supply chain.
Key changes include:
Enhanced supplier approval protocols
Revised guidance for sourcing exempt medicinal products
Expanded expectations around safety feature verification
Additional details on verifying customer authority to receive medicinal products
Clarity on decommissioning unique identifiers prior to supply
What this means for you:
Distributors must revisit SOPs, contracts, and audit programs to align with the revised expectations. Supply chain visibility and traceability are no longer optional—they’re essential.
Advertising Compliance – March 2025 Update
The HPRA has also released a revised Advertising Guidance document, developed in collaboration with Ireland’s media regulator, Coimisiún na Meán.
Notable revisions include:
Stricter guidance on digital advertising and promotional websites
Defined scope for non-promotional patient materials
Requirements for abbreviated prescribing information in healthcare-targeted ads
Reclassification of some healthcare professionals (e.g., allied health) as the general public under the ad regulations
Clarified distinction between promotional and non-promotional presentations
Implication:
Marketing teams and compliance leads must carefully review current materials and digital campaigns. What qualified as “educational” yesterday may now be considered promotional. Cross-functional review between regulatory, medical, and marketing is essential.
Updated Human Medicines Guidance – Spring/Summer 2025
In addition to GDP and advertising, the HPRA released multiple revised guidance documents this year, including:
Guide to parallel imports (June 2025)
Guide to registration under Article 61(5) CTR (May 2025)
Updated advertising guide (March 2025)
GDP guide, version 8 (April 2025)
Action Point:
Regulatory Affairs and Quality teams should ensure internal references and documentation reflect the most current guidance versions. Submissions or inspections referencing outdated versions could raise red flags.
Drug Safety Newsletter – Issue 119 (June 2025)
The HPRA continues to flag critical pharmacovigilance updates. Recent issues highlight important new safety data:
Finasteride / Dutasteride: EU-wide review indicates potential for suicidal ideation
Bilastine: Added warning for QT prolongation and torsades de pointes risk
Azathioprine: Stronger guidance on hepatotoxicity and monitoring
Mesalazine: Alert on idiopathic intracranial hypertension
Next Steps:
Pharmacovigilance systems should reflect these updates immediately. Labelling, risk minimisation materials, and safety communication plans may require updating.
Fraudulent Advertising Alert – May 2025
The HPRA issued a public warning following a rise in fraudulent online advertisements, especially involving illegal medicines falsely branded with HPRA logos.
Why it matters:
If your brand or authorised product is being misused, you must report it. Companies should also monitor digital platforms and work with partners like Shopify and Meta to protect brand integrity and patient safety.
Final Thoughts: Compliance as a Strategic Advantage
These updates underscore a broader trend: regulators are adapting quickly to changes in technology, communication, and supply chains. Your organisation’s ability to respond—efficiently and accurately—can set you apart.
At Orion GxP Consulting, we help our clients turn regulatory complexity into competitive advantage. Whether you need support updating SOPs in response to GDP v8, auditing promotional materials, or adapting pharmacovigilance systems, our expert team is here to help.
Contact us today to ensure your compliance strategies are aligned with the latest expectations.