A new guidance has been published by the European Medicines Agency as part of its effort to prevent and mitigate medicines shortages. The document addresses the best practices the industry should follow in order to ensure continuity in the supply of human medicines. The ten recommendations are targeted to marketing authorisation holders, wholesalers, distributors and manufacturers.

Stakeholders are called to inform national competent authorities of potential or actual shortages as early as possible. Greater transparency as for the provided shortage information and the accuracy of notification detail is also requested to MAHs and other relevant stakeholders. Furthermore, each of them (in particular, MAHs, distributors and wholesalers) should establish a robust shortage prevention and management plan reflecting their respective roles. Optimisation of the pharmaceutical quality systems should represent another target for the industry, which should also take into due consideration known vulnerabilities in order to improve the resilience of complex, multinational supply chains.

A timely communication along the entire medicine supply chain, the respect of a fair and equitable distribution of medicines to meet the needs of patients, and the minimisation of the risk of parallel trade or export exacerbating shortages are other recommendations.