PV 1 Biologics

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

Product Name

Product name is defined as a name given to a product which may either be a proprietary name (an invented name); or a generic name (common name) or scientific name, together with a trade mark or the name of the manufacturer.

• Product name shall consist of dosage form and strength (for single active ingredient product). (e.g. X Brand Paracetamol Tablet 500mg)
• The generic name cannot be used alone as product name but in combination with another name, other than the generic name.