How to name 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 SPC or PIL/X-PIL. DMS does not automatically take the information from section 1 of your SPC.


For both PILs and SPCs, use the document title (including strength) given in section 1 of the SPC. If the product name on the SPC and PIL differ, use the SPC name as the definitive name for both documents. X-PILs will automatically have the same name as the PIL.


The only exception is for PILs with different legal categories but the same marketing authorisation number – see below.


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


Some SPCs 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For an unpublished SPC or PDF PIL/X-PIL, from the document tasks menu, select the option to 'change document details'.


For a published SPC or PIL (with or without an X-PIL), 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.


Preventing duplicate names


DMS will not allow you to publish more than one SPC with the same name, or more than one PIL/X-PIL with the exact 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