5 Months On – And How Are We Doing?
For those of us living in Europe, September is that month when that wonderful summer vacation taken in July and/or August is sinking ever faster from our memories. It is a time to remember when temperature control had more to do with cool beers, ice cubes in our vodka Martini and balmy summer nights.
But for many of us in the healthcare manufacturing, distribution and logistics sectors, September 8 had a more significant meaning to Temperature Management. After a six month implementation period, the latest version of the European Union Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) came fully into force. This set of revised GDP regulations also incorporates the requirements of the EU Falsified Medicines Directive.
The original set of GDP guidelines had been in force for almost two decades, and clearly revision was needed to reflect the considerable changes that had taken place in European distribution, import and export of medicinal products and particularly those having sensitivity to temperature control. The consultation period for these new guidelines generated a considerable amount of feedback from manufacturers, wholesales, distributors and other logistics stakeholders.