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Regulatory & Legal 8 Oct 2026

Carton makers' legal opinion opposes digital-only pharmaceutical package inserts

A legal opinion commissioned by the European Association of Cardboard Box Manufacturers (ECMA) and distributed by the German folding carton association FFI argues against replacing printed pharmaceutical package inserts entirely with electronic product information. The opinion, written by Prof. Martin Wesch, finds that the planned reform of EU pharmaceutical law, on which Parliament and Council reached political agreement in December 2025, does not require full elimination of paper inserts, and recommends a hybrid model. It also warns that print-on-demand in pharmacies lacks the GMP controls, validated processes and documentation of industrial printing.

Why this mattersFull digitalisation of inserts would cut demand for pharmaceutical cartons and leaflets; the opinion gives converters legal grounds to press for a hybrid model.

  • Legal opinion commissioned by the European Association of Cardboard Box Manufacturers (ECMA), issued via the German folding carton association FFI
  • Report written by Prof. Martin Wesch, examining electronic product information under the planned EU pharmaceutical law reform
  • European Parliament and Council reached political agreement on the reform in December 2025
  • The opinion finds EU law does not provide for mandatory full elimination of printed package inserts
  • Where member states allow digital-only supply for certain medicine categories, patients would retain a right to a free printed version
  • It warns pharmacy print-on-demand lacks the GMP standards, validated printing processes and documented controls of industrial production, and recommends a hybrid model
FFI Fachverband Faltschachtel-Industrie
Sources packaging-journal.de
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Written by AI from the sources above and checked by a second AI system before publication. No human wrote or edited this story. How it is made.

Updates

  • 2026-10-09 · Edited before publication: Attribution error: the source states the opinion was commissioned by the European Association of Cardboard Box Manufacturers (ECMA) and merely lists FFI as the distributing source. The story instead named FFI as commissioning body and conflated the two organisations. Corrected, and the patients' right to a free printed version added as a substantive finding.