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 for human or veterinary medicinal product. 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
Based on legal regulation in effect a name of the medicinal product can have one of the following structures:
- Invented name (see also points 4 and 5.1)
- INN accompanied by the name of the marketing authorisation holder (see also points 4 and 5.2)
- INN accompanied by a trade mark (see also points 4 and 5.2)
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 in Estonia 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. INN in different languages is considered the same.
Exactly the same name of the medicinal product already authorised can be also used for another medicinal product in case those two products have the same MAH and at least one identical active substance.
4. General criteria applied when reviewing the acceptability of proposed names
- 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).
- The use of symbols (+, -, =, *, #, „®”, „©”, „™ etc.) is not acceptable.
- The name of the medicinal product of a medicinal product should not convey misleading therapeutic and/or pharmaceutical connotations.
- The name of the medicinal product should not convey a promotional message with respect to the therapeutic and/or pharmaceutical characteristics and/or the composition of the medicinal product.
- 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.
*Exceptions are made e.g concerning the use of an abbreviation HCT for hydrochlorothiazide and stating the number of serotypes present in the vaccines (e.g. CANDESARTAN HCT ACTAVIS; EXFORGE HCT).
**On exceptional cases the use of numbers (together with the corresponding units) in the name can be accepted to indicate the strength of the medicinal product. The different strengths of fixed-combination medicinal products should be presented separated by a “/”. Expressing the product strength as “%” is not endorsed.
Use of abbreviations, qualifiers
In general the use of abbreviations and qualifiers in the medicinal product names are not recommended. In case an abbreviation or qualifier is proposed in the name, the Agency will consider the acceptability of the proposal taking into account the potential added benefit of the qualifier/abbrevation. If the potential added benefit of the qualifier/abbrevation is verified, it could be included in the product name in Estonian, Latin or in English (e.g. ‘vaarikas’, ‘suhkruvaba’; ‘infant’, ‘adult’, ‘menthol’, ‘lemon’).
5. Specific criteria applied when reviewing the acceptability of proposed names
5.1 Invented names
Exceptions may be allowed if it considered reasonable taking into account the approved products` names etc. In general the following applies:
- 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.
- An invented name should not have known meaning, including known names and apellations, and it should not be significantly similar to the known word in Estonian or in other language (e.g. Galaxxy). 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.
- In accordance with World Health Assembly Resolution (WHA) 46.19 an invented name should not be derived from its own or a different INN. Hence, the substantial closeness of the medicinal product name either in speech, print or handwriting with its own or a different INN is not endorsed.
- 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.
Decision tree: Invented name similar to INN:
5.2 Common name followed by the name of the marketing authorisation holder or a trademark
- It is recommended to use international non-proprietary name (INN) or modified international non-proprietary name (INNM) in the proposed medicinal product name. If INN or INNM do not exist, the European Pharmacopoeia (Ph. Eur.) active substance name should be used and if the one does not excist either a usual common name should be used.
- The INN/INNM 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.
- The trademark in the name should be registered by MAH and valid. Validity may be checked from TMview: https://www.tmdn.org/tmview/welcome
6. Advisable guidances
- „Guideline on the acceptability of names for human medicinal products processed through the centralised procedure“ (EMA/CHMP/287710/2014 – Rev. 6)
- Recommendations made by the WHO (e.g. resolution WHA46.19):
- CMDh guideline "Extension applications in mutual recognition and decentralised procedures member states recommendations": http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/
Viimati uuendatud: 25.01.2022