New Vs Update

The main difference between submitting something as New or as an Update (product or content) is the maintaining of the version history. 

We also want to avoid having duplicate products on the emc; if a New product is submitted that already exists, then our Data Quality team may ask for clarification on why it has been created. 

You may also encounter a prompt if you try to create a Product Group that already exists

If you are submitting something as New you will need to add the reason for submission:

Once a product has been created, or content (such as an SmPC or PIL) is associated to a product for the first time, all submissions thereafter to that product or content should be done as an Update to maintain the history of changes and versions.

The content you associate to a product for the first time will be version 1, and will increase sequentially as you make updates (version 2, version 3, etc).

Document version history, tracking notes and audit logs are all maintained through to product retirement.

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