Completion of the project regarding the control of anti-tampering devices (ATD) on medicinal product packages
Information for marketing authorisation holders (MAH).
The Danish Medicines Agency's laboratory has completed a project in which the anti-tampering device (ATD) on random samples of selected medicinal product packages has been checked.
Approx. 10% of the packages requisitioned had an ATD that did not work. The flawed devices are designed as a sticker, that can be removed without it being visible on the packaging.
We encourage marketing authorisation holders (MAH) to test their ATDs to prevent unauthorised access to the medicinal products without tamper evidence.
The project was based on testing random samples of marketed medicinal products from the Danish market. The laboratory requisitioned medicinal product packages and attempted to open the package by removing the ATD without it being visible on the packaging.
Of the controlled medicinal products, approx. 10% were found to have a non-functioning ATD, where we were able to access the medicine without it being visible on the packaging.
The non-functioning ATDs were exclusively those that were designed as a label/oblate/tape/sticker with or without perforation. If the packaging was made of glossy or coated cardboard, it was often particularly easy to remove the ATD, as the label/oblate/tape/sticker did not adhere very well to the cardboard.
The Laboratory requisitioned 213 samples from a total of 148 companies (MAH). We have checked packages with as many different ATD´s as possible, including glue, fully glued, tape, perforated tape, label/oblate, perforated label/oblate and perforated cardboard. All companies (MAH) involved have received individual results of the control.
The regulations on safety features came into force on the 9th February 2019 and apply to prescription-only human medicinal products. The regulations are intended to prevent counterfeit medicinal products from entering the legal supply chain for medicinal products. An ATD should make it possible to check whether a package has been tampered with before the package is handed over to the patient.
Please refer to the regulation 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.
Information about safety features can be found on the Danish Medicines Agency's website: Q & A about safety features on the packaging of medicinal products