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EMA: Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems

29.11.2012
This Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and affecting medicinal products for human use, independent of their route of authorisation, where a need for co-ordination of the assessment and risk reducing actions at a Community level has been identified.

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