What is the European safety referral used for?

19.07.2021

Question of the Week

A European safety referral is used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

[GMP Compliance Adviser, Chapter 21.G]

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