European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
The European Medicines Agency has published the list of European Union (EU) reference dates and frequency of submission of periodic safety update reports (PSURs) known as the 'EURD list'.
The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of PSURs and related data lock points. The EU reference date corresponds to the date of the first marketing authorisation of a medicine containing that active substance or that combination of active substances in the EU, or alternatively the earliest of the known dates of the marketing authorisations for a medicine containing that active substance or that combination of active substances.
The PSUR frequency and related data lock points for a given active substance or combination of active substances 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 national competent authorities or the Agency according to the dates published in the EURD list.
Marketing-authorisation holders and other stakeholders can request amendments to the EURD list for the following reasons:
- public health;
- to avoid a duplication of the assessment;
- to achieve international harmonisation.
To request an amendment, stakeholders must complete the template and send the requests to firstname.lastname@example.org.
Any changes to the list, following a request for amendment, are approved by the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the Pharmacovigilance Risk Assessment Committee (PRAC). Changes take effect six months after the publication date of the amended list for the products containing the concerned active substance or combination of active substances.
The EURD list aims to support and optimise the management of PSUR submission and PSUR (single) assessment within the European Economic Area.
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- 2010 pharmacovigilance legislation
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- List of organisations that provided comments during the public consultation on the European-Union-reference-date list (2012-11-05)
- Template for a request for amendments of or addition of active substances or combinations of active substances to the European Union reference-date list (2014-09-05)
- Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (2016-10-26)