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
10.2. Quality System 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 their activities. The quality system should include an emergency plan which ensures 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 authorisation holder for the medicinal product concerned (4). The competent authorities must be immediately informed of any suspected falsified medicines offered in the supply chain (5).
10.3. Personnel Any member of personnel involved in the brokering activities should be trained in the applicable EU and national legislation and in the issues concerning falsified medicinal products.
PHARMA&BIOTECH SOLUTIONS DECLARED ITS BROKERAGE BUSINESS ON JUNE 2016 TO THE ZLG