Broker Approved List
The contents of the registry is believed to be correct at the time of compilation. It is important to note that this information may be updated several times within a month. While every effort is made to ensure the accuracy of the information, it is not possible to guarantee that it is complete, accurate and up-to-date. If errors are brought to our attention, we will investigate them immediately. The list have been made available for information purposes only.
Broker Approved List 21.12.2018
Information for Brokers What is a broker?
The term 'broker' as introduced by the Falsified Medicines Directive, refers to a person or company that is involved in the brokering of medicinal products for human use. What is meant by the term 'brokering of human products for human use'?
Brokering of medicinal products for human use means all activities in relation to the procurement (purchase) or supply (sale) of medicinal products for human use, except for wholesale distribution and sale by wholesale.
In other words, a company brokering a product never physically handles the product and never purchases, owns or sells the product. Their activity consists solely of negotiating independently and on behalf of another legal or natural person in relation to the sale or purchase of a product. What is the difference between brokering and wholesaling?
Wholesaling includes all activities consisting of procuring, holding, supplying or exporting medicinal products, other than activities involving the sale or supply of such products to the public.
Brokering does not involve any of these activities and, as mentioned above, only involves the negotiation of these activities on behalf of another legal or natural person in relation to the sale or purchase of a product.
If a company only purchases and sells on medicinal products for human use, and never physically handles the product, are they a broker?
No. If a company is purchasing or selling medicinal products for human use these activities constitute wholesaling and must hold a wholesale authorisation. As a broker operating in Ireland, what new requirements does the Falsified Medicines Directive bring for my company?
A broker must comply with the requirements for brokers set out in the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013 and Directive 2001/83/EC as amended. The main requirements include the following:
1. Register with the HPRA. Please see the guidance on how to register as a broker: Guide to registration requirements for brokers of medicinal products in Ireland
, Application for registration of broker of finished medicinal products for human use
2. Comply with the relevant principles of Good Distribution Practice (GDP) as per the revised EU GDP Guidelines
published by the EU Commission on 7 March 2013. As an authorised wholesaler considering using the services of a broker, what does my company need to do?
Wholesalers must confirm that any broker they intend to engage the services of is registered with the Competent Authority of the member state in which they are located. The HPRA has published the registry of brokers located in Ireland for this purpose (see linked above). Wholesalers must also verify that the broker complies with the requirements contained within Chapter 10 of the revised EU GDP Guidelines
published by the EU Commission on 7 March 2013. Extract from Section 5.2:
If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10 (1). Further information
Please refer to the Guide to Registration Requirements for Brokers of Medicinal products in Ireland
for further information.