TraceLink participates in ‘trial run’ serialization pilot in Ireland

By Maggie Lynch contact

- Last updated on GMT

(Image:Getty/utah778)
(Image:Getty/utah778)

Related tags: Serialization, European union, FMD

TraceLink, a company specializing in serialization, joined the Irish Medicines Verification Organization (IMVO) pilot program before EU FMD deadline.

The IMVO, a not-for-profit organization created to manage the Irish Medicines Verification System (IMVS), launched a pilot serialization program to connect hospitals, pharmacies, and clinics to the IMVS. TraceLink will join this pilot as part of an effort to protect patients from falsified medicines through serialization practices.

Leonie Clarke, IMVO project manager, told us, “It’s not a pilot in the classical sense of the word. One thinks of a pilot as a testing system before you release the system live. The system that’s being tested is fully live and fully functioning. So, it’s really a trial run of the whole thing before we go into the stage where it will be mandatory next year.”

The deadline for the EU FMD implementation regulations is February 9th, 2019. We reported that many companies are taking measures to work towards preparing for this deadline, with TraceLink developing technology platforms​ to ease the process. 

TraceLink’s Android and iPhone applications and a Bluetooth scanner to collect barcode data will be used in the pilot program. These applications aim to comply with verification and decommissioning requirements under the European Union Falsified Medicines Directive (EU FMD).

Graham Smith, general manager of healthcare and pharmacy at TraceLink told us, “TraceLink’s pharmacy application processes different transactions from the pharmacy and displays the response from the National System for the pharmacist.”

This response enables the pharmacy to be compliant with the requirements of the FMD. Smith further explained that the pharmacy mobile application is for both retail and hospital pharmacies.

Clarke said that they did not specifically pick TraceLink for the pilot but opened the program up to any IT software providers who wanted to provide assistance. She furthered that the IMVO is “delighted”​ to work with TraceLink and all the software providers on board with the program.

She remarked that “it’s very encouraging from our perspective that there are a number of providers.”

The key objective of this pilot is learning – the IMVO wants to learn any changes that they need to make to its systems or to make it as easy as possible for IT providers to come on board, according to Clarke.

EU FMD​ is an authentication system and according to Clarke implementing serialization programs for the system has been complex but necessary.

“At the end of the day, we’re making sure when patients go into pharmacies or hospitals they’re not getting falsified medicine. I think that’s a level of reassurance that’s important for patients and something we’ll be talking about as we move towards February 2019,” ​said Clarke. 

Related topics: Regulatory & Safety, Regulations

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