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    European medicines regulatory network published two documents to better aadress potential problems with medicines supply and shortages

    05.08.2019
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    EU regulators established two documents 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 task force was set up by EMA and the Heads of Medicines Agencies (HMA), with representatives from the European Commission and national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the GMP/GDP Inspectors Working Group, the Working Group of Communication Professionals (WGCP) and the European Surveillance Strategy Working Group (ESS WG).

    Documents are available here:

    https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-detection-notification-shortages-medicinal-products-marketing-authorisation-holders-mahs_en.pdf

    https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guidance-communication-public-medicines-availability-issues_en.pdf