Dear Sir / Madam,
Please to share an important update for your kind perusal.
Serialisation dominates the discussion about how to implement the Falsified Medicines Directive (2011/62/EU). However, to meet the February 2019 deadline, companies need attention to the second required safety feature: the anti-tampering device. The use of tamper-evident labels is widespread.
The EU regulation does not specify how to implement an anti-tampering device. Both the directive 2011/62/EU and delegated regulation 2016/161 stipulate the safety feature but do not define any details. For this reason, stakeholders prepared the CEN standard EN 16679 entitled "
Tamper-verification features for medical product packaging
,“ which will be upgraded to
As requirements for tamper verification features on medicinal product packaging are emerging and expanding globally to further improve patient safety. This International standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products worldwide.
We hope that it would be of your interest and look forward for your valuable feedback.
Thanks and Regards,
Chander S Jeena