Getting it Right the First Time

When updating product licence details, there are always areas in the variation submission processes which can cause validation issues or the generation of Notification with Grounds (NWG) letters, ultimately resulting in a rejection or delay.  These can be time consuming for the MAH (Marketing Authorisation Holder) and may impact on assessment timeframes.

Learn about the key themes and "show stoppers" which have emerged over the last 5 years in this post by the Medicines and Healthcare Products Regulatory Agency.

https://medregs.blog.gov.uk/2017/04/21/getting-it-right-first-time/

Source: https://medregs.blog.gov.uk/2017/04/21/getting-it-right-first-time/