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Therapeutic Use Exemptions (TUE) Application Form Please complete all sections in capital letters or typing. Athlete to complete sections 1, 5, 6 and 7; physician to complete sections 2, 3 and 4.
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The international testing agency formrapeutic is a regulatory document required for the assessment of therapeutic substances in various countries.
Entities involved in the research, development, and marketing of therapeutic substances, such as pharmaceutical companies and research organizations, are required to file this form.
To fill out the form, gather the necessary data on the therapeutic substance, including its composition, purpose, and testing results, and follow the specific guidelines provided by the regulatory authority.
The purpose of the form is to ensure the safety, efficacy, and quality of therapeutic substances before they are approved for use in different markets.
Required information includes substance identity, manufacturing details, preclinical and clinical trial data, adverse effect history, and proposed labeling.
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