e. when your very first application was waiting just after ), it’s also advisable to modify the fresh new relevant inquiries regarding dataset when and make the amendment.

Unlike submitting a first app, there is no procedure to the regulator in order to consult further information (RFI) to own amendments. Yet not, you are contacted of the current email address otherwise cell to include certain information or explanation if this is required in advance of issuing a final viewpoint.

If you are submission a modification getting a venture where the fresh software are waiting prior to , the analysis pointers and CWOW health-related dataset (today also known as ‘Medicines Information’) sections on your opportunity are not over because it are not being used during the time you made the job. Read more