Get Medicines Control Authority Of Zimbabwe Form: Evf 07 Biowaiver For Additional Strengths Application

Completing the Medicines Control Authority Of Zimbabwe Form EVF 07 for a biowaiver application can seem complex. This guide aims to provide step-by-step instructions to help users navigate the online form confidently and accurately.

Follow the steps to successfully complete the online biowaiver application form.

1. Click ‘Get Form’ button to obtain the form and access it in your preferred online format.
2. Fill in the administrative data section: Provide the International Nonproprietary Name (INN) of the active ingredient(s), dosage form, strength, application number, as well as the name and address of both the applicant and the manufacturer.
3. Complete the laboratory information: Enter details for the laboratory or Contract Research Organization where the BCS-based biowaiver dissolution studies were conducted.
4. In the test product section, tabulate the composition of the formulation(s) proposed for marketing and those for comparative dissolution studies. Make sure to include details like batch number, size, and ingredients.
5. Describe the pharmacokinetics of the drug: Specify whether it displays linear or non-linear pharmacokinetics, and include any relevant literature references.
6. In the comparator product section, provide details about the comparator product, including its name, manufacturer, and a copy of the product labeling.
7. Summarize the comparative in vitro dissolution studies: Include summaries of all relevant dissolution protocols and results, along with the methods and conditions applied during studies.
8. Review all completed sections of the form to ensure accuracy and completeness. Make sure all necessary supporting documents are attached as specified.
9. Once the form is complete, save your changes, and consider downloading or printing a copy for your records.

Begin your online application now to ensure a smooth submission process.