ATCvet Application

ATCvet codes

Requests for classifications of new substances should be addressed to the WHO Collaborating Centre for Drug Statistics Methodology. It is recommended that requests be made using the special application form obtainable from the Centre (see Application form).

A new medicinal substance is normally not included in the ATC system before an application for marketing authorisations is submitted in at least one country. In some cases, it may be necessary to await a classification until the new substance has been approved in at least one country (especially for substances where it is considered difficult to establish a new 5th level). These conditions are set to avoid including in the ATC system too many substances which never become marketed.

Applications for ATCvet codes for new drugs not yet classified are received by the WHO Collaborating Centre for Drug Statistics Methodology continuously in the course of the year. These applications are given ATCvet codes and the classifications are discussed by the ATCvet Working Group at the annual meeting in November/December of each year. When the final decision has been taken, the new codes are included in the ATCvet Index.

Data requirements

The following data should be submitted when requesting an ATCvet code for a substance:

• Chemical structure and relationship to similar drugs
• Pharmacology and mechanism of action, including relationship to similar drugs
• Main indication
• Other indications
• Proposed ATCvet classification, with justification based on the evidence submitted

Herbal and homeopathic remedies are generally not classified in the ATCvet system.

ATCvet alterations

As the range of preparations available is continually expanding, regular revisions of the ATCvet system will always be necessary.

Changes to currently valid codes should be kept to a minimum. A gap in the sequence is preferable to changing existing codes. Before alterations are made, the difficulties they may cause for users of the ATCvet system should be considered and weighed against the possible benefits.

Specific ATCvet codes will be changed if new relevant ATC codes are established. ATCvet codes should be identical to the corresponding ATC codes whenever possible, the only difference being the additional Q at level 1.

• Revisions of human ATC codes are normally incorporated in ATCvet.
• Old ATCvet codes for deleted preparations will not be used for any new substances.
• When a group is changed, consideration should be given to whether certain substances or parts of other groups (e.g. from group QV) could be included in the new group.

The guidelines on ATCvet classification are updated in accordance with changes made to the ATC system.

Procedure for alterations

Any proposals for changes to the ATCvet system should be made and explained in writing, and addressed to the WHO Collaborating Centre for Drug Statistics Methodology.

All proposed changes will be scrutinized by experts and discussed by the ATCvet Working Group before a decision is made.