Get Form 46 See Rules 122 B, 122 D And 122 Da Permission / Approval For Manufacture Of New Drug

Filling out Form 46 is an essential step for obtaining permission to manufacture a new drug formulation. This guide provides clear, step-by-step instructions to assist you in completing the form accurately and efficiently.

Follow the steps to properly complete the Form 46 online.

1. Click ‘Get Form’ button to access the form and open it in your preferred document editor.
2. In the first section, enter the number of permission and the date of issue as specified by the licensing authority.
3. In the designated area, fill in the name of the manufacturer or organization (M/s) who is applying for the permission.
4. Provide the complete address of the manufacturer or organization in the appropriate section.
5. List the name of the new drug formulation you intend to manufacture in the required field.
6. Specify the dosage form of the drug, such as tablet, injection, or oral solution.
7. Detail the composition of the drug formulation, including active and inactive ingredients.
8. Outline the indications for the new drug, explaining the conditions or symptoms it is intended to treat.
9. Sign and date the form where indicated, including your name and designation.
10. Review all entries for accuracy and completeness before proceeding.
11. Once all sections are filled out, save your changes, and choose to download, print, or share the completed form as necessary.

Start completing your documents online to ensure a smooth application process.