Tags
Exception
(verification and abridged)
Applicable for marketing authorization of both Human and Veterinary medicinal products for the following products:
• New Products (New Chemical Entity).
• Biological Products (excluding biosimilars, blood products, vaccines and advanced therapy medicinal products “for human”).
Specific Class of Exception
(excluding biosimilars, blood products, vaccines and advanced therapy medicinal products “for human”).
Regulation
Registration According to Verification and Abridged