PRIA Antimicrobial New Product Registration - Manufacturing Use
PRIA 4 Fee Determination Decision Tree:
Antimicrobial
You selected Antimicrobial Active Ingredient - New Product Registration - Manufacturing Use Product. Please select the appropriate fee category:
| Action Code | Description |
|---|---|
| A530 | New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where applicant owns all required data; or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing use product that requires no data submission nor data matrix. (2) (3) |
| A532 | New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted. (2) (3) |
| A560 | New manufacturing-use product; registered active ingredient; selective data citation. (2) (3) |
| A565 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review. (2) (3) |