Industry news

Brokers - EU Falsified Medicines Directive requirements

With respect to brokers the FMD now requires:

• Persons brokering medicinal products shall have a permanent address and contact details in the Union so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities. (Article 85b), and
• Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holder must verify that the broker involved fulfils the requirements set out in this Directive. (Article 80)

The UK MHRA has confirmed that this means that companies in the EU cannot use brokers located outside of the EU/EEA. This is likely to present difficulties for many organisations as, for example, they often use brokers in countries like Switzerland to buy and sell product and ingredients for tax reasons. This will no longer be possible.