Guideline to Register as a Broker of Medicinal Products

Recommendation

Wednesday, 27 January 2021 14.00 - 15.30 h

Webinar: Responsibilities at GDP

All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. According to the definition a broker is involved in independently selling or buying medicinal products on behalf of another company. As per definition a broker does not buy or sell the products, does not own the products and does not physically handle the products.

For some countries in Europe (Belgium, Spain, France, Croatia, The Netherlands, UK) the so called "Heads of Medicines Agency" provide a database to complete a Broker application. This application is the prerequisite to submit an application to the agency in the above mentioned countries. The UK for example does have a register of Brokers for Medicinal Products on their website. Currently 20 companies are listed there.

The MHRA has defined very detailed requirements which brokers have to fulfil before they are registered. The MHRA will:

• check the identities of the ‘responsible person’ and other named staff
• will perform a GDP inspection at the site of the broker
• interview the members of the staff of the broker

If the inspection was successful a GDP certificate will be issued and transferred to the EudraGMDP Database. This comprehensive control of brokers is not established in each EU country yet but other agencies might follow the example of the MHRA.

Source: MHRA Webpage for Brokers