Persons procuring, holding, storing, supplying or exporting medicinal products are required to hold a wholesale distribution authorisation in accordance with Directive 2001/83/EC which lays down the rules for the wholesale distribution of medicinal products in the Union.

However, the distribution network for medicinal products may involve operators who are not necessarily authorised wholesale distributors. To ensure the reliability of the supply chain, Directive 2011/62/EU, the Falsified Medicines Directive extends medicine legislation to the entire supply chain. This now includes not only wholesale distributors, whether or not they physically handle the medicinal products, but also brokers who are involved in the sale or purchase of medicinal products without selling or purchasing those products themselves, and without owning and physically handling the medicinal products.

Brokering of medicinal products is defined in the Falsified Medicines Directive and means:

All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.

To accord with the Directive brokers may only broker medicinal products that are the subject of an authorisation granted by the European Commission or a National Competent Authority.

Brokers should be established at a permanent address and have contact details in the EU and may only operate following registration of these details with the National Competent Authority. In the UK this is MHRA. A broker must provide required details for registration which will include their name, corporate name and permanent address. They must also notify any changes without unnecessary delay. This is to ensure the brokers accurate identification, location, communication and supervision of their activities by the National Competent Authorities.

Brokers can negotiate between the manufacturer and a wholesaler, or one wholesaler and another wholesaler, or the manufacturer or wholesale dealer with a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale or a person who may lawfully administer those products.

Brokers are not virtual wholesale dealers; the definition of “Brokering medicinal products” specifically excludes the activity of “wholesale dealing”. Wholesale dealing and brokering of medicinal products are separate activities. Therefore wholesale dealers who wish to broker will require a separate registration, because:

● EU legislation defines wholesale distribution and brokering a medicinal product separately;

● wholesale dealers are licensed;

● the brokering of medicinal products is subject to registration.

UK based companies that broker medicinal products and are involved in the sale or purchase of medicinal products without selling or purchasing those products themselves, and without owning and physically handling the medicinal products are considered to be brokers and will have to register with MHRA.