Did you know that the HPRA updated their Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland (IA-G0008-8) last week?
This is a key document for all wholesalers and brokers in Ireland to be aware of.
The main updates are to the reflect recent change to the HPRA website. As part of the HPRA’s new website re-design, they have also removed the list of wholesalers and their compliance status which was previously a useful tool that our RPs used as part of their supplier/customer qualification processes.
Whilst there were minimal updates to the text version of the Guide, the previous revision was issued back in March 2022 so it is always good to refresh your memory on the HPRAs guidance when it comes to wholesale and brokering.
Some reminders from these guidelines include:
- Definition of wholesaling according to HPRA:
- Procurement: Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors
- Hold – Storing medicinal product
- Supply – All activities of providing, selling, donating medicinal product to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the public
- Export – Allow Community goods to leave the customs territory of the Union. For the purposes of these guidelines, the supply of medicines from an EU Member State to a contracting State of the European Economic Area is not considered as export. ** remember this also includes UK**
- Physical and Financial transactions
While it is important to understand the physical flow of the product, the financial movement of the product is just as important and must be fully traceable back to the WDA holder. As operations are becoming more and more complex and the increased number of virtual WDAs across Europe, sometimes the financial transactions can be overlooked. It is important to remember that any company involved in buying and selling medicinal products must obtain a WDA. Every WDA holder must qualify and approve the physical and financial supplier of products under the scope of their WDA.
Logistics Providers requiring a WDA
In most cases, logistics service providers transporting products do not require a WDA unless they will hold the product at their site for longer than 48 hours. However, if the logistics service provider holds cold chain products for any amount of time, a WDA is required.
Brokering:
The HPRA define brokering as “all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution and sale by wholesale, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.”
All brokers operating in Ireland must register with the HPRA and be approved before they start any brokering activities. Following the application to the HPRA, the HPRA can inspect the brokering site to ensure compliance with the Falsified Medicines Directive 2011/62/EU and EU GDP Guidelines 2013/C 34301/. If the HPRA are satisfied that the site is compliant, the site will be added to the HPRA’s brokers’ register which can be accessed on the HPRA’s website – List of registered brokers
If you would like to speak to one of RPs regarding this update or general wholesaling/brokering queries, please get in contact with enquiries@acornregulatory.com
