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

How do I add or update a product?

All of your published products will be visible to view in your 'All Products' page from the left-side menu 

 

Update an existing product:

To update one of your published products, find the one you wish to update in your 'All Products' page and select the 'Update' button on the right of that product listing

 

You will now be in that products own 'Product Group Management' page

 

To update the product details, click on the 'Update' button of the product you wish to edit; from here you can make changes to your product as needed, such as updating the MA number, legal category, allergens, ATC code or black triangle status in the 'Product Details' tab. 

 

Select 'Save Changes' once you have edited all you need to at this current time, or select 'cancel' to erase the changes you have made.

 

 

Once you have saved your changes your product status will change to 'Draft'; you can continue to submit this change for Data Quality review or you can leave it as draft and come back to it later to submit/continue editing the product.

 

Please Note 📝

To undo the changes you have made by selecting 'Remove' and then 'Confirm'

 

When you are ready to submit your changes to Data Quality for review, select continue.

 

Review your changes in the submission summary page and confirm your selection

 

Click 'Submit' if you wish to submit to Data Quality for review.

 

This updated product will now be showing as 'In Progress' in your submissions page

This product update will be reviewed by our Data Quality team and will be sent back to you as either 'Ready for Approval' (ready for your final review and publishing) or 'Needs Attention' (there may be further information required). 

 

Add a Product:

You can add products to your portfolio in two different ways;

Create a new Product Group:

If you need to create a new product group, please refer to this help page to take through how to do that - 'How do I add or update a Product Group?'

 

Add Products to an existing Product Group:

To add a new product to an existing product group, find one of the products that belongs to that group in your in your 'All Products' page and select the 'Update' button on the right of that product listing

 

You will now be in that products own 'Product Group Management' page

 

From here you can create more products in this group by clicking on the 'Add Product' button located to the right, just above the products you already have listed there

 

Add all of the required information to create the new product as prompted such as the product form and strength

 

Once you have created the basic product information you will be able to save as draft to come back to another time if you need to, or you can continue adding more of the relevant information such as product details (legal category, black triangle, etc).

 

You can also associate content such as SmPC's or PILS, this can be done now or later if you choose save your progress so far as a draft.

When you want to associate content, you can associate content that you have available to select because you uploaded it already; this will be showing as an available option to select in the 'Associated Content' tab.

Alternatively you can add new content such as uploading an SmPC or PIL; this can be uploaded from the 'Product Group Management' page, selecting either 'Add SmPC' or 'Add PIL'.

     

 

For help adding and associating content to your products, please see the below help pages:

'How do I associate content to a product?'

'How do I add or update content?'

 

Once you have added all of the product information click 'Save Changes'

 

This new product will now be in a draft status.

You can delete this draft product at any time by selecting 'Remove' 

 

Once all required information is entered and content is associated, you can press 'Continue' to go to the submission summary page 

 

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

 

Review your changes in the submission summary page and confirm your selection

 

Click 'Submit' if you wish to submit to Data Quality for review.

 

This updated product will now be showing as 'In Progress' in your submissions page

This product update will be reviewed by our Data Quality team and will be sent back to you as either 'Ready for Approval' (ready for your final review and publishing) or 'Needs Attention' (there may be further information required). 

 

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