Restricted Medicine Application Form & Checklist (Fillable PDF)

Regulatory approval for restricted medicines in Australia requires both a detailed application form and a supporting checklist. Our fillable PDF combines the official CTD Module 1.5 – Restricted Information Certification Form with a practical checklist so you can gather all required data in one place.

By using the Formize PDF Filler, you avoid printing, scanning, and re‑typing. All fields are interactive, autosave, and compatible with Adobe Reader or any modern browser.

Why a Fillable PDF Matters for Restricted Medicines

The Therapeutic Goods Administration (TGA) mandates precise documentation for any medicine that contains restricted information. A fillable PDF ensures:

• Accurate data entry with built‑in validation.
• Instant access to the latest checklist items.
• Secure saving of your work before submission.

Key Sections of the Application Form

The form is divided into two main parts:

1. Part A – Reliance Declaration: Confirm whether you are relying on restricted information or have permission from the sponsor.
2. Part B – Eligibility Assessment: Identify which parts of your dossier qualify as restricted information.

Each part includes tables for listing documents, dates, and contact details.

How to Complete the Form Using Formize

Follow the simple steps below to fill out the PDF directly in your browser. No additional software is required.

Common Mistakes to Avoid

• Leaving optional fields blank when they are required for your specific product type.
• Submitting outdated supporting documents.
• Failing to sign the declaration section electronically.

Where to Submit Your Completed Application

After saving the completed PDF, upload it to the TGA’s eSubmission portal under the "Restricted Representation" category. Keep a copy for your records.