HALMED (Croatia) celebrates 10 years in the EU and welcomes data harmonisation across Europe

In December 2023, It had been 20 years since HALMED had established as a regulatory body for medicinal products and medical devices, and 10 years since HALMED had started taking part – as a full-time member – in the work of European regulatory network and in the implementation of European procedures.

Siniša Tomić, PhD, director of HALMED has highlighted the complexity of the regulatory system for medicines at the European level, but he stressed that this is exactly what makes that system so solid. he believes that we have a very good system,- but we certainly has room for further improvements. Given our public health role, HALMED is constantly engaged in finding solutions to achieve the sustainability of its regulatory system. “All the time, the agency applies new ways of optimizing and rationalizing administrative procedures, because the time we save to the users of our services also means saving resources”.

Representatives of the Swedish Medicinal Products Agency, Karin Gröndahl and Christer were invited to participate in the event and provide a European perspective and the key results obtained by the UNICOM project.

Croatia is one of the 11 countries which have decided to join the UNICOM consortium. It has played a pivotal role in transfering its experience and knowledge to other European countries. Furthermore, it is one of the countries which showed the highest level of engagement both at business and IT levels, clearly demonstrating a very high level of commitment.

“Complying with the ISO IDMP standards is not only needed for the agency but we want the standard to be also the fundation of ouf national Medicinal Drugs Dtabase which will is implemented with the support of other EU funded porject.” said Maja Lovrek Romčević, MPharm, Head of Medicines Authorization Division.

You want to know more about what Croatia has done to implement IDMP and how it has been done ?

Watch the knowledge transfer webinar and the interview with two key staff from the agency.