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Earlier this month, the Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) task force on the availability of medicines for human and veterinary use released two guidance documents that seek to improve reporting and communication around medicines shortages. Both the ‘Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders in the Union’ and the ‘Good practice guidance for communication to the public on medicines’ availability issues’ 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 ‘Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders in the Union’ seeks to facilitate the detection and early notification of medicines shortages. The document contains a template for shortage notification which should be used by companies when communicating to national competent authorities. Both the guidance and the template will be tested during a pilot phase starting at the end of 2019.
The ‘Good practice guidance for communication to the public on medicines’ availability issues’ has been issued for the use by EU national competent authorities and EMA. It contains principles and examples of good practices for communication that should be adhered to when sharing information about medicines shortages with the public, patients and healthcare professionals. The guideline highlights the need for timely, accurate and up-to-date information on availability issues to ensure continuity of care.
The HMA/EMA task force was set up in 2016 to look at availability issues, including medicines that are authorised but not marketed, as well as at supply chain disruptions, in order to improve continuity of supply of human and veterinary medicines across Europe.
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Competing interests None declared.
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