EMA: Templates for Medicine Shortage Prevention and Mitigation
EMA releases templates to assist marketing authorisation holders (MAHs) in creating plans to prevent and mitigate shortages. The EMA is urging MAHs in the EU/EEA Area to develop a plan to prevent shortages and minimise the likelihood of shortages for their marketed medicines.
- The plans should identify potential risks in the supply chain and outline measures to manage those risks.
- MAHs should also establish plans to mitigate shortages and address potential or actual shortages for their marketed medicines.
- These plans should include proposals on how to minimise the impact of a medicine shortage on patients.
The following templates are provided for MAHs to create their shortage prevention and mitigation plans:
- Medicine shortage prevention plan – template
- Medicine shortage mitigation plan – template
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
