Spring Intro 2023

16/02/2023

What Is A Reference Product? Anything that is or has been approved in Europe on the basis of a full stand alone dossier (which doesn’t cross-refer to data in another approved dossier) is a reference product.

Legal Basis

Type of MAA

Reference Product?

Article 8(3)

Full file

Y

Article 10(1) Article 10(3) Article 10(4) Article 10a Article 10b Article 10c

Generic

N N N

Hybrid

Biosimilar

Well established use

Y Y Y

Fixed dose combination

Informed consent

The Organisation for Professionals in Regulatory Affairs

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Reference Products – Approval Needed In All MSs?

Concept of a European Reference Product

Article 10(1), Directive 2001/83/EC: …The first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted . In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. …

• Means you can submit a generic if the reference product hasn’t been approved in one or more of your target markets.

The Organisation for Professionals in Regulatory Affairs

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