Status for 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 is currently working on a project to check the anti-tampering device (ATD) on selected medicinal product packages.
Approx. 10% of the packages requisitioned so far 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 to test their ATDs to avoid unauthorised access to the medicinal products.
The project is based on testing random samples of marketed medicinal products from the Danish market. The laboratory has 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/oblat/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/oblat/tape/sticker did not adhere very well to the cardboard.
The Laboratory has currently requisitioned 198 samples from a total of 136 companies. We have checked packages with as many different ATD´s as possible, including glue, fully glued, tape, perforated tape, label/oblat, perforated label/oblat and perforated cardboard. All companies involved have received individual results of the control.
The overall project is expected to be finalised in 2024.
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.
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 (laegemiddelstyrelsen.dk)