Submit documents

Difference between new and updated submissions?
Create a new submission if: you have an SPC or PIL that has never been published on emc website before; or you are adding an individual SPC or PIL tha...
Fri, 23 Aug, 2019 at 11:28 AM
File types, sizes and quality
For SPCs, we only accept Word documents. Do not submit SPCs that have track changes, are scanned or are password protected. The Word document can contain ta...
Fri, 23 Aug, 2019 at 11:30 AM
Combined SPCs and PILs
Combined SPCs and PILs/X-PILs are allowed, but please make sure they are named correctly to reflect all medicines. If you have two single documents publ...
Fri, 23 Aug, 2019 at 11:30 AM
Reasons for submission or change
Please tell us the reasons why you are making the new or updated submission. You can add more than one reason, but only one at a time. For SPC updates -...
Fri, 23 Aug, 2019 at 11:31 AM
Change details section (SPC only)
Some emc users need to know exactly what has changed in an updated SPC. For example NHS Medicines Information Pharmacists (UKMi) monitor SPC changes in case...
Fri, 23 Aug, 2019 at 11:32 AM
Fast track documents
We can fast track an SPC, PIL or X-PIL if it needs to be published urgently due to safety or regulatory issues or for a new product launch. Please email det...
Fri, 23 Aug, 2019 at 11:33 AM
Marketing authorisation numbers (PILs only)
For new or updated PILs, please provide the marketing authorisation (MA) number(s). This information can be found in section 8 of your SPC. The MA numbers a...
Fri, 23 Aug, 2019 at 11:33 AM
Alternative text (X-PILs only)
If you request an X-PIL, your PDF PIL will be converted into a text only X-PIL with no graphs, images or tables. We have to remove the graphs, images and ta...
Fri, 23 Aug, 2019 at 11:33 AM