EURD list for PSUR submission dates and PSUSA requirements
The EURD list sets EU PSUR frequencies and deadlines. Check the data lock point, reporting scope and PSUSA outcome before changing product information.
The EURD list is the European Medicines Agency's legally binding PSUR schedule for listed active substances and combinations. For those entries it sets the reporting frequency, the data lock point and the submission deadline for periodic safety update reports (PSURs). Get the current list from EMA's PSUR page. Read any PSUR single assessment (PSUSA) outcome separately to establish whether product information must change.
This guide covers EU requirements for marketing-authorisation holders. It does not establish reporting duties for UK or US products.
How to use the EURD list
Open the section called "Submission requirements and EU reference dates: the EURD list" on EMA's official page. Download the current list and its accompanying guidance rather than relying on a saved copy.
Start with the active substance or combination relevant to your product. Check whether the entry applies before taking dates into your reporting plan. If the scope is unclear, consult EMA's guidance rather than guessing whether a salt or derivative matches.
For an applicable entry, read the reporting frequency, data lock point, submission date and PSUR single-assessment procedure number. Check any requirements for product categories that are normally exempt from routine reporting. EMA describes these data elements in its PSUR questions and answers.
Keep the EU reference date separate from the reporting deadline. It means the first or earliest known EU marketing-authorisation date for a medicine containing that substance or combination. It is not the international birth date. The list's schedule overrides the standard PSUR cycle and authorisation conditions concerning reporting frequency. That precedence concerns PSUR scheduling, not every obligation in the authorisation. Authorities can still request a PSUR at any time.
If your substance or combination is absent
An absent entry does not establish that no PSUR is due. Follow the applicable authorisation conditions or standard schedule, subject to exemptions. For an unlisted fixed-dose combination, don't substitute the entries for its individual components. EMA addresses these cases in questions 5 and 6.
Generic status alone is not enough to rule out reporting. Generics and certain other categories are exempt from routine submission unless the authorisation or EURD list requires it. Authorities may also request reports. Hybrid products do not share that exemption, as EMA's questions 10 and 11 explain.
PSUR data lock point versus submission date
The data lock point, or DLP, is the data cut-off for the report. It isn't the filing deadline. The reporting interval sets the number of calendar days allowed after that cut-off, according to EMA's submission guidance.
| Reporting interval or request | Submission timing after DLP |
|---|---|
| Up to and including 12 months | Within 70 calendar days |
| More than 12 months | Within 90 calendar days |
| Ad hoc report | Follow the requested timeline; if none is specified, within 90 calendar days |
Exactly 12 months falls in the 70-day category. Don't assign 90 days simply because the report covers a full year. EMA states that the legally binding submission deadline appears in the EURD list and must be met. Use that published date for the applicable entry, rather than replacing it with a date calculated from this table (EMA, question 20).
When the PSUR schedule changes
A new download does not mean every change applies immediately. EMA says changes take effect six months after publication. Exceptionally, another PSUR may be required before the new frequency takes effect, with that requirement indicated in the list. Read the applicable entry and accompanying notes before removing a planned submission. EMA's question 3 explains the transition rule.
The practical difficulty is the intervening report: a less frequent future cycle does not necessarily remove the next filing, so check that point separately from the new frequency. Neither the general six-month rule nor a routine exemption should replace checking an applicable transitional requirement or authority request.
What a PSUSA outcome means for product information
PSURs submitted under the EURD list undergo EU PSUR single assessment, or PSUSA. Possible outcomes are maintenance, variation, suspension or revocation. An assessment does not automatically require a label update. Read the actual outcome and applicable regulatory route before deciding what action follows.
Where variation is required, check the specified amendments to the summary of product characteristics (SmPC) and package leaflet. Article 107g(2) of Directive 2001/83/EC requires an appropriate modification application, including an updated SmPC and package leaflet, within the determined implementation timetable. Apply that duty through the route below. Don't assume every product needs a separate variation application.
The implementation route matters. For centrally authorised products included in the procedure, a Commission decision varies product information without a separate variation. Nationally authorised products included in a Commission-decision procedure need implementing variations. A consensus outcome follows the published timetable for that route. These are distinct routes under EMA's question 30, not one universal implementation deadline.
RegAffairs AI's answer covers how to use the EURD list and what a PSUSA outcome means for product information. It does not replace the current entry or the outcome timetable.
For a product-information change, check the outcome documents for the required amendments and the timetable for your authorisation route.