Using the EURD List

If your active substance is on the EURD list, your deadline is the Submission date in its row. The EU calls that date "legally binding and must be adhered to". If the substance isn't on the list, the deadline comes from your marketing authorisation, or failing that from the standard schedule in the Directive. Either way, it is counted in calendar days from the data lock point (DLP).

Approach: Our datasets don't set out PSUR deadline rules. They hold only EMA's PSUSA outcomes register and Belgian FAMHP guidance, which says only that MAHs must submit PSURs regularly. So I used EMA's PSUR page, the EURD list cover note (EMA/606369/2012 Rev.17) and GVP Module VII (EMA/816292/2011 Rev 1, effective 13 December 2013 for DLPs after 12 December 2013).

1. Your substance is on the EURD list (the usual case)

1. Download the current list. It's an Excel file on EMA's PSUR page.
2. Find the entry that is most specific to your product. That means the right salt, scope in brackets, or fixed-dose combination.
3. Read three columns: the frequency, the DLP and the Submission date.
   • The cover note says the submission date "is the deadline that must be followed by the MAHs".
   • It is set "according to the timelines defined in GVP Module VII, Section A".
4. Check the "Next DLP" and "Next Submission Date" columns if the substance has a PSUR frequency of up to 6 months. They show your following deadline too.
5. Check the Notes column for ad hoc PSUR requests. These can apply before a frequency change takes effect.

GVP Module VII says the DLPs in the list "are fixed on a certain date of the month, and should be used to determine the submission date (which has legal status)".

2. How the date is calculated

GVP Module VII.A says PSURs should be submitted:

• within 70 calendar days of the DLP (day 0) for intervals up to 12 months, including exactly 12 months;
• within 90 calendar days of the DLP for intervals of more than 12 months;
• for ad hoc PSURs requested by a competent authority: within the timeline in the request. If the request gives none, within 90 calendar days of the DLP.

EMA's PSUR page repeats these timelines and states that the deadline "is published in the EURD list".

3. Your substance is not on the list

GVP Module VII.C.3.3.1 says such PSURs "shall be submitted according to the PSUR frequency defined in the marketing authorisation". If the MA doesn't specify one, you follow the standard schedule (Directive Art 107c(2) and Regulation Art 28(2)).

GVP VII.C.2 sets out that standard schedule for products authorised before 2 July 2012 (centrally authorised) or 21 July 2012 (nationally authorised):

• every 6 months once authorised, even if not marketed;
• after first placing on the EU market: every 6 months for 2 years, then yearly for 2 years, then every 3 years.

Then apply the 70/90-day timelines above to each DLP.

Things that change the date

• Changes take effect 6 months after publication. This applies to a frequency or submission date published in the list (Art 107c(7)).
• Generic, well-established use, traditional herbal and homeopathic products don't have a deadline unless the list's Yes/No column requires PSURs, or the MA or an authority does.
• Authorities can still ask at any time. National authorities and EMA can request a PSUR whenever they choose, with their own deadline.
• Submit through the PSUR Repository, quoting the PSUSA/xxxxxxxx/YYYYMM number. The YYYYMM part is the DLP month.

Sources:

• EMA: Periodic safety update reports (PSURs)
• EMA: Introductory cover note to the EURD list (EMA/606369/2012 Rev.17)
• EMA: GVP Module VII – Periodic safety update report (Rev 1)

A PSUSA outcome tells you whether your SmPC and package leaflet must change. Maintenance means no change: the procedure ends with the PRAC recommendation. Variation means you must make specific changes to the product information. Suspension (or revocation) means the marketing authorisation itself is affected. EMA says the outcome is a legally binding decision or CMDh position, and any action "must be implemented in a harmonised and timely manner for all products within the scope of the procedure across the EU".

Approach: I checked EMA's PSUSA outcomes register for how outcomes are recorded. It gives only the outcome label, so the implementation rules come from EMA's PSUR Q&A page (the implementation question was last revised 6 October 2026) and one example CMDh outcome document.

What each outcome means for your product information

Outcome	Product information	What happens next
Maintenance (e.g. landiolol, PSUSA/00010570/202302 [1])	No change	The recommendation is not sent to the CHMP or CMDh. The procedure ends when PRAC adopts it.
Variation (674 outcomes in the register)	Changes to specific sections, with exact wording	CHMP opinion if at least one centrally authorised product (CAP) is involved, or CMDh position if only nationally authorised products (NAPs). The CHMP route, and the CMDh route when reached by majority vote, are followed by a Commission Decision.
Suspension (one in the register: hydroxyethyl starch, EMEA/H/N/PSR/J/0031 [2])	The marketing authorisation is suspended	Same CHMP/CMDh route. EMA's page also lists revocation as a possible outcome.

What a variation outcome contains

The CMDh annexes for levosimendan (PSUSA00001858202409 ^[3]) are a typical example:

• Annex I, scientific conclusions: PRAC considered a causal link with hypersensitivity "at least a reasonable possibility". The CMDh found the benefit-risk balance "unchanged subject to the proposed changes to the product information".
• Annex II, the amendments: the exact wording to add (underlined and bold) or delete (struck through). Here, "Hypersensitivity" with frequency "not known" is added to SmPC section 4.8 and package leaflet section 4.
• Annex III, the timetable: CMDh position adopted May 2025, translations sent to national authorities 6 July 2025, MAH variations to be submitted by 4 September 2025.

How you implement it

Your product was in the procedure

• CAP: the product information "is varied as part of the Commission Decision issued to the MAHs, without the need for a variation". You should submit clean and tracked versions of the agreed product information before PRAC adopts its recommendation.
• NAP, CMDh consensus: submit the variation by the date in the timetable. That is 105 calendar days after the position (45 days to publish the translations plus 60 days after that). The timetable applies to all affected products, including those not listed in the annex.
• NAP, CMDh majority vote or CHMP opinion: submit within 10 days after the Commission Decision is published on the EC website. National authorities implement the decision within 30 days of notification.

Your product was not in the procedure

• CAP (e.g. a generic): submit within two months of receiving EMA's communication. Use type IA_IN C.3.a if you use the agreed wording exactly and harmonised national translations exist. Otherwise use type IB C.3.b.
• NAP: submit by the same 105-day timetable for a consensus position, or within 60 days of publication of the Commission Decision for a majority position or CHMP opinion. CMDh Variations Q&A 3.3 covers the variation type.
• Any product: if you want to submit new data for assessment, use a type II variation.

Products outside the substance's EURD entry: the recommendation applies directly only to products within the scope of that EURD entry. Other MAHs still have to keep their product information up to date. They should consider whether the outcome is relevant to them and vary if so, even if PRAC did not ask for that (Q31, new March 2026). In exceptional cases PRAC extends a recommendation itself, for example from a single substance to its fixed-dose combinations. EMA then contacts the affected CAP holders, and requests for NAPs are published in the CMDh minutes.

Translations

After a variation outcome you translate the adopted annexes into all EU languages, plus Icelandic and Norwegian where you hold authorisations there. EMA advises preparing straight after the PRAC recommendation.

• CHMP opinion or CMDh majority: translations due Day 5, Member State comments Day 19, final versions Day 25.
• CMDh consensus: translations due Day 15, final versions Days 28-34.

The translations must follow the English annex structure exactly and use the QRD templates.

Where outcomes are published

• CAP-only procedures: the medicine's EPAR page.
• NAPs in mixed procedures: the Union Register.
• NAP-only procedures: EMA's Download medicine data page.

Any follow-up data PRAC requests is submitted as a LEG (CAPs) or a PSUFU (NAPs), not through the PSUR Repository.

Sources:

• EMA: Periodic safety update reports (PSURs), Q&A 25-31
• EMA PSUSA page: levosimendan PSUSA00001858202409
• CMDh scientific conclusions, product information amendments and implementation timetable: levosimendan