Get Btif Template

Filling out the Btif template accurately is essential for the assessment of bioequivalence trial information. This guide will provide you with clear, step-by-step instructions on how to complete each section of the template online, ensuring you have the necessary information and guidelines at your fingertips.

Follow the steps to successfully complete the Btif template.

1. Click the ‘Get Form’ button to obtain the Btif template and open it in your browser.
2. Begin by entering the reference of the session and the date at the top of the form to establish context for your submission.
3. Fill out the type of product and type of dossier. Select the relevant entry and clearly state the type of submission you are making.
4. Input the names and signatures of the first and second assessors. Ensure to provide accurate names and relevant credentials.
5. Complete the section for quality assessor, if applicable, by including their name and signature.
6. Record the reference number and submission date, along with the number of binders included in your submission.
7. Address the proprietary product name, if relevant, and confirm whether the required documents (SPC, PIL) have been submitted.
8. Provide the International Non-proprietary Name (INN) of the Active Pharmaceutical Ingredient (API), along with the strength and pharmaceutical form.
9. Summarize the assessment conclusion by selecting one option: ACCEPTED, ADDITIONAL DATA REQUESTED, or REJECTED.
10. Enter the name and complete address of the supplier, along with the name and address of the Contract Research Organisations where clinical studies were conducted.
11. Continue filling out detailed components as you progress through each section related to bioavailability studies, formulation compositions, clinical study reports, and other necessary assessments. Be diligent in responding to each prompt fully, using clear and concise language.
12. Once all fields are completed, review your entries for accuracy. You can then save your changes, download, print, or share the form as needed.

Complete the Btif template online today to support your submission process efficiently.