Mandatory Drug Anticounterfeiting Measures Take Effect in the EU

By Patricia Van Arnum - DCAT Editorial Director

February 8, 2019

As part of the implementation of the European Union’s Falsified Medicines Directive, the European Medicines Agency (EMA) has highlighted that most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are required as of February 9, 2019 to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

These mandatory safety features are a key measure of the Falsified Medicines Directive, which is part of the EU’s strategy to strengthen the security of the supply chain of medicines. The safety features are implemented through a delegated regulation that comes into application on February 9, 2019. It will apply in all member states of the EU and the European Economic Area (EEA), which includes the EU member states, and Iceland, Liechtenstein, and Norway. The exceptions are Greece and Italy, which will have until 2025 to update their already existing tracking systems.

”The safety features will help protect European citizens against the threat of falsified medicines, which may contain ingredients, including active ingredients, which are of low quality or in the wrong dosage and could potentially put patients' health at risk,” said the EMA in a February 8, 2019 statement. “The unique identifier and the anti-tampering device on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients and will strengthen the security of the medicine supply chain, from manufacturers to distributors to pharmacies and hospitals.”

Under the system, manufacturers will upload the information contained in the unique identifier for each individual medicine to a central EU repository. The repository is part of an end-to-end medicines verification system introduced by the regulation. Depending on the source of the medicine, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients. Although the safety features are now a legal requirement, medicines that were released for sale or distribution without the safety features before February 9, 2019 can still be dispensed.

In addition, a new reporting form is available on the EMA’s website to be used by pharmaceutical companies when notifying the EMA of any suspected falsification of their centrally authorized medicines. The new form is specifically for notifications related to suspected and confirmed falsified medicines and suspicious offers.

Source: European Medicines Agency