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Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances
(1997; 41 pages) Ver el documento en el formato PDF
Resumen
An International Nonproprietary Name (INN) identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system as it exists today was initiated in 1950 by a World Health Assembly resolution WHA3.11 and began operating in 1953, when the first list of International Nonproprietary Names for pharmaceutical substances was published. The cumulative list of INNs now stands at some 7000 names designated since that time, and this number is growing every year by some 120-150 new INNs. Since its inception, the aim of the INN system has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INNs, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide. As unique names, INNs have to be distinctive in sound and spelling, and should not be liable to confusion with other names in common use. To make INNs universally available they are formally placed by WHO in the public domain, hence their designation as “nonproprietary”. They can be used without any restriction whatsoever to identify pharmaceutical substances. Another important feature of the INN system is that the names of pharmacologically-related substances demonstrate their relationship by using a common “stem”. By the use of common stems the medical practitioner, the pharmacist, or anyone dealing with pharmaceutical products can recognize that the substance belongs to a group of substances having similar pharmacological activity. For example all iodine-containing contrast media are given the prefix io-, while all ß-adrenoreceptor antagonists the suffix -olol. The use of stems is described later in more detail. The extent of INN utilization is expanding with the increase in the number of names. Its wide application and global recognition are also due to close collaboration in the process of INN selection with numerous national drug nomenclature bodies. The increasing coverage of the drug-name area by INNs has led to the situation whereby the majority of pharmaceutical substances used today in medical practice are designated by an INN. The use of INNs is already common in research and clinical documentation, while the importance of the programme is growing further due to expanding use of generic names for pharmaceutical products. The names which are given the status of an INN are selected by the World Health Organization on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. The process of INN selection follows three main steps: • a request/application is made by the manufacturer or inventor, • after a review of the request a proposed INN (prop. INN) is selected and published for comments, • after a time-period for objections has lapsed, the name will obtain the status of a recommended INN (rec. INN) and is published as such. The procedures relating to each of these steps are described in the present document in full detail.
Índice de contenido
Abrir esta carpeta y ver su contenido1. General introduction
Abrir esta carpeta y ver su contenido2. Elements in the INN system
Abrir esta carpeta y ver su contenido3. Principles for selection of INNs
Ver el documento4. Protection of INNs
Abrir esta carpeta y ver su contenido5. How to apply for an INN
Ver el documento6. References for supporting material
Ver el documentoAnnex 1: Background information on the INN programme
Ver el documentoAnnex 2: General principles for guidance in devising international nonproprietary names for pharmaceutical substances
Ver el documentoAnnex 3: List of common stems used in the selection of INNs
Ver el documentoAnnex 4: Specific groups of biological compounds
Ver el documentoAnnex 5: WHA46.19 - Nonproprietary names for pharmaceutical substances
Ver el documentoAnnex 6: Procedure for the selection of international nonproprietary names for pharmaceutical substances
Ver el documentoAnnex 7: Applications for INNs through national authorities (addresses)
Ver el documentoAnnex 8: INN request form
 

Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances


Programme on International Nonproprietary Names (INN)
Division of Drug Management & Policies

World Health Organization
Geneva

WHO/ PHARM S/NOM 1570
Distr.: GENERAL
ENGLISH ONLY

© World Health Organization, 1997

This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however be freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes.

Information on the INN Programme and the INN request form are available on INTERNET:
http://www.who.ch/programmes/dmp/innmain.htm

 

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