Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) CHAPTER 10 — SPECIFIC PROVISIONS FOR BROKERS
The quality system of a broker should be defined in writing, approved, and kept up to date. It should set out responsibilities, processes, and risk management in relation to its activities. The quality system should include an emergency plan which ensures the effective recall of medicinal products from the market ordered by the manufacturer or the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned. The competent authorities must be immediately informed of any suspected falsified medicines offered in the supply chain.
Any member of personnel involved in brokering activities should be trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products.