Spring Intro 2023

16/02/2023

Innovator Lifecycle Management And Data Protection

• Any extensions (e.g. new dosage form) do not get independent new exclusivity • Means that the reference product only benefits from exclusivity once (lifecycle management activities don’t result in new regulatory data protection) • Data protection derived from a “Global Marketing Authorisation” which encompasses all extensions Article 6(1), Directive 2001/83/EC: When a MP has been granted an initial MA … any additional strengths, pharmaceuticals forms, administration routes, presentation, as well as any variations or extensions shall also be included in the initial MA. All these MA’s shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1)

The Organisation for Professionals in Regulatory Affairs

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Other Data Exclusivity Afforded To Reference Products

• Creates an incentive to continue to innovate and meet unmet needs after expiry of conventional protection. • Not commonly seen but for completeness…

Scenario

Exclusivity

New indication for a well-established substance

1 year data exclusivity for new indication

Change of Classification (OTC switch) 1 year data exclusivity for studies related to the change of classification only Paediatric Use marketing Authorisation (PUMA) 8 years data exclusivity 2 years market exclusivity

The Organisation for Professionals in Regulatory Affairs

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