In the new emc publishing tool you can create a Product Group and then Products, to save as draft. These cannot be submitted to our Data Quality team or published on the emc without having at least, either a PIL or an SmPC associated to them.
For help creating a new Product Group or adding new Products, please see the following pages for help with these actions:
'How do I add or update a Product Group?'
'How do I add or update a Product?'
Below are the steps for associating content to a product for the first time; If you wish to update content that is already associated to a product, please visit the below help page:
'How do I add or update content?'
To associate content to a product for the first time, find the relevant product in your 'Submissions' page and click on the details icon located to the right of that product information table
You may see a pop-up to add an SmPC which you can select 'Get Started' if you wish to add an SmPC
If you close this pop-up you can still add an SmPC using the 'Add SmPC' button on the right-hand side of the Product Group Management screen you have gone into
If you wish to associate a PIL, simply select the 'PIL' tab
Then 'Add PIL' which is located to the right of that screen
You will be taken through an upload screen for the content, giving criteria for the document type
An SmPC must be in word format (docx file no bigger than 3MB)
A PIL must be in PDF format (PDF file no bigger than 3MB)
A content ID will automatically generated in the file name, but you can change this if you wish to by clicking in the box and editing the text
Complete the required information that is now needed, such as date of first authorisation and reason for submission and click 'Save changes'
If you need to, you can remove the document and replace it by selecting 'Remove' then re-adding the correct document
Once your content is uploaded and showing in the product group management page, you will need to associate it to products.
To do this, select 'Update' on the relevant product that is in your product group management page, then go into the 'Associated content' tab at the top of that page
You can then select the content you wish to associate with that product
Select 'Save changes'
You should now see that your product has a 'Linked PIL' or 'Linked SmPC' showing
When you have added all the content you wish to, have associated the content to products and have provided all the required information, select 'Continue' at the bottom right of the screen to proceed to the Submission Summary page.
Review your submission, confirm your selection
Then press 'Submit' to send off your submission to our Data Quality team
Your submission will be marked as 'In Progress' in your submissions page
You will be notified when this comes back for your final review and approval to publish on emc, or if it needs further information and is marked as 'Needs Attention'
If you have questions please contact us at servicedesk@datapharm.com