Guidelines for ATC classification and DDD assignment - WHOCC

Useful sources of these data would be approved product information documents
from major regulatory countries, or proposed product information documents
stating that these are not yet approved. Summaries of submissions to, or
evaluations from, major regulatory agencies relating to the above are useful, as well
as market research data showing the percentage use for the main indications.
B. Requests for changes to ATC classifications
1. Procedures and timing
A change in the ATC classification should be proposed and explained in writing
and addressed to the WHO Collaborating Centre for Drug Statistics Methodology.
Any user may in principle propose changes to ATC classifications. There is no
application form for ATC alterations. All proposals for changes will be discussed
in the WHO International Working Group for Drug Statistics Methodology.
The steps in the evaluation procedure for changes to ATC classifications are as
follows:
- The Centre will confirm receipt of the proposal for a change and give information
about the time schedule for discussion at the Working Group meeting.
- After approval of the minutes of the Working Group meeting, the decision from
the meeting concerning the proposed change is distributed from the Centre to
those requesting the change (the applicant). Independent of whether it has been
decided to change or not to change, a deadline will be allowed for the applicant to
comment or object to this decision.
- If it is decided to make a change, notification of this change is published at our
website www.whocc.no and in the next issue of the WHO Drug Information. A
deadline is then allowed for any interested part to comment or object to the
change.
- If objections, justified on submitted evidence, are received, the ATC alteration
will be discussed again at the following meeting of the Working Group, and a
final decision will then be taken.
- If no objections are received, the altered ATC classification will be implemented
in the next issue of the ATC classification index.
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