Before adding documents, you need to CREATE A PRODUCT GROUP
Once your Product Group has been created, you can add your new documents
In this article, you will find information on how to submit the following documents:
- SmPC
- PIL
- RMM
- DHPC
- User Manual
- Safety Alert
- Product Information
- Audio / Video
- Live Chat
Once you have found the information for your specific documents, please see the bottom of this article for information on how to proceed with your overall Product Group submission.
Adding an SmPC
Within the product group, click on the "Content" tab and select "SmPC" (This is the default view when you first enter the product group)
Click "Add SmPC" on the right side of the screen.
Upload your SmPC file. Please also ensure that the document title is unique for the medicine name and strength, as this is how it will appear in the Product Group page for future updates.
An SmPC must be in Word format (.docx file, no larger than 3MB)
Fill in the details on regulator approval and submission details. Then click "Save Changes"
Adding a PIL
Within the product group, click on the "Content" tab and select "PIL"
Click "Add PIL" on the right side of the screen.
Upload your PIL file and fill in the required information. Please also ensure that the document title is unique for the medicine name and strength, as this is how it will appear in the Product Group page for future updates.
A PIL must be in PDF format (.pdf file, no larger than 3MB)
Adding an RMM
Within the product group, click on the "Content" tab and select "RMM"
Click "Add RMM" on the right side of the screen.
You can either upload your RMM file or enter a URL web link. Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
If selecting to submit a document here, an RMM must be in PDF format (.pdf file, no larger than 3MB)
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the RMM link on the emc website), and reasons for submission.
Click "Save Changes"
Adding a DHPC
Within the product group, click on the "Content" tab and select "DHPC"
Click "Add DHPC" on the right side of the screen.
You should upload your DHPC file as a PDF (.pdf file, no larger than 3MB).
Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the DHPC link on the emc website), and reasons for submission.
Click "Save Changes"
Adding a User Manual
Within the product group, click on the "Content" tab and select "User Manual"
Click "Add User Manual" on the right side of the screen.
You should upload your User Manual file as a PDF (.pdf file, no larger than 3MB).
Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the DHPC link on the emc website), and reasons for submission.
Click "Save Changes"
Adding a Safety Alert
A safety alert is a free-text additional tab which can be used to notify HCPs and patients of events such as batch recalls and provides advice for existing stocks.
Within the product group, click on the "Content" tab and select "Safety Alert"
Click "Add Safety Alert" on the right side of the screen.
Enter your safety alert into the free-text box. You have control over what information you would like to include, so long as it is non-promotional.
Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the DHPC link on the emc website), and reasons for submission.
Click "Save Changes"
Adding Product Information
Product Information is a free-text additional tab which can be used to notify HCPs and patients of non-safety related events such as stock updates or upcoming MAH transfers.
Within the product group, click on the "Content" tab and select "Product Information"
Click "Add Product Information" on the right side of the screen.
Enter your product information into the free-text box. You have control over what information you would like to include, so long as it is non-promotional.
Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the DHPC link on the emc website), and reasons for submission.
Click "Save Changes"
Adding Audio / Video
Within the product group, click on the "Content" tab and select "Audio & Video"
Click "Add Media" on the right side of the screen. You can then selected either Audio or Video.
Whether you are adding audio or video, follow the instructions on the pop-up to upload the host link.
Please ensure that the document title is unique, as this is how it will appear in the Product Group page for future updates.
Fill in the required information for audience visibility (self-certification pop-up asking users to confirm they are an HCP prior to viewing the document), content description (this will appear alongside the DHPC link on the emc website), and reasons for submission.
Click "Save Changes"
Adding Live Chat
Live Chat is a free-text additional tab which allows you the ability to provide information on how to access your medicines information web chat facility.
To add a Live Chat tab, please send the following information to servicedesk@datapharm.com
- The text you wish to add.
- URL for Live Chat.
- Is the Live Chat for all products or only selected?
- Should the Live Chat be displayed at all times, or only specific.
Complete Your Submission
Once you have added all of your Documents to your submission, you will be able to see them in Draft status under each document tab within the Product Group.
Next, you can CREATE NEW PRODUCT
Once all of your changes have been made within the product group, click "Continue" in the bottom-right.
Check that all the information on the summary page is correct and add any additional information you would like our QC team to see.
Confirm that you wish to proceed and click "Submit" in the bottom-right.
Your submission will be marked as "In Progress" on the Submissions page and will go through to our Quality Control checks before either returning to you for final approval or, in the case of PILs that have been pre-approved at the point of submission, being published on the emc website.
Please Note 📝
We recommend uploading your documents first as these can then be associated to the product when you go to create it next.
If you create a product without associating content, it can only be saved as a draft. Once you associate a document, you will be able to submit it to our Data Quality team.