(1997; 41 pages)
5.2 INN request form
Before a suggested name can be evaluated by the INN Secretariat, complete information must be provided on a request form to facilitate uniform handling of the data and to assure that pertinent items have not been omitted. It is important that the information is as comprehensive as possible. If parts of this information are missing or explanations are unclear or incomplete, the INN Secretariat will request the applicant to furnish the missing data. This can result in delay because selection of an INN requires the availability of all relevant information to the INN experts.
The following explanations will help applicants to complete the INN form. If additional information is needed, an applicant may contact the INN Secretariat at the World Health Organization, DMP/QAS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland. (Telephone: +41/22/791 36.36/36.60. Facsimile: +41/22/791.07.46. Internet: email@example.com).
Suggested names in order of preference
An applicant may make 3 suggestions for an INN relating to the acid, base or alcohol of a specific chemical entity under investigation. The suggested name should be a single word and not inconveniently long.
Nonproprietary names are developed by a system that relates compounds with chemical, pharmacological or therapeutic similarity. Therefore, whenever justified, the suggested name must incorporate the established common stem. A list of stems may be found in the document entitled The use of common stems in the selection of international nonproprietary names (INN) for pharmaceutical substances (WHO/PHARM S/NOM 15) which is updated regularly.
Occasionally stems require modification. For example, some drugs inhibit a-adreno-receptors as well as ß-adrenoreceptors and exhibit a specific structural variation from the “-olol” prototype. Accordingly, for this type of drug, the stem was modified by one letter to “-alol”. This change introduces a nuance in the naming of related groups of drugs that may not be apparent to every observer but would be understood by someone familiar with the naming conventions of the ß-adrenoreceptor antagonists and related compounds. The important point is that similar compounds have a common element in the name that imparts useful information.
It is imperative that the newly suggested name does not conflict with existing chemical names, other nonproprietary names or trade-marks. Therefore, the INN Secretariat requests the applicant to verify the absence of conflicts with existing chemical names, common names for insecticides, other nonproprietary names, and trade-marks. Some firms routinely perform exhaustive searches for possible conflicts with a suggested INN and for pharmacologically and chemically related compounds with already assigned INNs; the INN Secretariat would appreciate receiving this information to avoid search duplication.
Chemical name and description
Chemical information should be as complete and as current as possible. Information on stereochemistry should be included if known. The chemical names will be in accordance with the nomenclature rules of the International Union of Pure and Applied Chemistry (IUPAC) as interpreted by the Chemical Abstracts Service (8th collective period); the Chemical Abstracts Index names in their current style may also be included as additional information. The chemical name provided by the manufacturer is reviewed for accuracy and to confirm that its construction follows accepted chemical nomenclature rules.
A description is used to identify a substance that is insufficiently defined to be assigned an IUPAC and CAS chemical name. This description will be superseded by the chemical name when the drug substance is fully characterized.
Precautions are taken to ensure confidentiality of the material submitted to WHO, but an applicant should not attempt to obtain an INN before all patent procedures are completed and until full chemical information can be made available to WHO.
Without a graphic formula, it may be difficult to determine if an INN already exists. In addition, the graphic formula is necessary to relate the new drug to existing compounds in the same chemical family. Guidelines for drawing structures may be found in the document entitled Graphic representation of chemical formulae in the publications of International Nonproprietary Names for pharmaceutical substances (WHO/PHARM/95.579), available from the INN Secretariat upon request.
A one-line molecular formula constructed in accordance with accepted chemical practices should be supplied. The molecular formulas should be given in the following manner, e.g. C21H28N2.
Chemical Abstracts Service (CAS) registry number
If a CAS registry number has been assigned to a new compound before it is submitted to the INN Secretariat, the number should be included on the form. If no number has yet been assigned, the manufacturer should obtain the CAS registry number from Chemical Abstracts Services for publication in the INN lists. Proof of the entry will be required.
Tradenames (known or contemplated)
If a trade-mark has been issued for the drug, it should be entered on the form. List any national or international trade-marks (and manufacturers) and the name of the country where the trade-mark is registered.
Any other name or code
Sometimes, long before a nonproprietary name or a trade-mark has been selected for a new compound, it may acquire a trivial name that has been used in the laboratory and scientific literature. The INN Secretariat would like to be made aware of such names but requests manufacturers not to create, use, or in any way encourage the creation of trivial names for new drugs. The fact that a trivial name has become accepted in the literature will not ensure its adoption as a nonproprietary name and may only cause confusion when an official nonproprietary name is selected. It is therefore recommended to use codes before the publication of a recommended nonproprietary name and indicate these on the request form to the INN Secretariat as an additional reference.
Principal therapeutic use(s) and posology
It is important to know the therapeutic category for the new compound as such information may determine the stem selected for the nonproprietary name. Pertinent reprints presenting evidence of the claimed therapeutic use should be included with the application (for terminology, please see Pharmacological Action and Therapeutic Use of Drugs, a list of terms, English/French/Spanish, 1996 (PHARM/96.320).
The pharmacological action should be explained in as much detail as possible, since it may also influence the stem selected for the compound. Again, pertinent reprints must be included to support the claimed action (for terminology, please see above).
Verso side of request form
Date of clinical trial
As a general guide, the development of a drug should progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection. An approximate date when clinical trials began is requested. The intent of this request is to assure that clinical trials are underway. It is the belief that if a drug has entered clinical trials, there is a reasonable expectation that it will be marketed and thus the name selected will have been developed for that need and purpose.
In case the development is stopped, the manufacturer should inform the INN Secretariat as soon as possible, in order to halt the selection process.
Availability of suggested names
The originator of the INN request confirms with his signature that the suggestion is made on the understanding that, insofar as is known, none of the suggested names are either registered or pending registration.
Permission to publish the CAS registry number
The applicant herewith confirms that the CAS registry number sent to the INN Secretariat is correct and may be used in the INN lists.
This section allows the applicant to give additional comments and/or information.