MHRA: Safety Updates Will No Longer be Submitted to National EU Regulators Beginning in June
Posted 19 February 2016 | By
From 13 June 2016 onward, companies across Europe will no longer submit periodic safety update reports (PSUR) to national regulators but instead to a central repository at the European Medicines Agency (EMA).
The repository was created under legislation introduced in July 2012 and also provides for the storage of associated assessment reports, additional data and comments.
“This will apply for all products including those only approved in the UK. From 13 June 2016 there will no longer be submission of PSURs to the MHRA [Medicines and Healthcare products Regulatory Agency] or any other national competent authority,” UK’s regulator said in an update Thursday.
The repository, which is now accepting PSURs, or what in the UK are called periodic benefit risk evaluation reports (PBRER). Use will be mandatory from 13 June, even if the product is only authorized in the UK. But up until that date, companies should also submit PSURs to the MHRA using current procedures, the regulator said.
PSUR submissions to the repository, a new version of which went live in January, will be made using the eSubmission Gateway/Web Client with an additional XML delivery file included in the submission package, according to the EMA. The agency has developed a user interface for the creation of the delivery file.
“When a submission to the PSUR Repository is made using the XML delivery file, the use of the manual file naming convention to provide the metadata, is no longer obligatory,” EMA says. “The XML delivery file must be provided within the submission package (i.e. in the relevant ZIP file). The agency encourages applicants to use guidance provided in Annex 3 of the PSUR filenames for repository submissions when using the XML approach.”
Centrally authorized medicines submissions to the PSUR repository is already mandatory, EMA noted.
Updated MHRA guidance on periodic benefit risk evaluation reports for medicinal products