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Guidelines for ATC classification and DDD assignment - WHOCC

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It is left to the national users of the <strong>ATC</strong> system to classify combination products<br />

based on the principles given in these guidelines. The guidelines are prepared in<br />

order to facilitate this work <strong>and</strong> to ensure that different users of the <strong>ATC</strong> system<br />

classify in a consistent way. If the content of these guidelines is not sufficient to<br />

decide a <strong>classification</strong> of a specific combination, or if it is necessary to establish a<br />

new <strong>ATC</strong> entry, such problems should be addressed to the WHO Centre in Oslo.<br />

The Centre also runs regular training courses to assist those working on the system<br />

at a national level.<br />

The WHO International Working Group <strong>for</strong> Drug Statistics Methodology <strong>for</strong>mally<br />

approves all new <strong>ATC</strong> codes. The group has two annual meetings, normally in<br />

March <strong>and</strong> October.<br />

The steps in the approval procedure <strong>for</strong> new <strong>ATC</strong> codes are normally as follows:<br />

- A st<strong>and</strong>ard letter confirming receipt of the request is returned from the Centre to<br />

the applicant.<br />

- If the new code is easy to assign, a preliminary <strong>ATC</strong> code assigned by the Centre<br />

is returned to the applicant within 6-8 weeks, in<strong>for</strong>ming them that the <strong>ATC</strong> code<br />

still has to be <strong>for</strong>mally approved by the Working Group at the next meeting.<br />

- For substances with more than one alternative <strong>classification</strong> <strong>and</strong> <strong>for</strong> substances,<br />

which are difficult to classify into existing <strong>classification</strong>s, the requests are<br />

discussed in the Working Group be<strong>for</strong>e <strong>assignment</strong> of a temporary <strong>ATC</strong> code.<br />

The applicant receives this in<strong>for</strong>mation within 6-8 weeks after receipt of the<br />

request. After approval of the minutes of the Working Group meetings, the<br />

decision concerning the respective <strong>ATC</strong> code is sent from the Centre to the<br />

applicant.<br />

- After approval of the minutes of the Working Group meeting the new <strong>ATC</strong><br />

codes approved at the meeting are published on the website www.whocc.no <strong>and</strong><br />

in the next issue of the publication WHO Drug In<strong>for</strong>mation. A deadline will then<br />

be allowed <strong>for</strong> interested parties to comment or object to the decisions.<br />

- If objections, justified on evidence submitted, are received, the <strong>ATC</strong><br />

<strong>classification</strong> will be discussed again at the following meeting of the Working<br />

Group. If the decision is kept, then the decision is considered final after this<br />

meeting. If a new decision is taken by the Working Group, notification of this<br />

new <strong>ATC</strong> is published at our website www.whocc.no <strong>and</strong> in the next issue of the<br />

publication WHO Drug In<strong>for</strong>mation. A deadline is then allowed <strong>for</strong> any<br />

interested part to comment or object to the decision.<br />

39

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