Veterinary Biologics Licence

1. What this module does

You give the product, its type and label claim, the status of each application item, and the counts from the efficacy challenge and field safety study.

The tool lists the items the product type needs (backpassage and shedding for live vaccines, master cell stock for cell-line products), calculates the preventable fraction and a one-sided Fisher exact test, checks the controls were validly challenged, and flags open items and field safety gaps.

What you get

• A Word or PDF file: licence application summary with the efficacy summary.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• The Outline of Production.
• Master seed and master cell stock reports.
• The efficacy study report with vaccinate and control counts.
• The field safety study report.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/veterinary-biologics-licence.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the product

   Choose the product type and give the species and the label claim. Tick the cell line box if the product is grown in cells.

   

2. Track the content

   One row per item with its status: complete, in progress, not started or not applicable.

3. Enter the challenge

   Vaccinates and controls challenged and affected, the minimum proportion of controls affected, and the preventable fraction your claim needs.

   

4. Resolve alerts and download

   An invalid challenge, a non-significant difference, or a missing Outline of Production or efficacy study is critical. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Product

2 · Application content

Status: complete, in progress, not started or not applicable. Rows the tool does not recognise are kept as extra items.

3 · Efficacy challenge

Counts of animals affected after challenge (the protocol's primary outcome, for example clinical disease or viraemia).

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• Content by product type.
• Preventable fraction, Fisher exact test and challenge validity.
• Field safety sites and serious adverse events.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Efficacy summary. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US only: USDA APHIS Center for Veterinary Biologics under the Virus-Serum-Toxin Act.

8. Working with other modules

• Release each serial with the Veterinary Serial Release module.

9. Common pitfalls

• Claiming efficacy from a challenge that did not affect enough controls.
• Running field safety at too few sites.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Close the open items

   Mark field safety, prelicensing serials, labels and stability complete, and enter 3 field safety sites.

   Expected resultReady to submit to CVB.