ECJ rules that generics cannot rely on a pre-EU accession marketing authorisation


The European Court of Justice has ruled on an important aspect of EU marketing authorisation procedures for generic medicines.

An application for marketing authorisation cannot rely on the marketing authorisation of an earlier drug with the same active ingredient if that earlier marketing authorisation does not meet EU standards, even if the original marketing authorisation was granted before EU procedures applied in that member state.

Whilst the Court's conclusion is not altogether surprising, the decision has significant implications for research and for generics firms:

 Products cannot be valid reference products until the original pre-EU marketing authorisation has been fully updated to comply with the EU rules (especially the data in the underlying dossier).

 Drugs companies that compile their own full and free-standing dossiers to support product approvals will be able to generate a new period of data exclusivity, even if a product not authorised under EU law had previously been on the EU market.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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