Autumn Introductory Course 2017 - Day 4

Data Exclusivity

Data Exclusivity

● Data exclusivity prevents health authorities from accepting applications for generic medicines during the period of exclusivity. ● Data exclusivity periods across EU and for all regulatory procedures is 8 + 2 (+1) years

● Data exclusivity period starts with the first EU marketing authorisation of the RMP. ● Concept of “global marketing authorisation” applies – “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) ● Consequences: – Data exclusivity is in principle only granted ONCE – Clock starts with initial MA

– 8 years “data exclusivity” – 2 years “market exclusivity” – 1 year additional “market exclusivity” – “8 + 2 + 1” = 11 years exclusivity

The Presentation:

• provided an overview of the available legal basis • provided an overview of the data requirements per legal base • explained specific requirements for generics • explained the concept of bioequivalence • explained the implications of data exclusivity and patent for generics


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