New EMA guidance on how to manage medicinal product shortages

24 October 2019

Maurits Lugard and Anna-Shari Melin from law firm Sidley Austin provide an Expert View on the European Medicines Agency’s (EMA) recent guidance on medicinal product shortages and implications of this guidance.

The EMA, together with the Heads of Medicines Agencies (HMA), recently published new guidance for marketing authorization holders (MAHs) and regulators to address medicinal product shortages. This new guidance aims to clarify European Union (EU) law obligations and puts a strong focus on the adequacy of companies’ supply management and shortage detection processes.

New guidance for MAHs

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