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Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances
(1997; 41 pages) View the PDF document
Table of Contents
Open this folder and view contents1. General introduction
Open this folder and view contents2. Elements in the INN system
Open this folder and view contents3. Principles for selection of INNs
View the document4. Protection of INNs
Open this folder and view contents5. How to apply for an INN
View the document6. References for supporting material
View the documentAnnex 1: Background information on the INN programme
View the documentAnnex 2: General principles for guidance in devising international nonproprietary names for pharmaceutical substances
View the documentAnnex 3: List of common stems used in the selection of INNs
View the documentAnnex 4: Specific groups of biological compounds
View the documentAnnex 5: WHA46.19 - Nonproprietary names for pharmaceutical substances
View the documentAnnex 6: Procedure for the selection of international nonproprietary names for pharmaceutical substances
View the documentAnnex 7: Applications for INNs through national authorities (addresses)
View the documentAnnex 8: INN request form
 

Annex 5: WHA46.19 - Nonproprietary names for pharmaceutical substances

The Forty-sixth World Health Assembly,

Recalling resolution WHA31.32 on the importance of using nonproprietary names in establishing national drug formularies;

Noting the fundamental contribution of the WHO programme on international nonproprietary names (INN) to effective communication in medicine, and the challenge inherent in maintaining the nomenclature as new substances are introduced into clinical use;

Acknowledging with satisfaction the increasing contribution of generic products to national drug markets in both developed and developing countries;

Noting the current trend to market products with the same active ingredient as, and intended to be clinically interchangeable with, a product currently on the market (multisource products) under trade-marks or brandnames derived from stems or other descriptors for international nonproprietary names nomenclature;

Recognizing that such use, particularly in respect of single-ingredient prescription drugs, may compromise the safety of patients by creating confusion in prescribing and dispensing medicines and by interfering with the orderly development of the nomenclature for international nonproprietary names;

Aware of the concern expressed by the International Conference of Drug Regulatory Authorities at its last meeting about the increasing use of pharmaceutical brandnames that are very similar to or derived from international nonproprietary names;

Noting the recommendation made by the WHO Expert Committee on the Use of Essential Drugs, in its fifth report,1 on the need to discourage, as a matter of urgency, the use of trade-marks that are derived from international nonproprietary names,

1WHO Technical Report Series, No. 825, 1992.

1. REQUESTS Member States:

(1) to enact rules or regulations, as necessary, to ensure that international nonproprietary names (or the equivalent nationally approved generic names) used in the labelling and advertising of pharmaceutical products are always displayed prominently;

(2) to encourage manufacturers to rely on their corporate name and the international nonproprietary names, rather than on trade-marks, to promote and market multisource products introduced after patent expiration;

(3) to develop policy guidelines on the use and protection of international nonproprietary names, and to discourage the use of names derived from INNs, and particularly names including established INN stems as trade-marks;

2. CALLS ON the Director-General to intensify his consultations with governments and representatives of the pharmaceutical industry on ways of reducing to a minimum the problems arising from drug nomenclatures that may create confusion and jeopardize the safety of patients.

Twelfth plenary meeting, 12 May 1993
A46/VR/12

 

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