Article 30 referral: harmonisation of divergent national authorisations

Article 30 of Directive 2001/83/EC applies where Member States have adopted divergent decisions on the authorisation, suspension or revocation of the same medicinal product. A Member State, the Commission, the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use so that a single assessment produces one harmonised position. The procedure follows Articles 32 to 34 of the Directive and ends with a Commission decision that each Member State must implement by varying its national authorisation.

The typical case is an older originator product authorised separately in many countries over decades, with indications, contraindications and posology that differ from one market to the next. The CMDh keeps a list of products prioritised for harmonisation, and holders can also ask for a referral themselves to clean up their own product information before an expansion or a major lifecycle project. The outcome is a harmonised summary of product characteristics, labelling and leaflet, and sometimes a harmonised quality part of the dossier as well.

What goes wrong: underestimating the clinical work, since the holder must justify every harmonised indication and dose with data, and indications supported in only one country may be lost; failing to prepare the harmonised Module 3 when the CHMP asks for it; and forgetting the downstream effect, because generics of the same product must then bring their own product information into line through variations once the decision is published.

The referral is a substantial project for the holder. It starts with a complete inventory of every national authorisation, its current product information and the data behind each difference, and the submission to the CHMP includes a proposed harmonised text with a clinical overview that defends it. The rapporteur and co-rapporteur assess that proposal, raise questions, and the holder may present an oral explanation before the opinion. Where the quality dossier is also harmonised, the manufacturing and control sections of every national dossier must be reconciled at the same time.

After the decision, the holder files the implementing variations in each Member State within the deadline it sets, and the harmonised texts replace the national ones. From then on the product can be maintained through mutual recognition style procedures rather than separate national ones, which is often the main practical gain.