EC adopts delegated act on safety features

The European Commission formally adopted the delegated act on safety features for medicinal products on October 2, after publishing the text in August.

The adoption of the finalised text is just one more step on the path towards bringing the requirements into force - it still needs to be published in the Official Journal of the European Union, and will become mandatory three years from that date - likely either in late 2018 or early 2019.

The delegated act implements some of the wide-ranging requirements of the Falsified Medicines Directive (2011/62/EU) which aims to protect the public from counterfeit, stolen, expired and recalled medicines.

The document introduces a requirement for prescription medicines and select over-the-counter (OTC) drugs in the EU to carry a serialised unique identifier (UI) code within a 2D datamatrix barcode, anti-tampering device on the outer packaging, and verification of the UI at the point of dispensing.

It will apply to all EU member states apart from Italy, Belgium and Greece - which already have serialisation systems in place - as well as European Economic Area (EAA) countries Norway, Iceland and Liechtenstein plus Switzerland.

All pharma manufacturers, parallel traders, re-packagers and contract manufacturers will now have to make sure they have adapted their packaging lines and systems to comply with the delegated act by the deadline.

One change from earlier drafts that has made it into the finalised version is the transition period that will apply to allow already manufactured products to be sold after the act comes into force. Previously this had been capped at two years, but now the medicines will be able to be used until they expire.

Commenting on the adoption, the chief executive of medicines verification specialist Aegate - Mark De Simone - said: "The steps taken by pharmaceutical manufacturers and related organisations over the next few months are now vital to the success of the FMD."

"Much attention is being placed on the implementation of the serialisation and new 2D barcodes, which dramatically affect the manufacturing process, but the real complexity is the testing of the new codes within the authentication system," he added.

"With thousands of manufacturers in each country, a phased approach will be necessary and therefore three years is by no means a long period of time."