Parallel distribution of medicinal products

Parallel distribution is the marketing, in one Member State, of a medicinal product authorised under the centralised procedure and acquired in another Member State by an operator independent of the holder. As the centralised authorisation is valid throughout the Union, the operator does not need a new marketing authorisation. It need only notify its plans to the European Medicines Agency (EMA), which Regulation (EC) No 726/2004 tasks with checking compliance with the terms of the authorisation.

Notification to the European Medicines Agency

The distributor submits its notification before the first placing on the market in the State of destination and informs the marketing authorisation holder and the competent national authority. The Agency checks that the product distributed complies with the centralised authorisation, and in particular that the labelling and package leaflet, drafted in the language of the State of destination, match the authorised and current versions. The notification is subject to a fee and must be updated whenever the authorisation is varied in a way that affects the product information.

The operator’s obligations

Notification does not exempt the distributor from any other obligation. It must hold a wholesale distribution authorisation and, if it repackages or relabels the product, a manufacturing authorisation. Since the safety features provided for by Delegated Regulation (EU) 2016/161 became applicable, it must verify and decommission the original unique identifier, then affix an equivalent identifier when it alters the packaging, in accordance with the rules on falsified medicines. Finally, it must ensure batch traceability so that recalls can be carried out.

Interplay with intellectual property

Notification to the Agency is without prejudice to intellectual property rights. Exhaustion of patent and trade mark rights is assessed under the rules common to parallel import, so that only products placed on the market in the European Economic Area by the holder or with its consent may circulate, subject to the specific mechanism applicable to the new Member States. Repackaging remains subject to the conditions laid down by the Court of Justice of the European Union in trade mark law, foremost among which is prior notice to the holder.

Key points

Parallel distribution concerns only medicinal products authorised through the centralised procedure and rests on prior notification to the Agency, without any new authorisation. The holder should examine each notification received in light of the exhaustion of its rights, the origin of the products and the compliance of the repackaging. For the distributor, updating the product information after each variation of the authorisation is a constant point of vigilance.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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