As a marketing authorisation holder you are responsible for compiling periodic safety update reports (PSURs). You must do this periodically or submit one at the request of the competent authority.
A PSUR is a periodic safety update report which is sent at predefined intervals to all Member States where the veterinary medicinal product has been given marketing authorisation.
As a marketing authorisation holder you must also provide information on whether any new information has become available that could influence the established safety of the veterinary medicinal product.
At European level, legislation and guidelines specify how a PSUR should be drawn up. The responsibilities and tasks of the marketing authorisation holder and the national authority are also stipulated in these. You should submit the PSUR in accordance with Volume 9B of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Veterinary Medicinal Products.
It is possible that on the basis of information contained in the PSUR a product may need to be modified, for example by the inclusion of an extra warning in the SPC. To effectuate this change, you as the marketing authorisation holder should submit a request for changes. The RMS will coordinate changes in products that are registered in accordance with the MRP or DCP.
Submitting a PSUR
A PSUR can be submitted as part of an application for a renewal, or as an independent submission.
You should preferably use CESP to deliver your PSUR. If you do not have access to CESP, you can submit the PSUR by means of Eudralink. Mail this Eudralink to email@example.com
Do not on any account submit PSURs by post.
On submission, your PSUR must be accompanied by a cover letter. In the cover letter please clearly state the Product type of your PSUR.
If the PSUR concerns Worksharing, this must be clearly stated in the cover letter. In addition, the required information as described under PSUR Worksharing must be added.
If you still have questions about the submission of PSURs please contact us via firstname.lastname@example.org.