Technical / White Paper
New Guidelines Strengthen Good Distribution Practice (GDP)
The recently introduced EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C 68/01 and updated on November 5th 2013 as 2013/C 343/01) places significant new demands on the manufacturers and distributors of pharmaceutical products.
Partly driven by the need to prevent counterfeit and falsified medicines from entering the legitimate supply chain, 2013/C 343/01 sets out the necessary requirements to ensure compliance with Directive 2011/62/EU, the 'Falsified Medicines Directive'.
Moreover, the new guidelines also take account of the challenges (and opportunities) presented by new technologies and increasing globalisation, which have come about since the previous version was published in 1994.