Biological Qualifier an INN Proposal

Proposal for Assignment of Biological Qualifiers (BQ) - Final

30 September 2015

| Publication

This voluntary scheme is intended to provide a unique identification code (Biological

Qualifier), distinct from the INN, for all biological substances that are assigned INNs

in accordance with information given in the Bioreview (see page 3). It is intended to

apply prospectively and retrospectively. Adoption of the BQ scheme is a voluntary

decision of the individual regulatory authority. The BQ is used to complement the

INN for a biological substance and it uniquely identifies directly or indirectly the

manufacturer and manufacturing site of the active substance in a biological product.

Availability of the BQ scheme will avoid proliferation of separate and distinct

schemes developed by individual regulatory authorities. The scheme is overseen by

the WHO INN Expert Group and administered and operated by the WHO INN

Secretariat.

WHO Team

INN and Classification of Medical Products (INN)

Editors

International Nonproprietary Name (INN) Programme

Number of pages

Reference numbers

WHO Reference Number: INN Working Document 07.2015