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Terminology owner/maintenance organisation

Name, contact details, website

MedDRA Maintenance and Support Services Organization (MedDRA MSSO) - on behalf of ICH

Mr. Patrick Revelle
MSSO Director
7575 Colshire Drive; McLean, VA 22102, USA

+1 877.258.8280

mssohelp@meddra.org

Formal name of the code system

Medical Dictionary for Regulatory Activities

Short name or abbreviation of the code system name

MedDRA
Technical identifier/s of the code system (OIDs, URNs etc)2.16.840.1.113883.6.163

Scope/domain statement for the code system

(Official or from HTA)

MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.  MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).

MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level.

Link to information about the code system - including how to obtain the content

https://www.meddra.org/

Arrangement or agreements with HL7 for use of content


IP Information and Licensing Information

Subscription

HL7 users of this information - which HL7 products use this link (if known)

Individual Case Safety Report (ICSR) HL7 V3 Specification

Process to request content change

Contact MSSO; 

Other useful Information

Updated twice per year

Information current as at (date)

20190430
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