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Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances

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View the documentPROCEDURE FOR THE SELECTION OF RECOMMENDED INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES*
View the documentPROCEDURE A SUIVRE EN VUE DU CHOIX DE DENOMINATIONS COMMUNES INTERNATIONALES RECOMMANDEES POUR LES SUBSTANCES PHARMACEUTIQUES*
View the documentPROCEDIMIENTO DE SELECCION DE DENOMINACIONES COMUNES INTERNACIONALES RECOMENDADAS PARA LAS SUSTANCIAS FARMACEUTICAS*
 

PROCEDURE FOR THE SELECTION OF RECOMMENDED INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES*

The following procedure shall be followed by the World Health Organization in the selection of recommended international nonproprietary names for pharmaceutical substances, in accordance with the World Health Assembly resolution WHA3.11:

1. Proposals for recommended international nonproprietary names shall be submitted to the World Health Organization on the form provided therefore.

2. Such proposals shall be submitted by the Director-General of the World Health Organization to the members of the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations designated for this purpose, for consideration in accordance with the *General principles for guidance in devising International Nonproprietary Names*, appended to this procedure. The name used by the person discovering or first developing and marketing a pharmaceutical substance shall be accepted, unless there are compelling reasons to the contrary.

3. Subsequent to the examination provided for in article 2, the Director-General of the World Health Organization shall give notice that a proposed international nonproprietary name is being considered.

A. Such notice shall be given by publication in the Chronicle of the World Health Organization1 and by letter to Member States and to national pharmacopoeia commissions or other bodies designated by Member States.

(i) Notice may also be sent to specific persons known to be concerned with a name under consideration.

B. Such notice shall:

(i) set forth the name under consideration;

(ii) identify the person who submitted a proposal for naming the substance, if so requested by such person;

(iii) identify the substance for which a name is being considered;

(iv) set forth the time within which comments and objections will be received and the person and place to whom they should be directed;

(v) state the authority under which the World Health Organization is acting and refer to these rules of procedure.

C. In forwarding the notice, the Director-General of the World Health Organization shall request that Member States take such steps as are necessary to prevent the acquisition of proprietary rights in the proposed name during the period it is under consideration by the World Health Organization.

4. Comments on the proposed name may be forwarded by any person to the World Health Organization within four months of the date of publication, under article 3, of the name in the Chronicle of the World Health Organization.1

5. A formal objection to a proposed name may be filed by any interested person within four months of the date of publication, under article 3, of the name in the Chronicle of the World Health Organization.1

A. Such objection shall:

(i) identify the person objecting;

(ii) state his interest in the name;

(iii) set forth the reasons for his objection to the name proposed.

6. Where there is a formal objection under article 5, the World Health Organization may either reconsider the proposed name or use its good offices to attempt to obtain withdrawal of the objection. Without prejudice to the consideration by the World Health Organization of a substitute name or names, a name shall not be selected by the World Health Organization as a recommended international nonproprietary name while there exists a formal objection thereto filed under article 5 which has not been withdrawn.

7. Where no objection has been filed under article 5, or all objections previously filed have been withdrawn, the Director-General of the World Health Organization shall give notice in accordance with subsection A of article 3 that the name has been selected by the World Health Organization as a recommended international nonproprietary name.

8. In forwarding a recommended international nonproprietary name to Member States under article 7, the Director-General of the World Health Organization shall:

A. request that it be recognized as the nonproprietary name for the substance; and

B. request that Member States take such steps as are necessary to prevent the acquisition of proprietary rights in the name, including prohibiting registration of the name as a trade-mark or trade-name.

1 The title of this publication was changed to WHO Chronicle in January 1959. From 1987 onwards lists of INNs are published in WHO Drug Information.

 

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