Variation submission to MHRA – Getting it right the first time!

The submission of a variation application always leads to the possibility of validation issues or Notification with Ground (NWG) letter.

Validation issues can appear in many situations, from missing SmPC fragments (31%) to incorrect variation code (8%).

The most common was the absence of proof of payment (32%), which will not happen anymore with the introduction of the invoice payment since 1st April.

Regarding generation of NWG letters, the MHRA estimate that more than 75% of applications for type IB or II variations do not contain all the necessary data for a full assessment. Generation of NWG letters is time consuming for the MAH and variations team, and may add 30 to 60 days to the expected assessment timeframe.

In order to improve the quality of submissions and reduce delays, the MHRA has already implemented some changes as fee calculators, paperless communication or invoice payment. They also included advice on how to avoid common deficiencies in a submission dossier during symposiums and workshops, and will continue that way for future events.

Articles are also expected to be posted on the MHRA blog. Regulis will share with you any new information that can help you reduce approval time for your submissions.

Clear here to access the article on the MHRA blog.