Definition

The date in the EU that determines the harmonized submission schedule for PSURs, as listed in the EURD list maintained by EMA.

Example

The EURD list specifies that all products containing ibuprofen have an EU reference date of June 1, ensuring synchronized PSUR submissions across MAHs.

Regulatory source

EU GVP Module VII

Common mistakes

Using the company's IBD instead of the EURD for EU PSUR timing.

Inspector question

How do you track EURD requirements? How do you handle products not on the EURD list?

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