DIRECTIVE 2011/62/EU amending Directive 2001/83/EC

The new Directive 2011/62/EU amending Directive 2011/93/EC was published on July 1, 2011, in the Official Journal of the European DIRECTIVE 2011-62-EU amending Directive 2001-83-ECUnion.

The new legislation will be applicable on 2 January 2013. The new legislation introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled.

To this end, these new measures include:
  • An obligatory authenticity feature on the outer packaging of the medicines : this feature will be decided at a later stage via a delegated act
  • A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors


Further information:

Full Text Directive 2011/62/EU

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