Regulatory Focus™ > News Articles > EU Falsified Medicines Directive Could Result in Drug Shortages

EU Falsified Medicines Directive Could Result in Drug Shortages

Posted 12 December 2012 | By Alexander Gaffney, RAC 

The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.  

The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing practices (GMP) or at the very least an acceptable standard equivalent to the GMP of the EU. 

Imports must also either be accompanied by a written confirmation from the exporting country's competent authority that the API was produced according to applicable GMP standards, or a waiver by an EU member state stating the manufacturing plant has passed inspection by an EU competent authority.

The HMA believes that because of the Directive's requirements, the main API producing countries will no longer be able to export to the EU. The HMA is working on developing possible harmonized national regulatory approaches that would lessen the likelihood of drug shortages, and has convened a special Taskforce on Falsified Medicines, chaired by Spain's national agency (AEMPS) for that purpose.

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