CRED 8 Presentations

03/07/2024

Fixed combination

Art 10(b) – New fixed combination • ...Product containing active substances used...in authorised products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided ... but not...scientific references relating to each individual active substance

• A combination of active substances within a single pharmaceutical form

• Complete Modules 1, 2 & 3 and 4 & 5 for the combination product • Improvement to the benefit/risk

• Simplification of therapy • Consideration of PK/PD • Justified dosage regimen

The Organisation for Professionals in Regulatory Affairs

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Informed consent

Art 10(c) – Informed Consent Permission for the MA Holder to make use of the pharmaceutical, non clinical and clinical documentation contained in the dossier for the purpose of a subsequent application • Letter of consent essentially confirms permanent access to the data • Both medicines must have the same qualitative and quantitative composition in terms of active substance and the same pharmaceutical form • Cross-reference to Modules 2, 3, 4 & 5 of already authorised medicinal product • Module 1

The product that receives the MA is the same as that cross-referenced other than administratively, so may have different livery and other minor changes

The Organisation for Professionals in Regulatory Affairs

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