How do pharma, biotech, MedTech and IVD companies manage the PPWR (Regulation (EU) 2025/40) without overreading the Article 6(11) exemption?
We build a PPWR programme by packaging level: scope clarification along the narrow Article 6(11) exemption, recyclability and recycled-content assessment for the levels that are not exempt, and supplier requalification and change control through to harmonized labeling under Article 12. The costliest misjudgment is rarely the regulation itself, but reading the exemption too broadly: extending it to cartons, leaflets or transport packaging where it only applies under one condition means planning past most of the packaging volume that stays in full scope.
Overview
Why does PPWR compliance become a supply-chain programme for pharma and MedTech?
PPWR scope clarified by packaging level · Article 6(11) exemption correctly delimited · Supplier requalification run as a programme
Last updated: August 12, 2026
The PPWR (Regulation (EU) 2025/40) has been in force since 11 February 2025 and enters general application on 12 August 2026, covering all packaging placed on the EU market, pharma, biotech, MedTech and IVD included. The Article 6(11) safety exemption exists, but it is narrow: it covers the immediate, contact-sensitive packaging and the outer packaging only where that outer packaging is necessary to preserve the quality of the medicinal product. PPWR programmes typically stall at these points:
- The Article 6(11) exemption is read as a blanket pass for "everything around a medicine", instead of a narrowly framed, conditional exemption for the immediate packaging and the outer packaging only where preservation requires it.
- Cartons, leaflets, bundled and transport packaging are wrongly treated as exempt, even though they fall within full scope and must meet the core obligations under Art. 6, 7, 10 and 12.
- Recyclability (Art. 6), recycled content (Art. 7) and labeling (Art. 12) carry their own, staggered minimum dates (2030/2035/2038 and 2028 respectively), which get mistaken for a single deadline.
- The packaging supply chain is only planned in after the technical decision: material specification, supplier requalification, sample testing, change control and updating the technical documentation need lead time that a quarterly plan does not capture.
- Labeling, Regulatory Affairs, Quality Management and the CDMO or supplier side do not move in sync, so artwork changes end up without a coordinated change-control path.
Services
How we support you
PPWR Scoping & Exemption Assessment
Mapping the portfolio by packaging level and honestly recording where the Article 6(11) PPWR exemption actually applies and where it does not, prioritized by remaining time to the staggered minimum dates. The deliverable is a scope read with packaging level, exemption status and timeline per product line.
Recyclability & Recycled-Content Assessment
Assessing the non-exempt packaging levels against the design-for-recycling requirements under Art. 6 and the minimum recycled-content share under Art. 7, cross-checked against the technical documentation. The deliverable is an assessed gap list per packaging level with a recyclability-grade estimate and a recycled-content evidence path.
Supplier Requalification & Change Control
Running the packaging supply chain as a programme: specifying material, requalifying packaging suppliers, testing samples, running change control, and adapting artwork and technical documentation to the harmonized labeling under Art. 12, coordinated with the CDMO and marketing-authorization variations. The deliverable is a scheduled requalification and change-control plan across the affected suppliers.
How we work together
What it comes down to
The PPWR turns costly most often on a single misjudgment: the assumption that pharma packaging is exempt. The Article 6(11) safety exemption exists, but it only covers the immediate, contact-sensitive packaging (blister packs, vials, ampoules, prefilled syringes) plus the outer packaging where that is necessary to preserve medicinal-product quality. Cartons, patient leaflets, bundled packs and transport packaging fall within the full scope of the regulation. Reading the exemption more broadly means planning past most of the packaging volume that actually has to meet the four families of obligation under Art. 6, 7, 10 and 12.
The second bottleneck is the deadline logic. Recyclability grades, minimum recycled-content shares and harmonized labeling each carry their own staggered minimum dates (2030, 2035 and 2038 for Art. 6, 2030 and 2040 for Art. 7, 2028 for Art. 12), which can move outward but not inward. The critical path to get there is not the labeling layout, it is the packaging supply chain: specifying material, requalifying suppliers, testing samples, running change control and updating the technical documentation. We run this programme in sync with Regulatory Affairs and Quality Management, so the carton conversion does not stall on a supplier negotiation under time pressure.
Our approach
Our approach
Step
Result
PPWR scoping
Portfolio sorted by packaging level, exemption status under Art. 6(11) documented per level.
Gap assessment
Assessed gaps on recyclability (Art. 6), recycled content (Art. 7), minimization (Art. 10) and labeling (Art. 12) per packaging level.
Supplier requalification
Requalified packaging suppliers with tested samples and a documented change-control path.
Artwork & labeling adaptation
Adapted artworks and technical documentation, aligned with Regulatory Affairs and marketing-authorization variations.
Monitoring & deadline management
Schedule across all minimum dates (2028/2030/2035/2038) with an escalation path if the delegated acts shift.
Common pitfalls
Where projects commonly fail
The Article 6(11) exemption is read too broadly.
It covers the immediate, contact-sensitive packaging and the outer packaging only where necessary to preserve medicinal-product quality (point (d)), not cartons, leaflets or transport packaging as a whole. Extending the exemption to these levels means planning past most of the carton volume that stays in full scope.
The staggered deadlines (2030/2035/2038 for recyclability, 2028 for labeling) are treated as fixed dates instead of minimums.
The regulation ties each date to the entry into force of the corresponding delegated or implementing acts, whichever is latest: the dates can move outward, not inward.
Labeling gets planned in isolation from the supply chain.
An Art. 12 artwork update without coordinated packaging-supplier requalification and change control produces a layout that does not carry the material change with it: both changes run through the same change-control record and belong on the same schedule.
Recycled-content evidence under Art.
7 gets confused with the recyclability deadline under Art. 6. Both obligations carry their own timelines (2030/2035/2038 for Art. 6, 2030/2040 for Art. 7) and their own evidence logic; mixing them up means missing the earlier of the two deadlines.
Supply Chain & Technical Operations
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2025/40 (PPWR): primary text, Art. 6, 6(11), 7, 10, 12 and recitals on the medicinal-product exemption
- Directive 2001/83/EC and Regulation (EU) 2019/6 (definition of primary and outer packaging, referenced by Art. 6(11) PPWR)
- Entourage article "PPWR: Why Pharma Packaging Is Not Exempt" (ppwr-pharma-packaging-nicht-ausgenommen, fact-checked 10 August 2026)
- EUR-Lex: Regulation (EU) 2025/40, Official Journal of the European Union
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Regulation (EU) 2025/40 (PPWR): general application from 12 August 2026
- PPWR Art. 6 (recyclability / design for recycling)
- PPWR Art. 6(11) (exemption for contact-sensitive primary packaging of medicinal products)
- PPWR Art. 7 (minimum recycled content in plastic packaging)
- PPWR Art. 10 (packaging minimization)
- PPWR Art. 12 (harmonized labeling of packaging)
- Directive 2001/83/EC (medicinal products for human use: definition of packaging levels)
- Regulation (EU) 2019/6 (veterinary medicinal products)
Related topics
Sustainable Manufacturing →
Anchor recyclability and recycled-content evidence within material flow analysis and the ESG roadmap.
Manufacturing & Supply Chain Management →
Run packaging-supplier requalification and CDMO coordination as a programme within the supply chain.
Regulatory Affairs →
Synchronize artwork, labeling and change control with marketing-authorization variations.
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