The European Union taskforce set up to address problems with medicines supply has published two documents:
- guidance for marketing authorisation holders on reporting of shortages in the EU; and
- good practice guidance for communication to the public on medicines’ availability issues.
The taskforce was established by EU regulators to better address potential problems with medicines’ supply and to develop and co-ordinate actions to facilitate the prevention, identification, management of and communication about shortages.
Both documents lay the foundations for an improved and harmonised EU approach in reporting of and communication on medicines’ shortages and availability issues, a key public health priority for the EU network.
The first document provides guidance to the pharmaceutical industry to facilitate the detection and early notification to competent authorities and includes a proposed template for shortage notification by companies. The guidance and template will be implemented in a pilot phase, planned to start in the last quarter of 2019.
The second document, addressed to EU national competent authorities and the European Medicines Agency, lays out principles and examples of good practices for communication on shortages to the public, including patients and healthcare professionals. The guidance is based on a survey carried out on the issue by the taskforce in all EU Member States.