The revised GDP guidelines introduce the following changes:
- the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
- suitable documentation which prevents errors from spoken communication;
- sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
- adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
- appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
- outsourced activities correctly defined to avoid misunderstandings;
- rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
- Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).
The revised guidelines will enter into force in six months from the date of publication, on 8 September 2013.