Work

Sustainable pharmaceutical packaging under the European Union regulatory framework

Year: 2026

Type: article

Abstract: Pharmaceutical packaging must protect medicinal product quality and patient safety while responding to increasing pressure to reduce material use, greenhouse-gas emissions, and packaging waste. This structured integrative review examines how the European Union Packaging and Packaging Waste Regulation, life-cycle evidence, material innovation and digital information systems affect pharmaceutical packaging decisions. Peer-reviewed studies, official legislation, standards and regulatory guidance were critically synthesised, while company data were used only when independently verifiable evidence was unavailable and were explicitly labelled as industry evidence. Published life-cycle assessments show that environmental rankings depend strongly on the functional unit, system boundary, dosage format, secondary packaging, energy mix and end-of-life assumptions; therefore, broad claims that a single material consistently delivers fixed carbon reductions are not scientifically transferable. High-density polyethylene, polypropylene, paper-based structures, polylactic acid and cyclic olefin polymers offer specific opportunities, but each presents trade-offs involving barrier variability, pharmaceutical-grade purity, extractables and leachables, sterilisation, forming performance, recycling infrastructure and regulatory requalification. The PPWR introduces important circularity requirements but also includes pharmaceutical-specific derogations, and it does not automatically impose a Digital Product Passport on every medicinal package. Digital product information and traceability may improve accessibility and data availability, although their environmental benefit, interoperability, validation and cybersecurity requirements need further evidence. Sustainable packaging transitions should therefore follow a product-specific benefit-risk approach in which patient protection and product quality remain non-negotiable, and environmental gains are demonstrated through comparable life-cycle and performance data .

Source: Discover Sustainability

DOI: 10.1007/s43621-026-04534-6

Authors: Ivana Mitrevska, Dino Karpicarov, Sonja Burcevska, Elizabeta Karadzinska, Olivera Paneva

Institution: Goce Delcev University

Language: English

Topic: Environmental Impact and Sustainability

Subfield: Environmental Engineering

Field: Environmental Science

Domain: Physical Sciences

SDGs: Responsible consumption and production, Good health and well-being

Open Access status: gold

Estimated APC paid: $1,390