EMA publish EURD List

The EMA has published the list of EU reference dates and frequency of submission of periodic safety update reports (PSUR) known as the ‘EURD list’.

More information can be found here.

The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations.

The PSUR frequency and related data lock points in the EURD list take effect six months after the publication date and overrule the submission schedule described in Article 107c (2) of Directive 2010/84/EU, and any conditions related to the frequency of submission of PSUR included in the marketing authorisation.

Marketing authorisation holders are required to submit PSURs to the National Competent Authorities or the Agency according to the dates published in the EURD list.

If you’d like help with your PSURs, or require further advice or guidance, please contact us via our Contact page or by emailing enquiries@regulis.com