CEN - EN 16679
Packaging - Tamper verification features for medicinal product packaging
| Organization: | CEN |
| Publication Date: | 1 December 2014 |
| Status: | inactive |
| Page Count: | 22 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medicaments): | 11.120.10 |
| ICS Code (Packaging and distribution of goods in general): | 55.020 |
scope:
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.
Document History
