What’s in a name? Updated EMA guideline on naming medicinal products processed through the centralised procedure comes into effect
The updated EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure was adopted by CHMP in December 2023 and came into effect on 1 January 2024. The Guideline was updated following a public consultation which concluded in March 2022.
Key points
The 7th revision of the Guideline builds on rather than overhauls the previous 2014 guidance, and provides more detail on specific scenarios that can arise during the assessment of names for new products by the Naming Review Group (“NRG”). Key points to note include:
- Further detail on the factors the NRG will take into account when assessing risk of confusion with another medicinal product. These factors are set out in a new assessment checklist provided at Appendix 1 of the Guideline.
- Confirmation that where there is a risk of confusion between a proposed invented name and the invented name of a pending Marketing Authorisation Application (“MAA”), the proposed invented name will be conditionally accepted and may be used for the subsequent MAA. However, only the Marketing Authorisation (“MA”) which is granted first will get to keep the invented name. Once the first MA is granted, the other name will be rejected. It is possible for applicants to request a “bilateral negotiation” with the applicant of the conflicting name, in which case the NRG will disclose the identities of the applicants and invented names to the relevant parties. The NRG then withdraws from the process, and it is for the applicants to inform the NRG of the outcome of their negotiations.
- Several requests for applicants to consider “the future life cycle of the medicinal product” when selecting an invented name, and also to inform the NRG where there are changes to key aspects of a product profile which might impact acceptability of an invented name.
- Prohibition on conveying a promotional message in an invented name, e.g. by overstating product efficacy.
- Application of a “50% similarity rule” where the proposed invented name is similar to an INN. This means either (a) 50% or more of the proposed invented name is made up of INN parts; or (b) 50% or more of the INN is included in the proposed invented name.
EMA name review procedure
Additional detail on the EMA procedure for checking proposed invented names is also provided.
A name review request should be submitted once CHMP has confirmed the product is eligible for evaluation under the Centralised Procedure (this can happen 18 to 7 months prior to planned MAA submission date). It is possible to submit the MAA before a proposed invented name has been accepted, but the name must have been selected and approved at least one month before the adoption of the CHMP opinion on the product MA.
Up to two proposed names can be accepted per MAA. The default position is that once two names have been accepted by the NRG, new requests for review of additional names will not be allowed (e.g. the applicant cannot withdraw an approved name and submit a new request simply because it considers it the new name more favourable). However, the NRG may depart from this rule for various reasons, including issues relating to trade mark law.
Applicants are strongly encouraged to research their proposed names before submitting a request, by considering these against existing medicinal products authorised in the EEA under both centralised and national procedures. The EMA’s Art.57 database will be helpful in this regard. However, this database does not include invented names which have already been considered by the NRG but where the MA has not yet been granted.
There is also a plea for applicants to give consideration to potential confusion with names of medical devices and food supplements, although no guidance is provided on how to go about this in practice.
Trade mark considerations
A key issue for applicants is to ensure the EMA procedure above dovetails with their trade mark filing strategy. Filing a trade mark too early before sufficient research has been conducted on a proposed name risks obtaining a mark for a brand which is later rejected by the NRG. However, if you wait until a name has been accepted by the NRG, you could run into difficulties in obtaining the trade mark, as trade mark issues would not necessarily be flushed out in the NRG procedure (where the focus is patient safety rather than brand protection). Careful consideration of a potential brand name from both a regulatory and trade mark perspective is therefore needed at an early stage, and before a company becomes too attached to a potential name.
MHRA naming guideline
Finally, it should be noted that the EMA Guideline discussed above only applies to MAAs via the centralised procedure. For national MA applications to the MHRA (in the UK), the MHRA’s Guideline on naming medicinal products (2019) should be taken into account.
