How to upload SmPC

Select Create submission in the top right corner and choose Update a product or Go to All Products from the left side menu, locate the product, and click Update
- You will be taken to the product’s Product Group Management screen.
In the Product group management screen, open the Content tab and select SmPC
Select Add SmPC or Update the new version
Upload your SmPC Word file
- Must be .docx format
- Maximum file size 3MB
- Ensure the document title is unique for the medicine name and strength, as this is how it will appear in the Product Group for future updates.
Complete the fields for Regulator approval and Submission details.
Select Save Changes.
Select the product to associate with the document once it is in Draft status.

For detailed instructions, see How to associate a document/content with a product.
Once the product association is complete, select Continue to proceed and complete the submission.

💡Can multiple content types be uploaded in one submission?

Yes. Multiple content types can be submitted within a single submission, together with the product details, provided the product has at least one associated SmPC and/or PIL that is either already published or included as part of the same submission.