Ireland’s Health Products Regulatory Authority (HPRA) has updated two guidances, on good distribution practices (GDP) and wholesaling of medicinal products for human use.
The GDP guidance now includes a section on part-time responsible persons (RPs). HPRA will permit the use of part-time RPs provided they are continuously contactable, present at the site often enough to perform their duties and able to maintain oversight of their responsibilities when they are not present in person.
Furthermore, there is a new section explaining the effect of regulatory changes on the sourcing of exempt medicinal products.
In the updated wholesaling and brokering guidance, HPRA has added new regulations to the list of texts that provide the legislative basis for the advice:
- The safety features regulations
- Amendment to the obligations on holders of wholesaler’s authorisations
To view the revised GDP guidance, click here.
To view the updated wholesaling and brokering guidance, click here.