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| The new GDP Guidelines apply to the wholesalers and manufacturers of pharmaceuticals and incorporate specific requirements for Brokers dealing with pharmaceutical products. |
Director Operations
CONCEPT HEIDELBERG GmbH
The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.
Here is the status quo of the Directive and the delegated acts:
Already in 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).The main goal was the fight against counterfeit medicines. In 2014 the technical characteristics of one key requirement were defined, the unique identifier delivering the possibility of verification of the authenticity of single folding boxes. This will be a 2D barcode (data matrix). As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.
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