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Naming Documents

 

Product names need to be clear and consistent so that users can find information

The document title that you enter is used in the emc/X-PIL search results and the banner displayed at the top of your SmPC or PIL/X-PIL

emc publisher does not automatically take the information from section 1 of your SmPC

 

Top Tip

For both PILs and SmPCs, use the document title (including strength) given in section 1 of the SmPC

If the product name on the SPC and PIL differ, use the SmPC name as the definitive name for both documents

X-PILs will automatically have the same name as the PIL

 

 

Naming PILs with different legal categories and pack sizes but the same MA number

 

Some SmPCs include products with different legal categories and pack sizes, but only one marketing authorisation (MA) number. For example the same MA number could cover a 12 tablet pack of ibuprofen (GSL), and a 24 tablet pack of ibuprofen (P).

 

To differentiate the presentations, please enter the PIL product name as:

Productname 25mg tablets (12 pack)

Productname 25mg tablets (24 pack)

 

BANs or rINNs?

 

All products should use their Recommended International Non-Proprietary Names (rINNs) rather than their British Approved Names (BANs).

emc search lists display rINNs, apart from adrenaline and noradrenaline which are listed under their BANs.

 

How to change a document title

 

For an unpublished SmPC or PDF PIL/ePIL, from the document tasks menu, select the option to "change document details"

 

For a published SmPC or PIL (with or without an ePIL), choose 'Published' under the My Documents tab, find your document and click on the document title. In the left hand document tasks menu select the option to 'Change Document Title'. Follow the on-screen instructions. You do not have to submit an update just to change the title of a published document.

 

 

 Please Note 📝

emc publisher will not allow you to publish more than one SmPC or PIL/ePIL with the same name.

If you change a product name for an existing product, please be aware that the document history may be lost. Please name your documents carefully