New safety requirements for EU medicines

Home/Policies & Legislation | Posted 15/03/2019 post-comment0 Post your comment

As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are legally obligated to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.

Health and Safety V15C26

These safety features are intended to protect patients and consumers against the threat of falsified medicines. Falsified medicines are fake medicines passed off as authorized medicines, which may contain ingredients which are of poor quality or in the incorrect dosage.

Manufacturers will upload the unique identifier codes for each individual medicine to a central EU repository. The repository is part of an end-to-end medicines verification system introduced by the new regulation. Depending on the medicine source, wholesalers will need to scan medicines at different points in the supply chain, and hospitals and pharmacies will then scan each medicine to verify their authenticity and check them out from the repository before dispensing them to patients. The anti-tampering device will show whether the packaging has been opened or altered since leaving the manufacturer, thereby ensuring the authenticity of the contents. These mandatory safety features form one aspect of the EU Falsified Medicines Directive aimed at strengthening the security of the medicine supply chain, from manufacturers to distributors to pharmacies and hospitals.

Although the safety features are now a legal requirement, medicines that were released for distribution or sale without the safety features before 9 February 2019 can still be dispensed.

Also, since February 2019, a new reporting form is available on the European Medicines Agency’s (EMA) website to be used by manufacturers when notifying EMA of any suspected and confirmed falsified medicines or suspicious offers. This will streamline reporting and investigating falsifications of centrally authorized medicines.

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Source: European Medicines Agency

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