Does the PPWR also apply to prescription medicines already regulated under FMD/DSCSA?

Yes. The PPWR is a packaging regulation and applies independently of product-specific regulations such as FMD or DSCSA. It supplements these obligations; it does not replace them. Duplicate labelling must be avoided – GS1 coding can in many cases accommodate PPWR attributes if the data carrier is configured accordingly.

Are blister packs made from PVC-PVDC exempt from the recyclability obligation?

There is no blanket exemption. For packaging that cannot be manufactured from recyclable materials for sterilisation or stability reasons, the PPWR provides for a documented assessment obligation. The delegated act on recyclability defines the precise criteria. Have your materials assessed by an accredited testing institute and document the technical necessity.

Can the existing GS1 DataMatrix code be used to fulfil the PPWR labelling obligation?

In many cases, yes. The PPWR requires a machine-readable code linked to PPWR-relevant information. GS1 DataMatrix codes can be extended with Application Identifiers for PPWR data. Clarify this with your GS1 implementation partner and your serialisation software, as space constraints on primary packaging are frequently the limiting factor.

What rules apply to single-use cold packaging in the cold chain (e.g. -80 °C biotech products)?

The PPWR obliges persons placing products on the market to carry out a demonstrable assessment of whether reusable systems can be used. If this is not possible for technical or safety-related reasons (e.g. contamination risk with reusable systems), this assessment must be documented in writing. Single-use remains permissible but must be justified. Your local Chamber of Commerce can advise you on what evidence is accepted by the competent authorities in your region.

Branchenguide · PPWR

PPWR for Pharma & Healthcare: QR Code Requirements, Sterile Packaging and Serialisation from 12 August 2026

For manufacturers and persons placing pharmaceutical products on the market, Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) introduces far-reaching new obligations from 12 August 2026 – in addition to the existing requirements under FMD and DSCSA. Primary packaging such as blister films, sterile packaging and cold-chain containers is particularly affected, with new labelling and recycling requirements applying. Companies that leverage synergies with existing serialisation systems at an early stage will save considerable effort during implementation.

What the PPWR specifically requires from pharma and healthcare companies

The PPWR obliges all companies that place packaging on the EU market for the first time to comply with minimum requirements regarding recyclability, labelling and packaging minimisation. For the pharmaceutical industry, this means: even packaging required for regulatory reasons – such as sterilised primary packaging, blister films or cold-chain containers – is covered by the Regulation, although certain exemptions may apply.

QR code instead of or in addition to the package leaflet?

Article 11 PPWR stipulates that, from the cut-off date, packaging must bear a machine-readable data carrier through which consumers and market participants can retrieve information on recyclability, materials and disposal. For medicinal product packaging that already carries the GS1 DataMatrix code in accordance with FMD (Falsified Medicines Directive) requirements, extending the existing code is a viable option. Work with your GS1 implementation partner to assess whether the existing DataMatrix code can be extended with PPWR-compliant attributes – this avoids duplicate coding on the primary packaging.

Regarding package leaflets: the paper package leaflet is not abolished by the PPWR. The Regulation does, however, supplement the requirements applicable to the packaging itself. If you have already introduced digital document access as part of your FMD adaptations, this infrastructure can be reused for PPWR data access.

Sterile packaging and blister films: recyclability under scrutiny

The PPWR establishes binding thresholds for non-recyclable components in packaging. For sterile packaging (e.g. Tyvek peel pouches, coextruded composite films) and blister packs made from PVC-PVDC composites, this is one of the greatest technical challenges: many of these materials are currently classified as difficult to recycle. Commission a material assessment in accordance with the requirements of the delegated act on recyclability, which is expected to have entered into force in the second quarter of 2025, and examine whether exemptions for packaging subject to sterilisation requirements apply.

Cold-chain packaging: reusable before single-use

For temperature-controlled transport systems (2–8 °C, -20 °C, -80 °C), the PPWR requires an assessment of whether reusable systems are technically and economically feasible. Document this assessment in a verifiable manner, as authorities may call on companies to demonstrate compliance with the assessment obligation. EPS insulated boxes and single-use cooling packs are under particular pressure; market-ready alternatives such as reusable PCM systems are available today.

Serialisation and PPWR: leveraging synergies

Companies that already serialise in compliance with DSCSA or FMD have a data infrastructure that can be partially reused for the PPWR labelling obligation. The Unique Product Identifiers (UPI) under PPWR can be integrated into existing GTIN structures. Consult your serialisation service provider regarding a PPWR extension.

Legal note: The interpretation of the PPWR in individual cases – particularly for packaging materials that are medically necessary – is complex. Your local Chamber of Commerce (IHK) provides free information on sector-specific exemptions and delegated acts.

Häufige Fragen

Does the PPWR also apply to prescription medicines already regulated under FMD/DSCSA?: Yes. The PPWR is a packaging regulation and applies independently of product-specific regulations such as FMD or DSCSA. It supplements these obligations; it does not replace them. Duplicate labelling must be avoided – GS1 coding can in many cases accommodate PPWR attributes if the data carrier is configured accordingly.
Are blister packs made from PVC-PVDC exempt from the recyclability obligation?: There is no blanket exemption. For packaging that cannot be manufactured from recyclable materials for sterilisation or stability reasons, the PPWR provides for a documented assessment obligation. The delegated act on recyclability defines the precise criteria. Have your materials assessed by an accredited testing institute and document the technical necessity.
Can the existing GS1 DataMatrix code be used to fulfil the PPWR labelling obligation?: In many cases, yes. The PPWR requires a machine-readable code linked to PPWR-relevant information. GS1 DataMatrix codes can be extended with Application Identifiers for PPWR data. Clarify this with your GS1 implementation partner and your serialisation software, as space constraints on primary packaging are frequently the limiting factor.
What rules apply to single-use cold packaging in the cold chain (e.g. -80 °C biotech products)?: The PPWR obliges persons placing products on the market to carry out a demonstrable assessment of whether reusable systems can be used. If this is not possible for technical or safety-related reasons (e.g. contamination risk with reusable systems), this assessment must be documented in writing. Single-use remains permissible but must be justified. Your local Chamber of Commerce can advise you on what evidence is accepted by the competent authorities in your region.

PPWR-Kennzeichnung für Ihre Branche umsetzen

Dynamischer QR-Code, branchenspezifische Scan-Zielseiten, 6 Sprachen für internationale Lieferketten.

Kostenlos starten