EURD list: list of Union reference dates and PSUR frequencies
The EURD list sets the Union reference date, data lock points and PSUR submission frequency for each active substance authorised in the EU.
The list of European Union reference dates and frequency of submission of periodic safety update reports is provided for in Article 107c(7) of Directive 2001/83/EC and Article 28a of Regulation (EC) No 726/2004. EMA publishes it after the CHMP and CMDh have agreed it on the basis of PRAC advice, and updates it roughly monthly. For each active substance or combination it gives the Union reference date, the frequency of PSURs, the next data lock point and submission deadline, and the procedure number of the PSUR single assessment that will cover the substance.
The list overrides the PSUR schedule set in individual marketing authorisations. Every holder of a product containing the substance must submit a PSUR for the same data lock point, which is what makes the single assessment possible. Generic, well-established use, homeopathic and traditional herbal products are exempt from routine PSURs under Article 107b(3) unless the list specifies that they must submit, which it does where a substance needs the extra data. The list also notes where a PSUR is not required at all.
Holders need to watch the list rather than their own calendars. A substance can be added when a product is authorised, a frequency can be shortened after a safety issue or lengthened after a few uneventful cycles, and a data lock point can move. Requests to change an entry can come from holders, with justification, or from authorities, and the changes take effect six months after publication so that holders can prepare. The entry also states whether generic holders are included.
What goes wrong: a PSUR planned to the frequency in the authorisation rather than the current list; a data lock point missed because the list changed and nobody picked it up; and a generic holder assuming exemption when the list says otherwise. Mergers and transfers are a frequent source of error, because the new holder inherits products whose EURD entries were never mapped.
Under the new pharma package (not yet in force), the default PSUR cycle for authorisations without a set frequency becomes yearly for five years, three-yearly for six, then five-yearly, and changes to the list take effect after four months; see PSUR changes.
Timing
The list is updated about once a month. A new or changed entry applies six months after publication, so a holder whose frequency changes has that long to prepare the next report. The PSUR itself is due within 70 days of the data lock point for reports covering up to 12 months and within 90 days for longer intervals, and the submission deadline for each data lock point is printed in the list.
Used in
Pharmacovigilance and regulatory teams map every product to its EURD entry and plan the resulting PSUR deadlines in the lifecycle planning workflow.
Related terms
- PSUR: periodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.
- PSUSA: PSUR single assessmentA PSUSA is the single EU assessment of all periodic safety update reports for one active substance, led by the PRAC and binding on every holder.
- PRAC: Pharmacovigilance Risk Assessment CommitteeThe PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.
- Generic application: abridged application under Article 10(1)A generic application under Article 10(1) of Directive 2001/83/EC authorises a copy of a reference product by relying on that product's data.
- WEU: well-established useWell-established use (WEU) is an application route that shows efficacy and safety through published literature instead of the applicant's own studies.
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