elizabeth. should your very first application was waiting just after ), you should also update the new corresponding issues in the dataset whenever and work out the modification.

Rather than entry a first application, there’s no processes towards the regulator so you can demand more information (RFI) to own amendments. not, you might be contacted of the current email address otherwise telephone to include specific information or clarification if this sounds like requisite ahead of providing a last advice.

When you are submitting a modification to possess a job the spot where the amazing software are prepared just before , the analysis suggestions and you will CWOW health-related dataset (today described as ‘Medicines Information’) areas on your own venture may not be done because it try not being used at the time you have made your application. Yet not, to help you proceed to would and complete an amendment the opportunity dataset must be verified of the system given that done.

The latest confirmation was turned off for those concern modules, until you push conserve towards the bottom of every webpage. We recommend that you never mouse click some of these empty issues or push save’ as the this will activate verification and you will mean that your do not go-ahead with your amendment if you do not have finished the complete dataset.

Reporting

If any most other report versions apply at assembling your project which can be not in the list above, these might be waiting and you can recorded outside the system since the specified from the related comment body/regulators.