Update on submission requirements and recommendations for PSURs during transitional phase until PSUR repository becomes mandatory

News Category: Regulatory news

Date: 17/02/2016

MAHs are reminded that the use of the EU PSUR Repository will become mandatory for all PSUR submissions as of 13 June 2016. From this date onwards, MAHs will be required to submit PSURs directly to the EMA via the PSUR Repository and there will no longer be any requirement to submit PSURs directly to the HPRA. This will apply to all PSUR submissions i.e. both centrally authorised medicinal products (CAPs) and nationally authorised medicinal products (NAPs).

Although there is no change to the existing submission rules to the HPRA and other national competent authorities during the transitional phase (from now until June 2016) and submission of NAP PSURs (which includes products authorised via MRP/DCP/purely national procedures) to the PSUR repository remains optional, it is strongly recommended that all MAHs take this opportunity to submit their PSURs (as well as supplementary information and responses)  for NAPs to the PSUR repository in addition to the other submission pathways required in order to build experience in the use of the PSUR repository and to incorporate such use into local business processes. Further details of the submission requirements and recommendations for PSUR submissions during the transitional period can be found on our Periodic Safety Update Reports (PSURs) webpage and on the e-submission PSUR repository webpage.


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