Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the applications for marketing authorization for “Established Medicines” to assist the agency in assessing their applications efficiently and to provide smoother and shorter approval process timelines.
The key changes implemented in the guidance are that MHRA will not process the incomplete applications and only one Request for Further Information (RFI) will be sent out to the agency. Besides, applicants are required to submit a template pre-populated with the Lay Summary for the UK Public Assessment Report (UKPAR) upon approval.
MHRA provided 2 approaches for the applicants which are:
Revised process for applications received but assessment has not started
Revised process for applications under assessment or have received a “Request for Further Information”.
Revised process for applications received but assessment has not started
MHRA will notify the applicants two weeks before the assessment commences via email and applications are required to submit:
Marked-up comparison of the Summary of Product Characteristics (SmPC)
Text comparison between the Patient Information Leaflet (PIL) with the equivalent product information for the reference medicinal product
Additional supportive generated stability data for the shelf-life period since the original submission and updated documents to reflect the data
Revised process for applications under assessment or have received “Request for Further Information”
MHRA will limit the applications to another final RFI, and MHRA will refer the application to the CHM if no response or incomplete response is received within the 60-day timeframe, for advice on refusal. The decision on approval or refusal will be made upon the assessment of the final RFI response.
Following the assessment decision to approve, applicants are required to provide a template prepopulated with the Lay Summary for the UK Public Assessment Report (UKPAR) and MHRA will complete the UKPAR draft before published on the MHRA product website.
Contact us at info@arqon.com for more information.