European Reference Product - questions and answers

European Reference Product (ERP)

What is the difference between the two types of reference medicinal product?

Reference medicinal product: Is a medicinal product which is or has been authorised in Denmark in accordance with Danish provisions and where the marketing authorisation application of a generic product refers to the data of such product.

European Reference Product (ERP): Is a medicinal product that is or has been authorised in another EU/EEA member state and where the marketing authorisation application of a generic product refers to the data of such product.

When can you use a European reference product? 

In Denmark, we accept the use of a European reference product for applications submitted according to article 10.1 or article 10.3 of Directive 2001/83/EC as amended, also in situations where a suitable reference medicinal product is or has been authorised in Denmark.

It is thus the choice of the applicant whether to use a reference medicinal product authorised in Denmark or a European reference product, provided that any other requirements for the application type is fulfilled.

Which data protection period will be relevant when you use a European reference product?

If you use a European reference product, then the period of data protection must have expired in the member state where the medicinal product is or has been authorised.

Which SmPC will be used when a medicinal product is to be authorised based on a European reference product?

This will depend on the individual case, but it is possible that the SmPC applicable in the other EU/EEA member state will be authorised.