ISO DIS 21976

Description / Abstract: This International 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 International Standard meets, as an example but not limited to, the requirements of Directive 2001/83/EC^[1] as amended by Directive 2011/62/EU^.[2] 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 International Standard can be applied in other countries, jurisdictions and sectors, as appropriate.