Q4 2019

EU BUSINESS NEWS / Q4 2019 21 New European Medicines Agency Guidance on How to Manage Medicinal Product Shortages Conclusion The new guidance is an important first step to providing greater clarity to MAHs on their obligations under EU law with respect to the management of supply and detection of shortages, and to regulators on their obligations to communicate on medicinal product availability issues. MAHs should expect more scrutiny by regulators of their supply and potential shortage management. MAHs should consider reviewing their supply management and shortage detection processes and update those processes where necessary to bring them in line with the new guidance.