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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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