PV 2 New Chemical Entity

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

Please 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.
  1. Tablets
  • - Caplet, Lozenge, Chewable tablet, Dispersible tablet, Effervescence tablet, uncoated tablet, enteric coated tablet, Sugar coated tablet, Film coated tablet, extended release tablet;
  1.        Capsules
  • - Soft capsule, Hard capsule, Enteric coated capsule, Chewable soft capsule, Extended released capsule;

  iii.        Powder/ Granules;

  1.         Liquid
  • - Emulsion, syrup, spray, suspension.
  • 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