Brussels – The European Generic and Biosimilar Medicines Association (EGA) welcomes the publication in the official journal today of the Delegated Regulation supplementing Directive 2001/83/EC, which implements the Falsified Medicines Directive (2011/62/EU), on the safety features appearing on the packaging of medicines.
This Delegated Regulation will determine the technical specificities of the Unique Identifier and the repositories system that will enable the verification of the authenticity of individual packages of (mainly) prescription medicines.
Together with stakeholders (EFPIA, EAEPC, GIRP, PGEU), EGA will work to ensure the national implementation of an interoperable, pan-European repositories system, called the European Medicines Verification blueprint System.
Adrian van den Hoven, Director General of the European Generic and Biosimilar medicines Association (EGA) said “We are confident that the implementation of the European Medicines Verification Blueprint System will be a major step forward for the fight against counterfeit medicines. To ensure that our industries continue to deliver access to high quality medicines and to improve patient safety, we plan to work closely with Member States to allow the industries to apply voluntarily the safety features when needed to increase patient safety even more”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and @ebgbiosimilars.