Brokers Registration

Brokers of medicinal products based in the UK must register their activities with MHRA and may be subject to inspection at their registered premises.

Brokering activities are defined as 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.

Brokers must comply with certain requirements, some of which include:

• A quality system that is defined in writing, kept up-to date and sets out responsibilities, processes and risk management in relation to activities.
• Training of personnel involved in brokering activities.
• Compliance with the GDP requirements for documentation and must have at the least, procedures for ensuring that medicinal products brokered have a marketing authorisation; handling of complaints; for informing the competent authorities of suspected falsified medicines and supporting recalls; and for verifying that the wholesale distributor or manufacturers/importers hold a distribution authorisation or manufacturing authorisation as appropriate.

We can provide the required procedures and training, assist with the initial application and with the annual compliance report required in April each year.