Brokering of medicines

What is brokering of medicines?

Brokering of medicines for human use is:

• Negotiation for procurement (purchase) or supply (sale) of medicines for human use.
• Acting independently and on behalf of another legal or natural person.
• Never involves owning or having the medicine in their possession.

What is a broker?

The term 'broker' refers to a person or company that is involved in the brokering of medicines for human use.

What are the differences between brokering and wholesale distribution?

There are two key differences between brokering and wholesale distribution: activity and ownership

Activity

• Brokering is the activity of negotiation for procurement (purchase) or supply (sale) of medicines for human use.
• Wholesale distribution is the activity of procurement (purchase), holding, supply (sale) or export of medicines for human use apart from to the public.

Ownership

• Brokers act independently and on behalf of another legal or natural person. They will never own or physically handle the product.
• Wholesalers and distributors act for themselves. They will own or physically handle the product at some point in time.

Is a company considered a broker if they purchase and sell medicinal products for human use without ever physically handling the product?

No. The company is acting for themselves. They will own the product at some point in time even if they never physically handle the product. This is considered wholesale distribution and the company must hold a wholesale authorisation (WDA) for these wholesaling activities.

What are the requirements for a broker operating in Ireland?

Brokers located in Ireland must:

1. Register with the HPRA.
2. Comply with the relevant principles of Good Distribution Practice (GDP) (See GDP Guidelines 2013/C 343/01 below).

It is advisable that a broker reads and understands the EU and HPRA guidance relating to brokering in Ireland. Please find links to these guidance documents below. 

• The European Commission's Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
• Directive on the Community code relating to medicinal products for human use (2001/83/EC as amended).
• S.I. No. 164/2013 Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013.
  

What does my company need to do as an authorised wholesaler interested in using the services of a broker?

Authorised wholesalers interested in using the services of a broker must:

1. Confirm that the proposed broker is registered with the regulator of the country in which they are located (See 'Broker Approved List' for the list of registered brokers in Ireland).
2. Verify that the broker complies with the relevant principles of Good Distribution Practice (GDP).
   

Further Information

You can find a list of registered brokers in Ireland on our List of registered brokers page.

Any further queries regarding brokers can be sent to the HPRA's Compliance department. Please see the Contact Us page for details.