Regulatory Focus™ > News Articles > Revised EU Distribution Rules Target Falsified Medicines

Revised EU Distribution Rules Target Falsified Medicines

Posted 12 March 2013 | By Louise Zornoza 

The European Commission issued final revised Good Distribution Practices (GDP) guidelines on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU. 

A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequate."  In February 2012, the Commission published the comments that had been submitted by companies, trade associations and European member states in response to the consultation.

The amended GDP guidelines take effect in September 2013 and include the following changes:

  • Maintenance of a quality system setting out responsibilities, processes and risk management principles
  • Suitable documentation which prevents potential verbal miscommunication
  • 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 (persons involved in activities in relation to the sale or purchase of medicinal products)

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe