The ‘Falsified medicines directive’ (2011/62/EU) and the ‘Pharmacovigilance regulation’ (No 1235/2010) will influence some of the information that patients receive about medicines. In both the directive and the regulation, several forms of visual communication are mentioned.
In this discussion piece Dr Karel van der Waarde explores the impact of the latest falsification and pharmacovigilance regulation on pharmaceutical packaging.
The anti-counterfeit packaging market is forecasted to reach US$206.57 billion by 2021, just shy of doubling its 2016 figure of $107.26 bn. This growth is supported by the expanding pharma and food and beverage industries, with Asia Pacific set to take the largest market share. China is earmarked to lead the way in 2021 with its drive in manufacturing activities fueling that lead.
The anti-tampering market is littered with challenges to address: meeting EU FMD requirements, satisfying country specific requirements, preserving patient usability and not to mention outwitting resourceful counterfeiters. In this ebook we look at the road to meeting the 2019 FMD deadline, finding the most suitable anti tamper evidence feature as well as patient compliance and future trends in the industry.
Edelmann GmbH/ Convenor of ISO TC 122 WG 15 “Tamper Verification Features on medicinal product packaging