Further to the nomenclature harmonisation in 2003/04 Changes to medicines names: BANs to rINNs, the European Pharmacopoeia and British Pharmacopoeia have amended the spelling of sulphate to sulfate for all products containing sulfate (or sulfur containing compounds eg sulfonate). This amendment is in-line with both ICH nomenclature and that used by the World Health Organisation’s International Non-proprietary Name programme, naming of radicals and groups. Subsequently the BNF has amended the spelling of sulphate to sulfate.

 

Marketing authorisation holders (MAH) are now required to amend the spelling of -sulph- to -sulf- on all product information for sulfur and sulfate containing compounds. This change may be considered a Type I A variation (change code A.3 – requires immediate notification post implementation), which is not chargeable in the UK, but may be in other Member States if the change also applies to any European procedure.

 

The changes must be made to existing marketing authorisations for any affected active pharmaceutical ingredients and excipients before 1 January 2016.

 

Any questions regarding this may be sent to variationqueries@mhra.gsi.gov.uk.

 

Posted on the UK MHRA website on 1 May 2013