ΕΛΟΤ ΕΝ 16679
Packaging - Tamper verification features for medicinal product packaging
Abstract
This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products. NOTE The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. Article 54(o) of the Directive stipulates, that on the outer packaging of certain medicinal products or, where there is no outer packaging, on the immediate packaging shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with". The principles in this European Standard can be applied in other countries and sectors, as appropriate.
Info
The standard has been withdrawn
Publication Date
2015-05-15
Withdrawal Date
2020-12-22
Greek Title
Συσκευασία - Χαρακτηριστικά επαλήθευσης παραποίησης για συσκευασία φαρμακευτικών προιόντων
English Title
Packaging - Tamper verification features for medicinal product packaging
Standard Stage
Techincal Body
TE 46Replaced by
ΕΛΟΤ EN ISO 21976:2020Related Documents