Parallel distribution: distribution of a centrally authorised product across Member States

Parallel distribution is the centralised-procedure counterpart of parallel import. Because a centrally authorised product has a single authorisation valid across the EU, no new national licence is needed to move it between Member States. Instead, Article 57(1)(o) of Regulation (EC) No 726/2004 gives EMA the task of checking that distributors comply with the conditions laid down in EU law and in the marketing authorisation. The distributor notifies EMA of each product and the Member State of origin and destination, pays a fee, and EMA issues a parallel distribution notice once it has confirmed that the repackaged or relabelled presentation matches the approved product information in the destination language.

The distributor needs a wholesale distribution authorisation and, where it opens the pack or replaces the outer carton, a manufacturing authorisation, because relabelling and repackaging count as manufacturing. It must notify the marketing authorisation holder of its intention to distribute, as Article 76(4) of Directive 2001/83/EC requires, and it must decommission the original unique identifier and apply an equivalent one under the Falsified Medicines Directive. After the initial notice, EMA expects the distributor to keep its presentations in line with later variations, which is handled through notifications of change and periodic updates to EMA.

For the holder, parallel distribution is lawful competition with its own product, and the main interactions are the repackaging notices, trademark questions and the alignment of the parallel-distributed leaflet with the latest approved text. EMA publishes the list of parallel distribution notices, which gives holders a view of which presentations are being moved between markets, and the register is worth checking before a launch or a pack change in any market with a large price differential.

What goes wrong: distributors whose packs still carry the previous leaflet months after a safety variation, notices that cover a presentation the holder has since withdrawn, and holders who are surprised by a parallel-distributed pack in a market where they had planned a controlled launch. Both sides are also caught by the safety features rules, since a failure in decommissioning or in the new unique identifier generates alerts in the national verification system.