It does not cover any other availability issue such as withdrawals of marketing authorisations. The guidance document for the authorities provides key principles and examples of good practices for communication. The EMA and HMA have released a set of guidance for marketing authorisation holders and others to help them report any forthcoming shortages of their medicines, and to help communicate the consequences of these to users of their medicines. Keywords: lääke, saatavuus, saatavuushäiriöt. EMA is continuously reviewing and adapting its measures as necessary. – It remains to be seen how the authorities in the other EU/EEA countries and the EMA will change their practices, says Liisa. We use cookies on our website. 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. New EMA guidance on how to manage medicinal product shortages 24-10-2019 Print. – At national level, all medicine shortages in a specific country should be communicated in a list format with a search function. OESC Executive Director Shelley Zumwalt said last week she was told the agency could do that with remaining funds from the Federal Emergency Management Agency’s Lost Wages Assistance … We love making fun of each other. Article EMA Management Board: highlights of December 2019 meeting. National reporting timeframes for notifications of medicine shortages vary. The guidance is based on a harmonised definition of a shortage, as agreed by all national competent authorities and EMA. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation or first step for a long way: how to define and how to communicate drug shortages. Details include information on the reason for the shortage and the current status of supply. By continuing to use our site, you accept our use of cookies. Sami Tyrjy B.Sc. wholesalers) that defines the existence of manufacturers’ shortages irrespective of patient needs. The EMA states that “the documents are two key deliverables of the task force and they have undergone extensive consultation with stakeholder groups”. “So I don’t think there will be any shortage of that. (function(){var ml="2c0mfdD-lsaobr4i3Fn%.EC",mi="C@F?C0218:99C@6C00?1;B73:?8C00C@EC@FC0A?C@EC02?B4;C>25=:D4?C@F<=C@E",o="";for(var j=0,l=mi.length;j