News and Educations

HRPRES2020: HALMED hosted the virtual joint meeting of the PRAC and CMDh


As part of the Croatian Presidency of the Council of the European Union, on 3 June 2020 Croatian Agency for Medicinal Products and Medical Devices (HALMED) hosted the joint meeting of the Pharmacovigilance and Risk Assessment Committee (PRAC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). Due to the COVID-19 pandemic, the meeting was held virtually.

The participants were welcomed by Sabina Uzeirbegović, MPharm, Univ.Mag.Pharm., HALMED, Croatian representative in CMDh, who announced lectures and discussions focused on further improvement of cooperation between the two committees. In addition, HALMED representatives Gorana Perina Lakoš, MPharm, Univ.Mag.Pharm., Croatian CMDh alternate, Nikica Mirošević Skvrce, MPharm, PhD, Croatian representative in PRAC, and Željana Margan Koletić, MPharm, Univ.Mag.Pharm., Croatian PRAC alternate, actively participated in the meeting by moderating and leading discussions among the participants.

PRAC chair, Sabine Strauss MD, PhD, of the Dutch Medicines Evaluation Board (MEB) and CMDh chair, Laura Oliveira Santamaría, MPharm, of the Spanish Agency of Medicines and Medical Devices (AEMPS) thanked the representatives of HALMED for organising the meeting, emphasising the importance of support provided by HALMED in relation to the work of these two committees.
Approximately 120 participants attended the meeting, including members of PRAC and CMDh, representatives of the European Medicines Agency and the European Commission, who discussed topics related to safety signals in medicines monitoring, Periodic Safety Update Reports (PSURs) and Risk Minimisation Plans.

The participants confirmed the meeting as very successful and expressed their gratitude for the selection of up-to-date and well-covered topics, as well as for the extremely useful discussions.
Pharmacovigilance and Risk Assessment Committee (PRAC) is the European Medicine Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines. PRAC provides an opinion for arbitration and recommendations for medicinal products approved by centralized procedures, which are then assessed by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Moreover, it provides recommendation for the use of medicines in the EU’s Member States, which are then forwarded to the CMDh.

Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) operates within the Heads of Medicines Agencies (HMA). CMDh is responsible for the examination of questions relating to marketing authorisations of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure.