Guidelines for ATC classification and DDD assignment ... - WHOCC

In order to include proposals for ATC alterations on the agenda for the WorkingGroup meetings, they should be forwarded to the Centre before 15 January (Marchmeeting) and before 15 August (October meeting).ATC alterations decided at the March meeting (e.g. March 2013) will be includedin the ATC index the following year (i.e. January 2014). ATC alterations decidedat the October meeting of the Working Group (e.g. October 2013) will be includedin the ATC index the year after the following year (i.e. January 2015).2. Data requirements for submissionWhen requesting changes to ATC classifications, the data requirements are similarto the data required for new ATC codes. An important basis for the ATC/DDDsystem is to maintain a stable database for drug consumption studies. For thisreason, there need to be compelling reasons for changing ATC codes. It istherefore important to submit data, which justify the proposed change.If a change in the main therapeutic use is the reason for the proposed change, thedata submitted should clearly indicate this change (e.g. market research datashowing the percentage use for the different indications in a range of countries).If new knowledge of pharmacology or mechanism of action is the reason for theproposed change, relevant evidence should be submitted.If the proposed change is to establish specific ATC groups for one or moresubstances already classified in another group (usually a various group), it isnecessary to submit data that verify that the change is beneficial and represents animprovement of the ATC classification for presenting drug consumption statistics.Justifications based on reimbursement, pricing or marketing reasons will not beconsidered.C. Requests for DDD assignment1. Procedures and timingAll new DDDs are assigned on request from the users. Requests for new DDDsshould be addressed to the WHO Collaborating Centre for Drug StatisticsMethodology. The application form for assignment of new DDDs is shown inAnnex I and copies are available from the Centre (www.whocc.no). Any user mayin principle propose a new DDD (e.g. health authorities, manufacturers, researchersand others). However, as with ATC code assignment, it is the manufacturer whowill usually have the best access to the required information for new drugs.42