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The State Agency of Medicines guideline for the naming of medicinal products

26.09.2016
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1. Introduction

The purpose of this guideline is to provide industry with clear guidance on the facts which need to be considered when selecting or constructing a product name. By all means applicants should take into account the principles contained within the Medicinal Products Act, our other national regulations and should conform to the requirements of Directive 2001/83/EC or Directive 2001/82/EC (concerning veterinary medicinal products). The State Agency of Medicines does not comment on issues arising from protection or infringement of trademarks. This guideline does not contain any new legislation or requirements but consolidates all current requirements into a single document, to assist applicants when selecting a product name.
The Applicant/MAH would be expected to review the proposed invented name, applying the criteria outlined in this guideline, before requesting that proposed name of the medicinal product be considered.


2. Legal background

According to Article 1(20) of Directive 2001/83/EC, the name of a medicinal product is:
„The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder“.

It is also understood by legislation that a common name is, according to Article 1(21) of Directive 2001/83/EC, as amended, “The international non-proprietary name (INN) recommended by the World Health Organisation, or, if one does not exist, the usual common name”.

According to Article 1(22) of Directive 2001/82/EC, the name of a veterinary medicinal product is: „The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder“ and according to Article 1(23) of Directive 2001/82/EC, as amended, “common name is the international non-proprietary name (INN) recommended by the World Health Organisation, or, if one does not exist, the usual common name”.

According to Medicinal Products Act § 13 (5):
„The name of a medicinal product and the design of its packaging shall not be misleading with regard to its composition or general effects and shall ensure the distinguishability of the product from other medicinal products. A medicinal product shall be provided with additional precautionary marking at the demand of the State Agency of Medicines.“

In accordance with Regulation No. 28 § 4, section (111) The outer packaging or the package leaflet may include symbols or pictograms designed to clarify the information specified in subsections (8) and (11) and other information compatible with the summary of the product characteristics, to the exclusion of any element of a promotional nature.


3. General principles

3.1 Based on legal regulation in effect a name of the medicinal product can have one of the following structures:

 - Invented name
 - INN accompanied by the name of the marketing authorisation holder
 - INN accompanied by a trade mark

3.2 The name of the medicinal product should not contain pharmaceutical form (and species for veterinary medicinal products).
The name of the medicinal product should be followed by the strength and pharmaceutical form (and species) only where applicable (SPC, PL, labelling).

3.3 The proposed product name should be the same as the name of the existing product if extension application is submitted. According to CMDh guideline "Extension applications in mutual recognition and decentralised procedures member states recommendations": The name of the medicinal product will be the same for the extension as it is for the existing marketing authorisation of the medicinal product.

The same name of the already registered product should be used in case of products with licence for parallel import.

The name of a generic of a centrally authorised reference medicinal product should be the same in all Member States where it is authorised, regardless of the procedure followed for authorisation, i.e. centralised, mutual recognition or decentralised procedure.

Exactly the same name of the medicinal product can be also used in case of the same MAH and same active substance is proposed for medicinal product with different strength or pharmaceutical form


4. Criteria applied when reviewing the acceptability of proposed invented names

4.1 Safety Concerns and Confusion with Another Medicinal Product

The invented name of a medicinal product should not be liable to cause confusion in print, handwriting or speech with the invented name of another medicinal product.

Neither can an invented name be identical with or confusingly similar to the name of a medicinal product that has a different composition and that is currently on the Estonian market or has been in recent years.

The invented name of a medicinal product should not convey misleading therapeutic and/or pharmaceutical connotations.

The invented name should not convey a promotional message with respect to the therapeutic and/or pharmaceutical characteristics and/or the composition of the medicinal product.

4.2 Similarity with International Non-proprietary Names (INN)

  • The closeness either in speech, print or handwriting with its own or a different INN; in accordance with World Health Assembly Resolution (WHA) 46.19 an invented name should not be derived from its own or a different INN.

Decision tree: Invented name similar to INN:

  • Invented names should not contain INN stems in the stem location as published by WHO. This is in accordance with WHA Resolution 46.19 that indicates “The invented names should not be derived from INNs and that INN stems should not be used in invented names, to avoid confusion between different medicinal products and to not frustrate the rational selection of further INNs“.A full list of INN stems is available on the WHO website (reference WHO/EMP/RHT/TSN/2013.1). http://www.who.int/entity/medicines/services/inn/StemBook_2013_Final.pdf?ua=1The Applicant/MAH would be expected to review the proposed invented name to ensure an INN stem is not included in the proposed name.

4.3 Use of abbreviations, qualifiers

  • Promotional qualifications/abbreviations in the name are not acceptable.
  • In considering the acceptability of a qualifier/abbrevation in the name the potential added benefit of the qualifier/abbrevation is taken into account.
  • Proposed qualifiers should not consist of a single letter or number (Arabic and Roman), because they may be confused with the strength and/or posology of the medicinal product. Numbers in general should only be used to indicate the strength of the medicinal product. Exceptions are made e.g concerning the use of an abbreviation HCT for hydrochlorothiazide and stating the number of serotypes present in the vaccines.
  • Qualifiers are allowed on the package and in PL (but not in the SPC) in special cases – e.g if a medicinal product is intended for babies, children or adults or if specific additional data should be added on the package (sugar-free etc).
  • Flavours can be included in Estonian, Latin or in English (e.g. ‘menthol’) in the product name.

4.4 The use of symbols (+, -, =, *, #, „®”, „©”, „™ etc.) is not acceptable. According to Guideline on the readability of the labelling and package leaflet of medicinal products for human use, the capitals in the middle of the name should be avoided (nt ImeRohi).

4.5 An invented name should not include fore-/surnames or any words that have known meaning. Exception to this rule is that the name of a medicinal product can include a registered trademark or the name of the marketing authorization holder.


5. INN accompanied by the name of the marketing authorisation holder

  • The INN used in the name of the medicinal product should be either in the Estonian, Latin or English language.
  • The different strengths of fixed-combination medicinal products should be presented separated by a “/”. The names of the active substances should be presented separated by a “/” and in the same order relating to the strength. Expressing the product strength as “%” is not endorsed.


6. Advisable guidances