European Medicines Agency launches public catalogue of medicine shortages assessed by the Agency
The European Medicines Agency has launched a public catalogue that contains information on supply shortages of medicines.
The catalogue includes information on medicine shortages affecting more than one Member State and that have been assessed by the Agency.
The aim of the catalogue is to offer a reference point for stakeholders for up-to-date information on shortages that have been assessed by the Agency.
The catalogue provides:
- information on the reason of the shortage and the current status of the shortage (ongoing or resolved)
- information on the extent of the shortage;
- specific information for patients and healthcare professionals;
- links to relevant related documents.
Over the past few years, there have been a number of public-health crises caused by supply shortages of medicines as a result of manufacturing issues and good-manufacturing-practice (GMP) compliance problems.
Shortages can have important consequences for patients and healthcare professionals, such as the need to switch to an alternative treatment and the setting-up of priority-access programs.
The creation of this catalogue is part of an implementation plan developed by the Agency in 2012 to help the European medicines regulatory network deal with medicine supply shortages following manufacturing problems. This short- and medium-term plan includes a number of actions that aim to prevent, mitigate and manage shortages of medicines.
As part of these planned actions, the Agency held a workshop on the prevention of medicine shortages due to manufacturing and quality problems in October 2013. The workshop aimed to discuss how to improve existing risk-management strategies and how to mitigate the impact of shortages. A workshop report will be published shortly.
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- Medicine shortages
- Shortages catalogue
- Workshop on product shortages due to manufacturing and quality problems: Developing a proactive approach to prevention
- Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems (2012-11-23)
- Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems - Implementation plan 2012-2015 (2012-11-23)