Wholesale Distribution of Medicines

Wholesale distribution of medicines for human use includes the following activities;

• Procurement (purchase) of medicines for human use.
• Holding (storage) of medicinal products for human use.
• Supply (sale within the EEA) of medicinal products for human use, apart from to the public.
• Export (sale to outside the EEA) of medicinal products for human use, apart from to the public.

Note: Brokering of medicines is different to wholesaling, as it does not involve owning or physically handling medicines. It involves:

• Negotiation for procurement (purchase) or supply (sale) of medicines.
• Acting independently and on behalf of another legal or natural person.

You can find further information on our Brokering of medicinal products page.

Who regulates wholesalers of medicines in Ireland

The regulation of wholesalers of medicines for human use

• Wholesalers must apply for an authorisation from the HPRA before they can perform any wholesale activities in Ireland. You can find a list of authorised wholesalers of medicines on the EudraGMDP website.
• The wholesaler must comply with Good Distribution Practice (GDP) Guidelines and EU and national legislation.
• The HPRA inspects wholesalers to ensure compliance with GDP and relevant legislation, both before an authorisation is granted and routinely thereafter.
• Once authorised, a wholesaler must submit a variation application if it wishes to make certain changes to its activities.

Essential guidance for wholesaling in Ireland

You can find guidance for wholesaling in Ireland in the links and documents below.

• The European Commission's Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
  

Special topics

• Exempt medicinal products.
• Controlled Drugs.