Maurits Lugard, Dr. Dorothee Schramm, and Anna-Shari Melin from law firm Sidley & Austin explain how pharmaceutical companies with products on the EU market can address product shortages and supply chain issues in the current Covid-19 crisis.
Shortages
In order to address Covid-19 related shortages, pharmaceutical companies with products on the EU market should monitor Covid-19-specific guidance, but also comply with existing EU guidance on shortages. Further, companies are well advised to review their supply contracts.
Monitor Covid-19 specific guidance
The European Medicines Agency (EMA) published a Q&A notice to stakeholders on regulatory expectations and flexibility during the Covid-19 pandemic (the Q&A Notice, latest version available here).