The scope of this Guideline is to provide information on the overall procedure for submitting and reviewing the acceptability of proposed (invented) names for human medicinal products processed through the centralised procedure, as well as detailed guidance on the criteria applied by the Name Review Group (NRG) when reviewing the acceptability of names.
The NRG Group
The NRG Group is dedicated to the evaluation of trade names of medicinal products reviewed by EMA and aims to consider whether the manufacturer’s proposed name may create health risks or concerns for consumers.
Specifically, the name of a medicinal product:
- shall not have misleading therapeutic or pharmaceutical connotations;
- shall avoid misleading about the composition of the medicinal product;
- shall not create confusion with the name of another medicinal product.
The NRG is composed of representatives from EU member countries and chaired by a member of EMA.
The main topics of the 7th Revision
The current update of the Guidelines provides additional recommendations on the requirements for acceptability and submission of proposed invention names and also clarifies:
- specific aspects of the criteria applied to address safety and public health concerns;
- international non-proprietary names’ concerns;
- product specific concerns;
- procedures for submitting applications for proposed invention names.
Conclusions
In summary, the latest Revision enriches the list of proposed name selection criteria, including cases drawn from experience gathered in the meantime and summarizing current NRG practice. In addition, this version updates the description of EMA’s process for checking names.
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