PV 2 Biologics

• Product Validation
• Section A
• Section B
• Section C
• Section D
• Section E
• Section P
• Section S
• Part III
• Part IV

• Select dosage form and further select “in the form of” from the drop-down list.

• For example, a tablet may be in the form of chewable, coated (enteric, film, or sugar), uncoated, dispersible, effervescent, extended release, sublingual, etc.

• The form that correctly describes it in terms of its product quality control specifications and performance shall be selected.

Note: A separate application for registration is required for each dosage form.

How to Acces Dossage Form in QUEST System ?  

Product Registration >> New Application Form >> Product Validation >> Dosage Form