Latest Development Regarding Medicinal Product Names – Guideline Regarding The Naming Of Medicinal Products For Human Use Has Been Published

The “Guideline Regarding the Naming of Human Medicinal Products” (“Guideline”) was published with an announcement dated 31 July 2026 on the official website of the Turkish Medicines and Medical Devices Agency (“Agency”).

According to the information provided in the announcement, the Guideline aims to provide guidance on matters to be taken into account when determining names for medicinal products for human use and outlines the procedures and principles governing the process of assessment of names to be carried out by the Agency.

The Guideline establishes the framework of assessing the similarity between two names. It is stated that, in assessing the degree of similarity between two names, factors such as “similar prefixes/suffixes, the same first and/or last letters, and similar length and number of syllables” will be taken into account. The provisions of the Guideline further stipulates that names of medicinal products for which an application for marketing authorisation has been submitted or which have been authorised must be selected in such a way as not to give rise to confusion with the name of another product; however, criteria such as indications, the target patient population and the means of administration which should be taken into account when determining whether name similarity may lead to confusion between products, are not addressed in the Guideline.

The Guideline also outlines the principles for assessing similarities in regard to International Nonproprietary Name (“INNs”). It is specified that no more than 70% of the proposed name should consist of parts of an INN and/or that no more than 70% of an INN should be included in the proposed name. Furthermore, it is stated that names must not be derived from INN roots and that the proposed name must not contain any similarity to an INN and such situations are explained with examples. From this perspective, taking the INN roots into consideration in the assessment is viewed as a positive development.

Furthermore, it has been stipulated that the name of a medicinal product for human use must not contain elements that could serve to promote or influence preference, and it has been stated that a detailed assessment will be carried out with regard to names or expressions which may be considered promotive.

The Guideline states that the Agency Name Suitability and Similarity Analysis System (“TİBAS”) refers to a system which supports the decision-making process, whereby the system generates a similarity score by comparing proposed names with information in the Agency database; it is envisaged that applicants shall submit a maximum of five name proposals and that a preliminary assessment will be carried out via the TİBAS. Accordingly, only names with a TİBAS similarity rating of 79% or less will be submitted to the Scientific Committee for the Evaluation of Proposed Names for Medicinal Products for Human Use for further assessment. The Scientific Committee or Board for the Evaluation of Proposed Names for Medicinal Products for Human Use (“Committee/Board”) will conduct a review within 30 days. Should the proposed name be deemed unsuitable, the applicant will be notified and will be expected to resubmit an application via TİBAS with up to five new name proposals. In the case where proposed name is rejected, applicants are granted a one-off right to file an appeal within 30 days. This appeal will be assessed by the Committee/Board. 

The Guideline not only regulates the process for new applications submitted after the date of entry into force; they also allow for the re-evaluation of existing names in cases where a notification is made regarding situations posing a threat to public health, or where another marketing authorisation holder raises an objection on the grounds of similarity of product names. In this context, if it is concluded that a name does not comply with the provisions of the Guideline and poses a risk to public health, the applicant or marketing authorisation holder will be informed that the name must be changed. The MA applicant/holder is granted the right to file an appeal within 15 days. The Guideline states that decisions resulting from the assessment of applications regarding product name similarity will be communicated to the parties concerned.

Although the Guideline was published on 31 July 2026, the date of entry into force has been set as 01 January 2027. Until this date, the European Medicines Agency’s (EMA) “Guideline on the Acceptability of Names for Human Medicinal Products Processed through the Centralised Procedure” (“EMA Naming Guideline”), which is also cited as a reference in the Guideline, served as a key guiding document. Whilst the EMA Naming Guideline will continue to serve as an important reference regarding the acceptability of names, the Turkish Guideline is significant in that it regulates the procedures and principles of the naming process and the local assessment criteria to be applied during this process. It is considered that these regulations will enhance predictability regarding the stages of assessing applications for names by establishing a framework of procedures and principles.