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EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages

Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the Prevention of Human Medicinal Product Shortages".


"A shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level".

European Medicines Regulatory Network (EMRN) and other international organisations recognize that medicine shortages are a global problem. Over the years, shortages have become increasingly prevalent in European countries, with a substantial impact on patient care.


As part of this document, marketing authorisation holders, wholesalers, distributors, and manufacturers are encouraged to adopt good practices for the prevention of shortages in human medicine, such as reducing the probability of shortages occurring in the first place. Recommendations on mitigating a shortage event are also included.


This guidance covers aspects such as supply chain management, risk assessment, communication, and contingency planning to ensure the continuity of medicine supply. The guidance aims to promote collaboration and proactive measures within the industry to minimize the impact of shortages and ensure the availability of necessary medicines for patients.


To maximize the opportunity to prevent potential shortages from occurring or limit their impact, notifications should be submitted earlier in advance of potential shortages and detail should be more accurate.


As part of this document, ten recommendations have been identified that can be used to implement preventative strategies, and there is a need to optimize notifications of potential and actual shortages.



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