The EU task force set up to address problems with medicines supply has published two documents today:
- Guidance for marketing authorisation holders on reporting of shortages in the EU
- Good practice guidance for communication to the public on medicines’ availability issues.
The task force was established by European Union regulators to better address potential problems with medicines’ supply and to develop and coordinate 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, a key player in addressing shortages, to facilitate the detection and early notification to competent authorities. The guidance is based on a common definition of the term « shortages », which should enable a more harmonised and timely approach in the detection and management of issues with the supply of medicines. A proposed template for shortage notification by companies is included in the guidance. The guidance and template will be implemented in a pilot phase, which is currently planned to start in the last quarter of 2019. Further information will be provided nearer the time.
The second document, addressed to EU national competent authorities and EMA, lays out principles and examples of good practices for communication on shortages to the public, including patients and healthcare professionals. These groups require timely, accurate and up-to-date information on availability issues to ensure continuity of care. The guidance is based on a survey carried out by the task force in all EUMember States to collect information on how issues related to shortages and availability of medicines are measured and communicated to the public…