World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme

World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme

World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme was established with a vision to have the INN used by all stakeholders across the world as a common nomenclature for all pharmaceutical substances.

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 existence of an international nomenclature for pharmaceutical substances, in the form of INNs, is important for the clear identification, sale prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.

To make INNs universally available, they are formally placed by WHO in the public domain.

Nonproprietary names are intended for use in pharmacopoeias, labeling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names,e.g. for generics. Their use is normally required by national or, as in the case of the European Community, by international legislation. As a result of ongoing collaboration, national names such as

British Approved Names (BAN), Dénominations Communes Françaises (DCF), Japanese Adopted

Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INNs.

The selection of a new INN relies on a strict procedure. Upon receipt of an INN request form, the WHO Secretariat examines the suggested names for conformity with the general rules, for similarities with published INNs and potential conflicts with existing names, including published INNs and trademarks. A note summarizing the result of these checks is added and the request is subsequently forwarded to the INN experts for comments. Once all experts agree upon one name, the applicant is informed of the selected name.

Newly selected, proposed INNs are then published in WHO Drug Information, which indicates a deadline

for a 4-month objection period. This period is allowed for comments and/or objections to the published

names to be raised. The reasons for any objection must be stated clearly and these will be evaluated by the

experts for further action. Users are invited to refrain from using the proposed name until it becomes a recommended INN, in order to avoid confusion should the name be modified.

The final stage of the selection process is the recommended INN. Once a name has been published as a

recommended INN it will not normally be modified further and is ready for use in labeling, publications,

on drug information. It will serve to identify the active pharmaceutical substance during its lifetime

worldwide. Since the name is available in the public domain it may be used freely. However, it should not be registered as a trademark since this would prevent its use by other parties.

The INN Experts meet twice a year, usually in April and October.

The name cannot be used as an INN until the INN Secretariat completes the publication process. Normally, names are published as a pINN about 6-12 months after the meeting. There is then a 4-month public comment period. If no objections are received, the name is published as a rINN.

All names selected as proposed and recommended INNs are published in a Cumulative list, which is updated periodically. The generic names are presented in alphabetical order by Latin name. Each entry includes:

v equivalent nonproprietary names: : in Latin, English, French, Spanish, Arabic, Chinese and Russian, as well as reference to other common names;

v a reference to the INN list in which the name was originally proposed or recommended, or last amended;

v reference to names of substances that have been abandoned or never been marketed;

v  reference to national nonproprietary names;

v  reference to pharmacopeial monographs or similar official references;

v  reference to names issued by the International Organization for Standardization (ISO);

v  reference to the Convention of Psychotropic Substances, if applicable;

v  reference to the List of Narcotic Drugs under International Control, if applicable;

v  the molecular formula; its Chemical Abstracts Service (CAS) number.