Guidelines for ATC classification and DDD assignment - WHOCC

- If no objections are received, the new ATC code is considered final and included
in the next issue of the ATC classification index. A list of new final ATC codes
is also published semi-annually on the website www.whocc.no and in the WHO
Drug Information.
In order to include requests for new ATC codes on the agenda for the Working
Group meetings, they should normally be forwarded to the Centre before 15
January (March meeting) and before 15 August (October meeting). These dates
should be considered as a guideline since there might be changes in the meeting
dates from one year to another.
ATC codes approved at the March meeting (e.g. March 2011) will be included in
the ATC index the following year (i.e. January 2012).
For ATC codes approved at the October meeting of the Working Group (e.g.
October 2011), the new codes will appear in the ATC index the year after the
following year (i.e. January 2013).
2. Data requirements for submission
The following data should be submitted when requesting an ATC code for a
substance:
- Chemical structure and relationship to similar drugs
- Pharmacology and mechanism of action including receptor binding profiles and
relationships to similar drugs
- Main indication as shown in the product information in major countries where it
is licensed or submitted for licensing
- Other indications which are licensed or for which licensing is proposed in the
future
- Proposed ATC classification with justification based on the evidence submitted
- Status concerning marketing authorisation
- Information about therapeutic use, if available
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