04 August 2017 - Authored by:Eveline Van Keymeulen
Invented names for centralised medicinal products are reviewed by the Name Review Group (NRG) of the European Medicines Agency (EMA), which meets approximately every two months. The high rejection rate is unfortunately not a new trend, and endures despite the EMA’s revision of its Guideline on the acceptability of names in 2014.
In accordance with the Guideline, applicants for an EU marketing authorisation must ensure that the invented name of a medicinal product:
- Is not liable to cause confusion with any other medicinal product (in print, handwriting or speech)
- Does not convey misleading therapeutic and/or pharmaceutical connotations
- Is not misleading with respect to the composition of the product
- Does not convey a promotional message in respect of the therapeutic and/or pharmaceutical characteristics and/or composition of the product
- Is not offensive and has no inappropriate connotation in any of the official EU languages
The difficulty of finding an appropriate invented name only continues to rise as the number of the products on the market increases. In addition, the challenge is even greater for centralised marketing authorisation applications as a name that seems harmless in one language may reveal inappropriate in another official EU language.
A similar trend can be observed with respect to invented names for medicinal products authorised through the MRP/DCP procedures which are submitted to the national competent authorities. In France, the ANSM rejected more than 269 invented names out of 400 in 2016, and naming discussions often take more than six months. The ANSM submitted draft recommendations on the choice of medicinal product names for public consultation in September 2016 (see our related blog post here). Until the ANSM publishes its revised recommendations, companies may already consult the list of easy-to-confuse names published by the ANSM.
Given these statistics, it is imperative for pharmaceutical companies to carefully consider the regulatory naming requirements as set forth by the relevant Guidelines. In addition to taking into account important trade mark considerations, applicants should plan for the relevant EMA or national regulatory requirements from an early stage.
This post was originally co-authored by Audrey Aboukrat.