1. New emc regulatory publishing tool
  2. How do I use the emc regulatory publishing tool?

Save as Draft

The emc regulatory publishing tool allows you to create submissions and save your progress as a draft at any point. This can be useful if you only have some of the required information, or if you wish to create a Product Group and/or a Product ahead of time, e.g creating a new product ahead of a launch, but not submitting it just yet as you are awaiting final approval, either internally or from the regulatory body (MHRA). 

 

Draft submissions are shown in the 'Submissions' page, with the status column showing as 'Draft'

 

To continue editing a draft submission, simply click on the details icon to go into it and make any changes as needed

 

After making any changes, remember to click 'save changes' to save your progress or 'cancel' to erase them

 

You can edit a draft submission as many times as you need to, before submitting it for Data Quality review

 

Please Note 📝

A product cannot be submitted for Data Quality review without having either a PIL or an SmPC associated to it.

You will be shown the following alert if you try to submit a product without the required content

 

If you have any questions please contact us servicedesk@datapharm.com