The NHSBSA need to check your submission and so require an updated SmPC that reflects the product or pack changes.
If you are an emc Data Manager, in-demand links directly to the electronic Medicines Compendium (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. To preview the SmPC click the hyperlink from the product name.
Find the correct SmPC using 1, 2 etc to move through the list. Then click Attach. The SmPC will then be attached to the submission.
If your SmPC is not yet published on the emc, you should attach an SmPC in either Word or PDF format by browsing your PC or network.
Once an SmPC is attached, you can either View or Change the SmPC that you have selected.
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 in-demand 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.
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.