Ukraine minister says medicines coding will follow EU model

Phil Taylor, 01-Jun-2020

Ukraine’s long-planned traceability system for medicines will be closely aligned with the EU system, according to a senior lawmaker.

Writing for the Interfax news agency, the chair of Ukraine’s Committee on National Health – Mykhailo Radutskyi – says the intention is still to start a pilot serialization programme on November 1 of this year, with a short roll-out to mandatory implementation a year later.

Like the safety feature regulations detailed in the EU’s Falsified Medicines Directive (FMD), Ukraine’s system will see a unique identifier in the firm of a 2D bar code added to each pack of medicine, including the medicine’s product code, lot number and expiration date, plus a unique, randomised serial number to allow verification. It also requires tamper-evident closures, just like the EU system.

Ukraine’s proposed timeline for the project was to identify organisations that would participate in the pilot and the list of medicines to be included in March, with a state system for serialization in place by October of this year.

One problem with the plans however was that the proposed code placement in legislation which came into effect last year wasn’t wholly compatible with the EU model, and Radutskyi says the Committee has now drawn up changes to the draft law on medicines to ensure it corresponds with European standards.

In January, a briefing by Ukrainian government muddied the waters by apparently suggesting that the unique identifiers would be assigned via a central database, which is very different from the EU where manufacturers create the identifiers themselves to upload to a central repository.

Radutskyi says in the blog post that experts estimate counterfeits make up 10 to 15 per cent of all medicines distributed in Ukraine, while up to 40 per cent of medical devices are either substandard or falsified.

“Our ultimate goal is to enable the buyer to check the origin of medicines with the help of a smartphone to see whether it is a counterfeit or an original one,” he concludes.