From 13 June 2016 all periodic safety update reports (“PSURs”) for human medicines must be submitted directly to the PSUR repository (“the Repository”).
Prior to submission of a PSUR report to the Repository, marketing authorisation holders are required to check that the information concerning their medicinal products included in the PSUR is correctly entered in the Article 57 database. The database was established based on the legal requirement introduced in Article 57.2 of Regulation (EC) 726/2004 as amended by the provisions of Regulation (EU) No 1235/2010 and Regulation (EU) No 1027/2012. It includes the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling of medicinal products.
Submission of PSUR reports
Submission of PSUR report starts by registering online.
PSUR reports are required to be submitted electronically, using the eSubmission Gateway or Web Client. Submission to the Repository has to be done either by Electric Common Technical Document (“eCTD”) or a non-eCTD electric submission (“Nees”). Other forms of submission will not be possible or will be rejected. Guidance, interactive training sessions and links to relevant documents relating to the use of PSUR repository have been made available on EMA’s eSubmission website.
The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the European Union (“EU”). It was introduced by the EU pharmacovigilance legislation to facilitate the exchange of information on the safety of authorised medicines between regulators and pharmaceutical companies.
PSUR repository also includes the Article 57 submissions database, however if the product has not been correctly submitted to the Article 57 database, it will not be displayed in the Repository.
PSUR reports which have not been submitted to the Repository after 13 June 2016, will be considered as not submitted and therefor will not be assessed.
For technical help or other related questions EMA recommends contacting the EMA Service Desk portal.