New EU Good Distribution Practices of Medicinal products

Wholesale distribution of medicinal products includes "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned".

The new EU Good Distribution Practices of Medicinal Products for Human Use (2013/C68/01) were published in March and will come into force in September. The main changes with respect to the previous version (dated 1994) are that it now covers the whole distribution chain and all the firms involved (regardless of their location, even in free zones, and including brokers). It also applies to products for export only. It strengthens the requirements of Quality Assurance (QA) systems and traceability so as to limit the entry of faked products.  

The revised 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 relating to the sale or purchase of medicinal products).

On the 8 September 2013 the new guideliness will be published and they will come into force six months from the date of publication. 

The revised guidelines