There is no application form for ATC alterations. Justifications based on use of the system in reimbursement, for pricing or marketing reasons will not be considered.Īny user may in principle propose changes to ATC classifications. If the proposed change is to establish specific ATC groups for one or more substances already classified in another group (usually a various group), it is necessary to submit data that verify that the change is beneficial and represents an improvement of the ATC classification for presenting drug consumption statistics. If new knowledge of pharmacology or mechanism of action is the reason for the proposed change, relevant evidence should be submitted. market research data showing the percentage use for the different indications in a range of countries). If a change in the main therapeutic use is the reason for the proposed change, the data submitted should clearly indicate this change (e.g. It is therefore important to submit data, which justify the proposed change. For this reason, there need to be compelling reasons for changing ATC codes. An important basis for the ATC/DDD system is to maintain a stable system for drug consumption studies. When requesting changes to ATC classifications, the data requirements are similar to the data required for new ATC codes.
#ATC CODE WI091 CODE#
When an ATC code is altered, the DDD is also reviewed. When an ATC code is changed for a substance, the previous code is not reused for new substances.When changing ATC codes for plain products, it should always be considered if it is necessary to change the ATC code for any combination products with the same active ingredient.When new therapeutic or pharmacological ATC groups are assigned, it should always be considered if there are substances in other groups that should be included in the new group.When it is decided to make an alteration, the following principles are used:
Other reasons for changes can be new knowledge about mechanism of action or the need for splitting large and complex groups. Before alterations are made, any potential difficulties for the use of the ATC system in drug utilization monitoring and research are considered and related to the benefits that could be achieved by the alteration.Īlterations in ATC classification can be made when the main use of a drug has clearly changed, and when new groups are required to accommodate new substances or to achieve better specificity in the groupings. An important aim is to keep a stable classification system over time with as few changes as possible and still have a classification where new therapy and new pharmacological principles find an appropriate place.
As the selection of drugs and their uses are continually changing and expanding, regular revisions of the ATC system will always be necessary.Ĭhanges in the ATC classification should be kept to a minimum.
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