EC Publishes Update Guidelines for GDP

The European Commission has published revised guidelines on Good Distribution Practice in the European Union

This introduces 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 guideline will come into force 6 months after publication, on the 8th September 2013.

Further information on the update can be found on the EC website:

https://ec.europa.eu/health/human-use/good_distribution_practice_en

The revised guideline can be viewed using the following link:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:068:0001:0014:EN:PDF