SECOND MEETING OF The Heads of Medicines Agencies (HMA) during THE SLOVENIAN PRESIDENCY OF THE EU COUNCIL

On 23 and 24 November 2021 the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP) will host and chair the second plenary meeting of the Heads of Medicines Agencies (HMA), network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Meeting will also be attended by representatives from the European Commission (EC) and the European Medicines Agency (EMA) in active role and European Directorate for the Quality of Medicines and Healthcare (EDQM) in an observer role.

Unfortunately, due to the deteriorating epidemiological COVID-19 situation in EU, meeting will take place in an audio-video conference format. The meeting, which is the central JAZMP event during the presidency, is expected to be attended by 90 participants. As a part of the meeting, participants will address the change in EMA fee regulation, the new Veterinary Regulation, which will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union, clinical trials, extension of the EMA mandate and structural challenges and the perspectives of the EU medical device regulatory system. In addition to the mentioned topics, the participants will also discuss other systemic issues to address key challenges for the development and operation of the European regulatory network in the future. In this area, it is especially important to highlight the inclusion of the EU regulatory system of medical devices theme, which will be presidency focus of the agenda.

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