Changes to guidance document Authorisation of human medicinal product with known active pharmaceutical ingredient

19 gennaio 2024 – Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure (or with a formulation of this active pharmaceutical ingredient that is complex and heterogeneous) may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation). However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterisation. Section 1.1.1. of the guidance document (WL) Authorisation of human medicinal products with known active pharmaceutical ingredient has been adapted accordingly and section 5.10 Requirements for medicinal products with a complex, heterogenous structure has been added. The revised WL enters into force on 15 January 2024.

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