News and Educations

Viola Macolić-Šarinić - new director of the Agency for Medicinal Products and Medical Devices


On 1 December 2011, the four-year mandate at the helm of the Agency for Medicinal Products and Medical Devices began for new director Viola Macolić-Šarinić, MSc. The Agency's Executive Board selected Ms. Macolić-Šarinić as the new director following a public competition at its 46th session held on 21 September 2011.

In her mandate, Ms. Macolić-Šarinić plans to develop and strengthen the internal structure of the Agency, which implies not only its human resources, but also making the appropriate technical preparations to ensure the Agency continues its intensive preparations for functioning within the integrated European regulatory area. She will work towards improving the transparency of the regulatory system and ensure access of information to the general public, and will stimulate the development of efficient assistance procedures which should ensure Croatian citizens have access to the safest medicinal products. She will also continue to develop strong cooperation with the European and international bodies authorised for medicinal products and medical devices, and will encourage the ongoing role of the Agency in implementing the acquis communautaire of the European Union, ensuring the continuing alignment with amendments to the European legislation in the field of medicinal products and medical devices.


Information for EudraVigilance users


The European Medicines Agency (EMA) needs to carry out essential maintenance on its IT Infrastructure systems and the HALMED ICSR e-reporting will also be affected.

The EudraVigilance Production Environment will not be available from Friday 12th of August from 18.30 p.m. onwards until Monday 15th of August, 10.00 a.m.

During the above periods the following modules of the EudraVigilance System will be unavailable:

- EudraVigilance HALMED database: acknowledgements from the EudraVigilance system should not be expected before Monday (acknowledgement type 01, 02 and 03)
- EudraVigilance Web Application (including Post-Function)
- EV Gateway.

The delay for sending SUSARs to HALMED will not have any compliance implication for the marketing authorization holders.

We apologise for any inconvenience caused by the interruption of the service.


A Dear Healthcare Professional letter to physicians concerning the prescribing of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets: post-marketing reports of pure red cell aplasia (PRCA)


In collaboration with the Agency for Medicinal Products and Medical Devices, the marketing authorisation holder in the Republic of Croatia, Novartis Hrvatska d.o.o., sent A Dear Healthcare Professional letter to prescribing physicians with the latest information on the safety of the medicinal product Myfortic (micophenolic acid) gastro-resistant tablets.