An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.

Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug

World Health Organization

The submission of a single application for a variation that affects more than one marketing authorisation from the same marketing authorisation holder. Source: Worksharing: questions

[FDA] WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully