Guidance for medicines’ supply issues published
15. Juli 2019 – The European Union task force established by EU regulators to address issues with supply of medicines published two documents on 4 July 2019. Both documents aim at a harmonised approach in reporting of and communication on shortages and availability problems related to medicines, which is a key public health priority for the EU. The first document, named “guidance for marketing authorisation holders on reporting of shortages in the EU”, provides guidance to the pharamaceutical industry, inter alia by introducing a common definition of the term “shortages”, in order to facilitate the detection and management of issues with the supply of medicine. Together with a template for shortage notification by companies, the guidance will be in a pilot phase starting in the last quarter of 2019. The second document named “good practice guidance for communication to the public on medicines’ availability issues” addresses the EU national competent authorities and the European Medicines Agency (EMA). It lays out principles and examples of good practices for communicating to the public, including patients and healthcare professionals (for further information, see here).