MHRA’s New Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.
The purpose of this guideline is to provide industry with clear guidance on the factors which need to be considered when selecting or constructing a product name. Notwithstanding the guidance provided, applicants should take into account the principles contained within the Best Practice Guidance on the Labelling and Packaging of Medicines, including prominent display of the active ingredient(s) and pack design/graphics clearly differentiating products and should conform to the requirements of Directive 2001/83/EC.
The MHRA does not comment on issues arising from protection or infringement of trademarks. This guideline does not contain any new legislation or requirements but consolidates all current requirements into a single document, giving specific examples where appropriate, to aid applicants when selecting a product name.
The Licensing Authority may reject a name if it considers that, on the information given, or in its own assessment, the name will cause confusion with the name of an existing medicine, is misleading as to the composition of the product or the use, or is otherwise unsafe.
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