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Periodic Safety Update Reports

  • Published: January 29, 2021
  • Last updated: January 27, 2022

Periodic Safety Update Reports (PSURs) are reports on the benefit-risk balance for a medicinal product, which are submitted to the medicinal product authorities. The reports contain information on the product, both for its authorised use and for uses outside the authorised indication.

The reports differ to some extent, depending on whether the medicinal product is intended for human or animal use.

The reports, known as Periodic Safety Update Reports (PSURs), are submitted on specific occasions after a medicinal product has been authorised, regardless of whether or not it is being marketed.

The authorities use the information to identify new risks and assess whether the benefit-risk balance has altered. If there are grounds to do so, the authorities will initiate further investigations or measures to minimise the risks associated with use.

Medicinal products for human use

The EURD list

The European Medicines Agency (EMA) is responsible for a list of active substances and combinations of active substances present in medicines authorised in the EU.

The list is known as the ‘List of European Union reference dates and frequency of submission of periodic safety update reports’, abbreviated to ‘the EURD list’.

It specifies the reference date and frequency for the submission of periodic safety updates.

Information concerning a particular substance or combination of substances takes effect 6 months after the date of publication in the list.

The appointed rapporteur in the EURD list prepares a scientific assessment report, known as a Single Assessment Report, which presents a joint assessment of the submitted PSURs.

All periodic safety updates (PSUSA) are handled via what is known as a PSUSA (Periodic Safety Update Single Assessment) procedure. A fee is charged by the EMA for products which are included in a PSUSA.

The Marketing Authorisation Holder (MAH):

  • Is obliged to submit a PSUR as follows:
    • if the substance or combination of substances is included in the EURD list, the PSUR frequency and DLP must be followed. The EURD list overrides the PSUR frequency and the DLP described in Article 107c(2) of Directive 2010/84/EU, as well as other conditions stipulated in the marketing authorisation.
  • If the substance/combination of substances is not included in the EURD list, a PSUR must be submitted:
    • every 6 months after the marketing authorisation was approved in Sweden and the product marketed.
    • every 6 months for the first two years after the product was first marketed.
    • annually for the next two years.
    • then at three-yearly intervals.
  • Is not obliged to submit a PSUR for products authorised as:
    • generic medicines.
    • homoeopathic medicinal products.
    • traditional herbal medicinal products.
    • medicinal products authorised via well-established medicinal use (bibliographical application).

if it is not specified as a condition for the marketing authorisation or in the EURD list.

How should periodic safety update reports be submitted?

  • PSUR Repository is a central platform for the storage and exchange of PSURs and related documents between regulatory authorities and pharmaceutical companies within the EU.
  • It is mandatory to submit the reports via this platform, submissions are made via
  • The MAH must register as a user on eSubmission registration.
  • The MAH must ensure that the information provided concerning authorised products in the Article 57 database is accurate; if it is not, the PSUR cannot be uploaded.

The platform is based on the pharmacovigilance legislation in order to facilitate the exchange of information between regulatory authorities and pharmaceutical companies. PSUR Repository is only used for medicines intended for human use.

The EMA is responsible for PSUR Repository and eSubmission Gateway/Web Client, and questions can be answered by the EMA Service Desk portal.

Outcomes following assessment of periodic safety update reports

The MAH must keep itself up-to-date concerning substances which concern its products, and ensure that the summary of product characteristics (SPC) is also kept up-to-date.

This also applies in cases where the routine submission of PSURs is not required, e.g. in the case of generics.

This includes updates in accordance with the outcome of PSUR assessments.

  • Outcomes following PSUR Single Assessment Procedures are published on the EMA’s website.
  • Findings following a national PSUR investigation are communicated to the MAH by the MPA.
  • Outcomes following a PSUR Work sharing procedure are published on the CMDh’s website.

Medicinal products for animal use

With the New Veterinary Regulation (EU) 2019/6, PSURs are no longer required for veterinary medicinal products. No submissions of PSURs for veterinary medicinal products should take place after the 27th of January 2022. The last data lock point for veterinary PSURs falls on 28th of November 2021.

The CVMP has endorsed transitional arrangement measures for the time period between the last PSUR DLP and 28 January 2022, where potentially non‐serious adverse event reports fall short of the normal regulatory surveillance. This is further described in the document published on the HMA website:

The new signal management procedures replacing the veterinary PSURs are still under preparation.

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