Definition

The EU procedure where one member state assesses a PSUR on behalf of all member states where the product is authorized.

Example

Germany is the lead member state for assessing Drug X PSURs. Their assessment and recommendations apply across all EU member states through the single assessment procedure.

Regulatory source

EU GVP Module VII

Common mistakes

Submitting to individual member states instead of using the centralized single assessment procedure.

Inspector question

How do you interact with lead member states during PSUR assessment? How do you implement recommendations?

Related terms