The NHSBSA needs to check your submission and so requires an updated SmPC that reflects the product or pack changes.
If you are an emc Data Manager, med data dm+d links directly to the emc and so SmPCs that are published on the website can be attached to your submission.
To find your SmPC:
- Click the company you are representing from the drop down list. You will see a list of SmPCs from the emc that are live on the website,
- Click the hyperlink on the product name to preview the SmPC,
- Find the correct SmPC using 1, 2, etc. to move through the list,
- Click Attach.
If your SmPC is not yet published on the emc, attach the SmPC in either Word or PDF format.
Once an SmPC is attached, you can view and change the SmPC that you have selected.
If you are not an emc Data Manager, use the Browse option to locate and attach your SmPC in either Word or PDF format from your PC or network.
Please note 📝
Once an SmPC has been attached, a copy is made and stored on a Datapharm server.
The SmPC can be viewed by the NHSBSA but is not sent to them. If you subsequently update the SmPC on the emc site, the med data dm+d submission will still have a copy of the original SmPC attached. It is not automatically updated, but you will be alerted.
To attach the new version of the SmPC you will need to cancel your submission, copy it, and then attach the new version of your SmPC.