GDP – Revised rules in the EU – 2013/C 68/01

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).

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The revised guidelinespdf will enter into force in six months from the date of publication, on 8 September 2013.