PSUR worksharing

The PSUR Worksharing project was initiated by the Heads of Medicines Agencies (HMA).

The concept of the PSUR Worksharing project is that all veterinary medicinal products with the same active ingredient (or a fixed combination of active ingredients), may maintain the same Data Lock Point for the compilation of PSURs.  This makes it possible for you, as the marketing authorisation holder, to follow the same PSUR submission procedure in all the countries of Europe.

This project offers the authorities the opportunity to use the assessment capacity more efficiently by having the assessments carried out primarily by one country and then sharing the resulting data and recommendations.  This country is then the P-RMS (PSUR Reference Member State) for that particular active ingredient and the relevant PSURs.

Currently, the implementation of the recommendations included in the PSUR assessment, e.g. modifications to the SPC, is still a national task.  It can be assumed that the RMS will accept and implement the recommendations concerning those substances that are authorised in accordance with the MRP or DCP.

Participation in the PSUR Worksharing project

All the information about this project has been published on the website of the Heads of Medicines Agencies under Periodic Safety Update Reporting (PSUR) – Synchronisation and Worksharing.

Amongst others, the following documents have been published here:

  • List of active substances, firm designated as the originator, EU Harmonised Birth Dates, Data Lock-in Points and P-RMS
  • PSUR Worksharing Q&A for Marketing Authorisation Holders
  • Information sheet for Marketing Authorisation Holders: The Core Safety Data Sheet

As a marketing authorisation holder you are requested to consult these documents.  These documents explain how to submit a PSUR.  They also explain how a PSUR is assessed in a Worksharing procedure.  These documents are regularly updated.

In the cover letter to the PSUR, you must clearly state that the PSUR is being submitted as part of the PSUR Worksharing project and also state the PSUR WS reference number (Code: WS PSUR <substance> <year (DLP)> <P-RMS).

You should also submit a table (in Word format) containing an overview of the following:

  • The Member States in which the product has been approved
  • Product name, pharmaceutical form(s) and strength(s)
  • Registration numbers.  If the product has been approved via an MRP or DCP, you should add the MRP or DCP numbers
  • 1 staff contact per firm, including the email address for the procedure in all EU member states.

You should also include a Core Safety Data Sheet (CSDS) with the PSUR submission.

It is possible that a PSUR could be submitted as part of the PSUR Worksharing procedure while at the same time it is also part of an application for re-registration or renewal of a registration.  In this case, as a marketing authorisation holder, you are requested to only submit the PSUR with the Worksharing, and, in the cover letter with the application for re-registration/renewal of a registration, to state that the PSUR has been submitted separately (with a cross-reference).  The PSUR does not have to submitted in duplicate, but only with the PSUR Worksharing.

For practical purposes, the rules and delivery addresses for these PSURs are the same as for the other PSURs.