Guidelines for ATC classification and DDD assignment - WHOCC
Guidelines for ATC classification and DDD assignment - WHOCC
Guidelines for ATC classification and DDD assignment - WHOCC
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In order to include proposals <strong>for</strong> <strong>ATC</strong> alterations on the agenda <strong>for</strong> the Working<br />
Group meetings, they should be <strong>for</strong>warded to the Centre be<strong>for</strong>e 15 January (March<br />
meeting) <strong>and</strong> be<strong>for</strong>e 15 August (October meeting). These dates should be<br />
considered as a guideline since there might be changes in the meeting dates from<br />
one year to another.<br />
<strong>ATC</strong> alterations decided at the March meeting (e.g. March 2011) will be included<br />
in the <strong>ATC</strong> index the following year (i.e. January 2012). <strong>ATC</strong> alterations decided<br />
at the October meeting of the Working Group (e.g. October 2011) will be included<br />
in the <strong>ATC</strong> index the year after the following year (i.e. January 2013).<br />
2. Data requirements <strong>for</strong> submission<br />
When requesting changes to <strong>ATC</strong> <strong>classification</strong>s, the data requirements are similar<br />
to the data required <strong>for</strong> new <strong>ATC</strong> codes. An important basis <strong>for</strong> the <strong>ATC</strong>/<strong>DDD</strong><br />
system is to maintain a stable database <strong>for</strong> drug consumption studies. For this<br />
reason, there need to be compelling reasons <strong>for</strong> changing <strong>ATC</strong> codes. It is<br />
there<strong>for</strong>e important to submit data, which justify the proposed change.<br />
If a change in the main therapeutic use is the reason <strong>for</strong> the proposed change, the<br />
data submitted should clearly indicate this change (e.g. market research data<br />
showing the percentage use <strong>for</strong> the different indications in a range of countries).<br />
If new knowledge of pharmacology or mechanism of action is the reason <strong>for</strong> the<br />
proposed change, relevant evidence should be submitted.<br />
If the proposed change is to establish specific <strong>ATC</strong> groups <strong>for</strong> one or more<br />
substances already classified in another group (usually a various group), it is<br />
necessary to submit data that verify that the change is beneficial <strong>and</strong> represents an<br />
improvement of the <strong>ATC</strong> <strong>classification</strong> <strong>for</strong> presenting drug consumption statistics.<br />
Justifications based on reimbursement, pricing or marketing reasons will not be<br />
considered.<br />
C. Requests <strong>for</strong> <strong>DDD</strong> <strong>assignment</strong><br />
1. Procedures <strong>and</strong> timing<br />
All new <strong>DDD</strong>s are assigned on request from the users. Requests <strong>for</strong> new <strong>DDD</strong>s<br />
should be addressed to the WHO Collaborating Centre <strong>for</strong> Drug Statistics<br />
Methodology. The application <strong>for</strong>m <strong>for</strong> <strong>assignment</strong> of new <strong>DDD</strong>s is shown in<br />
Annex I <strong>and</strong> copies are available from the Centre (www.whocc.no). Any user may<br />
in principle propose a new <strong>DDD</strong> (e.g. health authorities, pharmaceutical<br />
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