Masterstudiengang "Drug Regulatory Affairs"


An overview on the requirements for the acceptability of invented names for human medicinal products in the Centralised Procedure ***

Dr. Johanna Roggemann (Abschlußjahr: 2010)

With the establishment of the European Medicines Agency (EMEA) and its scientific committee, the Committee for Human Medicinal Products (CHMP), the Centralised Procedure has been introduced. The Centralised Procedure leads to the granting of one Marketing Authorisation for certain medicinal products throughout the European Union. Article 6 of Regulation (EC) No 726/2004 states that “each application of a medicinal product (...), otherwise than in exceptional cases relating to the application of the law on trade marks, shall include the use of a single name for the medicinal product.“ Therefore, finding an acceptable invented name is an important task within the Marketing Authorisation Application in the Centralised Procedure. The procedure of finding suitable and acceptable invented names is time consuming and binds human and financial resources. Also, there is a certain demand from pharmaceutical companies of having an invented name accepted well in advance of the granting of the Marketing Authorisation for a human medicinal product as this impacts e.g. on the planning of launch preparations.

In order to comply with the requirement of invented names that are safe with regard to public health the CHMP itself used to review invented names. In 1999 an ad hoc task force (“Tradename Review Ad Hoc Group”) was established that reviewed the proposals for invented names that the applicants had submitted. This was replaced by the invented Name Review Group (NRG) in 2005. The NRG is in charge of the review of invented names and the development of the “Guideline on the acceptability of names for human medicinal products processed through the Centralised Procedure” (IN Guideline). This Guideline describes the criteria the NRG applies in the invented name review as well as the application and evaluation procedure. The IN Guideline gives advice on what to consider when choosing an invented name.

Finding acceptable invented names for medicinal products in the Centralised Procedure is important from a medical point of view as a name can lead to confusion and the false application of medicinal products. Therefore, closeness to existing invented names, international non-proprietary names and common names must be avoided. Furthermore, the use of qualifiers is in principle allowed but restricted to a certain extent. In addition to trade mark law which is in place to obtain legal protection for a registered trade name the check of invented names of medicinal products is supposed to increase safety of patients and minimise public health concerns and potential safety risks, e.g. caused by mix-up of medicinal products. However, the acceptability rates for invented names at the NRG are low (approx. 50-60%) and there are still aspects within the procedure and the criteria that are unclear and require clarification, e.g. specific assessment methods for invented names of medicinal products. Also, the name review procedure at the NRG could be developed further, e.g. by a harmonisation of national rules between EU Member States within the NRG review procedure and the development of a system to report medication errors consistently.

An NRG-EFPIA (European Federation of Pharmaceutical Industries and Associations) Working Group on invented names in the Centralised Procedure has been established which discusses and clarifies the mutual understanding of the invented name review process in order to increase acceptability rates. This is in the interest of both the EMEA and the EFPIA and this exchange is valuable and ongoing.

With the increasing number of medicinal products that are processed through the Centralised Procedure and the increasing number of Member States in the European Union finding acceptable invented names for medicinal products becomes more and more important but also more and more challenging. Therefore, the task of finding acceptable invented names has become and will in future be an integral part of the Marketing Authorisation Application not only from a commercial and legal perspective but also from a regulatory perspective.

Pages: 40, Annexes: 3, pages: 5