10/11 March 2021
On 30 November 2018, the International Organization for Standardization (ISO) published the new ISO standard 21976:2018 entitled "Packaging - Tamper verification features for medicinal product packaging". This standard deals with possible types of tamper-evident seals to ensure the integrity of pharmaceutical packaging. As a basis for the ISO 21976:2018 standard, the DIN working group "Characteristics for checking manipulations on pharmaceutical packaging" proposed the European standard 16679:2014 "Tamper verification features for medicinal product packaging".
Pharmaceutical companies that have prescription drugs in their portfolio must provide these with two security features as of 9 February 2019 in accordance with the Anti-Counterfeiting Directive 2011/62/EU. There are exceptions to this obligation, but for most prescription-only medicines it applies that, from this date at the latest, the (secondary) medicinal product packaging must not only have an individual identification feature but also tamper protection (tamper-evident closure), the so-called "Anti Tampering Device". The delegated EU Regulation 2016/161 provides details on the individual identifier, but not on the technical specifics regarding the device against tampering.
The Question and Answer paper of the EU Commission recommends (in its current version 12 under 1.14.) the CEN standard EN 16679:2014 "Tamper verification features for medicinal product packaging". This standard specifies requirements for tamper evidence for medicinal product packaging and provides guidance on the application, use and verification of the tamper-evident closure. There is a wide range of choices for manufacturers. The ISO standard largely follows the European standard. Manufacturers are therefore not required to make any changes to packaging materials that have already been converted to prepare for the anti-counterfeiting directive.
The ISO Standard 21976:2018 Packaging - Tamper verification features for medicinal product packaging is available for purchase from the International Organization for Standardization.