The requirement for brokers and wholesalers in Ireland to comply with the guidelines of GDP is laid down in Articles 80(g) and 85(b) of Directive 2001/83/EC and Schedule 2, Paragraph 13 of …
New Version of the HPRA GDP Guide Published
May 13, 2025 · 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. …
Ireland HPRA’s Guide: Good Distribution Practice (GDP) of …
May 3, 2025 · This updated guide, "Good Distribution Practice of Medicinal Products for Human Use" on 8th April 2025 outlines how companies should store, transport, and distribute …
GDP inspections - hpra.ie
Find out about the process for HPRA inspections, the different types of inspections, as well as the types of deficiencies that can be identified.
Good distribution practice | European Medicines Agency (EMA)
EMA maintains a compilation of GDP and GMP inspection-related procedures and forms agreed by all Member States. This facilitates cooperation between EU Member States and supports …
Regulatory guidance documents for products we regulate - HPRA
Guidance documents provide information about complying with regulatory procedures. Select a product area from the dropdown list.
Staying Ahead of the Curve: Key HPRA Guideline Updates …
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 …
New Version of the HPRA GDP Guide Published - ECA Academy
May 13, 2025 · 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.
The full text of the guidelines is available on the European Commission website: Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use.
These guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.