![]() It is left to the national users of the ATC system to classify combination products based on the principles given in these guidelines. These conditions are set to avoid including in the ATC system too many chemical entities which never become marketed. In some cases, it may be necessary to await a classification until the new medicinal product has been approved in at least one country (especially for substances where it is considered difficult to establish a new 5th level). The manufacturer will usually wish to know about and be involved in an application for an ATC classification and/or DDD assignment for one of their products, particularly if it is a new drug.Ī new chemical entity is normally not included in the ATC system before an application for marketing authorisations is ready for submission in at least one country. It will usually be the manufacturer who has best access to the information required for an application. health authorities, pharmaceutical manufacturers, researchers and other users). If a substance marketed in a country is not included in the latest version of the annually updated ATC classification index, a request for an ATC code may in principle be sent from any user of the system (e.g. Requests and documentation should accordingly be submitted in English. The official language of the Centre is English. Requests for ATC classification of a medicinal substance should be addressed to the WHO Collaborating Centre for Drug Statistics Methodology in Oslo, Norway ( Application form). Summaries of submissions to, or evaluations from, major regulatory agencies relating to the above are useful, as well as market research data showing the percentage use for the main indications.Īll new entries in the ATC classification system are assigned on request from the users. Useful sources of these data would be approved product information documents from regulatory authorities or proposed product information documents stating that these are not yet approved. Information about therapeutic use, if available. ![]() Status concerning marketing authorisation.Proposed ATC classification with justification based on the evidence submitted.Other indications which are licensed or for which licensing is proposed in the future.Main indication as shown in the product information in major countries where it is licensed or submitted for licensing.Pharmacology and mechanism of action and relationships to similar drugs.Chemical structure and relationship to similar drugs.National issues of the ATC classification may include additional codes not present in this list, which follows the WHO version.The following data should be submitted when requesting an ATC code for a substance: Ĭodes for veterinary use ( ATCvet codes) can be created by placing the letter Q in front of the human ATC code: for example, QC02. Subgroup C02 is part of the anatomical group C Cardiovascular system. ATC code C02 Antihypertensives is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products.
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