Module 18 2021

07/02/2021

Article 10(1)

 GENERIC PRODUCTS  BIOSIMILAR PRODUCTS

● Cross-refers to a REFERENCE PRODUCT with respect to SAFETY and EFFICACY

● Related to the EXCLUSIVITY PERIOD of the reference product…

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The 8 + 2 + 1 rule

 New products – 10 years exclusivity

 A generic application cannot be submitted until 8 years of the exclusivity period have elapsed

 A generic product cannot be SOLD or SUPPLIED until the exclusivity period has expired.

 In some instances an extra year of exclusivity can be granted to the reference product ● For example, if a paediatric indication is added.

The Organisation for Professionals in Regulatory Affairs

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