CRED 8 Presentations

03/07/2024

Reference medicinal product

• A reference medicinal product is a medicinal product, which has been granted a marketing authorisation by a Member State or by the Commission on the basis of a complete dossier, i.e. with the submission of quality, pre-clinical and clinical data in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended

• That is - it is not a generic!

The Organisation for Professionals in Regulatory Affairs

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Qualitative and quantitative composition for the active

• Impurity profiles must be similar - normal ICH guidelines on impurities apply (qualified impurities)

• Strength must be the same

• In the case of tablets - dissolution profiles should be similar (in vitro evidence of similarity supporting the in vivo bioequivalence study)

The Organisation for Professionals in Regulatory Affairs

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