The MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly.
The name must also comply with legislative requirements and the MHRA has issued naming policy guidance with respect to invented names and qualifiers, umbrella segments, generic nomenclature and Braille requirements for product names.
The guidance document incorporates aspects of the MHRA naming policy for invented names including, but not limited to, the construction of pharmaceutical trademarks, similarity of invented names to existing International Non-proprietary Names (INNs), use of suffixes for modified release preparations and use of umbrella branding.
The guidance document consolidates MHRA policy on the naming of medicines and it is intended to provide detailed information and clarity of advice to applicants on the criteria applied by the MHRA when reviewing the acceptability of proposed names for medicinal products.
This is the first publication of the guideline which will be a live document that will continue to evolve in future revisions. Should you have any questions relating to the naming of medicines or the guideline please email inventednames@mhra.gsi.gov.uk
MHRA guideline for the naming of medicinal products and braille requirements for name on label
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