12 August 2026 applies to everyone. No industry gets a blanket exemption - not even pharmaceuticals. Any company that cannot present a valid PPWR Declaration of Conformity for its packaging by that date risks being excluded from the market. And this in a sector that is already governed by the German Medicines Act (AMG), the EU Falsified Medicines Directive, GMP requirements, and CSRD reporting.
The good news: pharmaceutical and OTC companies that take a structured approach can build PPWR compliance on top of existing processes and data - if they start now.
This guide explains what the Packaging and Packaging Waste Regulation 2026 (PPWR) concretely means for pharma and OTC packaging, where it intersects with existing regulations, and how you can close your compliance gaps by August 2026.
Why Pharma & OTC face particular challenges
No other segment combines so many regulatory requirements in a single packaging unit as pharma and OTC.
Since 2019, pharmaceutical serialization has been mandatory in the EU for all prescription medicines - every pack must carry a unique 2D data matrix code with serial number, GTIN, batch number, and expiry date. Tamper-evidence features are required by law. Materials must comply with GMP and be migration-neutral. Leaflet requirements prescribe legibility and completeness.
Now PPWR comes on top. From 12 August 2026, every type of packaging placed on the EU market must have a valid PPWR Declaration of Conformity (DoC) - with no transition period.
This means packaging managers, quality managers, and regulatory affairs teams must operate in two regulatory worlds at once. Anyone who approaches this without structure creates double work - and still risks audit gaps.
The regulatory reality: where PPWR meets pharmaceutical law
PPWR is not an isolated environmental regulation. It lands on top of an already dense web of pharmaceutical rules - creating both overlaps and real conflicts.
| Regulation | What it regulates | Applies to Pharmaceuticals/OTC | Overlap with PPWR |
|---|---|---|---|
| PPWR (EU 2025/40) | Packaging: recyclability, DoC, minimization, PFAS, EPR | ✅ Yes (with limited exceptions) | - |
| EU Falsified Medicines Regulation (2011/62/EU) | Serialization, tamper-evidence for Rx medicines | ✅ Prescription requirement, OTC optional | Serial number = PPWR identification |
| Medicinal Products Act (AMG) | Approval, labeling, package insert, batch release | ✅ Fully comprehensive | Labeling requirements overlap |
| CSRD / ESRS E2 | ESG reporting including chemicals & CO₂ | ✅ Above a certain size | LCA data usable for PPWR |
| EU Deforestation Regulation (EUDR) | Deforestation-free supply chains (wood, pulp for cardboard) | ✅ For paper packaging | Supplier data overlap |
What this means in practice:
- Using the serial number as PPWR identifier: PPWR requires a unique identification of each packaging type in the DoC. Pharma companies that already work with serial numbers under the EU Falsified Medicines Directive can often use these directly as identifiers - which saves significant effort.
- AMG labelling ≠ PPWR labelling: Mandatory information on pharmaceutical packs under the AMG (batch number, expiry date, marketing authorisation number) must be treated separately from PPWR labelling obligations. From 2028 onwards, harmonised EU packaging labels on material composition will be added - another artwork update that should be planned now.
- CSRD data are PPWR data: Companies already collecting LCA (Life Cycle Assessment) data for CSRD reporting can reuse them directly for PPWR recyclability assessments. A single source of truth pays off twice here.
PPWR also creates new challenges for the pharmaceutical industry and includes more obligations than national packaging laws such as the German VerpackG. Limited exemptions exist - but they must be product-specific and documented with evidence.
Primary vs. secondary packaging: two very different starting points
Pharma and OTC companies face an important distinction: under PPWR, primary and secondary packaging start from different positions.
Primary packaging: material changes often difficult
Primary packaging such as vials, ampoules, or blisters is in direct contact with the medicine and must meet the strictest GMP requirements. A material that would be better for PPWR recyclability (for example, mono-material instead of PVC-aluminium laminate) cannot simply be used if it jeopardises product safety.
PPWR recognises this conflict. If a material change would endanger the safety or efficacy of the medicinal product, a limited exemption can be claimed - but: this exemption must be explicitly justified in the technical documentation. A blanket reference to "pharma requirements" is not sufficient.
Manufacturers have already developed more recyclable alternatives in recent years - for example, mono-material blister packs made of PP or PET instead of PVC-aluminium laminates. These developments should be proactively evaluated, even if they are not yet market-ready for every application.
Secondary packaging: use the room to manoeuvre
For folding cartons, outer boxes, and transport packaging, there is significantly more flexibility. Recyclable materials such as grass-fibre board or FSC-certified corrugated board are already available for many pharma secondary packaging types - and at the same time meet PPWR recyclability requirements.
Important note on tamper evidence: Security seals, perforated flaps, and tear seals that ensure first-opening protection under the EU Falsified Medicines Directive can impair the recyclability of the carton. Here too, the PPWR documentation must explain why these elements are indispensable for safety reasons.
The PPWR Declaration of Conformity for pharma: deeper documentation required
For pharmaceutical and OTC companies, the PPWR Declaration of Conformity is not just another form - it is a legally binding proof document that must be presented in authority audits, customs checks, and supplier assessments.
According to Annex VIII of PPWR (Regulation (EU) 2025/40), the DoC must contain the following information:
- Unique identifier of the packaging (for example, article number, serial number)
- Manufacturer details and responsibilities
- Reference to the PPWR requirements met (Articles 5-12)
- Evidence of recyclability and material composition
- PFAS status (relevant for all packaging in contact with food or products)
- Supplier declarations according to Article 16 PPWR
- Signature of an authorised signatory
For pharmaceutical companies there is an additional challenge: the technical documentation must integrate PPWR requirements and pharmaceutical authorisation data without contradictions - across both documentation systems.
Supplier data: the underestimated bottleneck
Under Article 16 PPWR, producers must ensure that all information required for the conformity assessment of their packaging is available - with early coordination with the respective suppliers.
For pharma and OTC companies with complex multi-tier supply chains this specifically means: film manufacturers, printers, adhesive suppliers, and board producers must provide all relevant data (material certificates, PFAS declarations, recycled content). Anyone still collecting this data via email and Excel will struggle to be ready by August 2026.
Product safety vs. recyclability: balancing the trade-offs in practice
The central question for pharma and OTC packaging managers: how far can I go towards recyclability without jeopardising product protection or marketing authorisation?
This conflict is real - but solvable if approached systematically.
Typical trade-offs and practical approaches:
| Challenge | PPWR requirement | Pharmaceutical restriction | Practical approach |
|---|---|---|---|
| PVC-aluminium blister | Improve recyclability | Barrier needed for moisture/light sensitivity | Evaluate PP or PET mono blisters; document exemption justification |
| Tamper-evidence seal | No disruptive components on carton | First-opening protection legally required | Use soluble or perforated seal as compromise; document PPWR exemption |
| Leaflet in plastic wrap | Paper-based or without overwrap | Hygiene protection and legibility | Paper overwrap with recyclability check |
| Large multilingual cartons | Packaging minimisation | AMG mandatory information needs space | Design optimisation in close alignment with regulatory affairs |
The strategy: do not try to change everything at once. Treat secondary packaging as quick wins, document exemptions for primary packaging cleanly, and plan transitions for future product generations strategically.
Your PPWR readiness check: where do you stand today?
Assess your current PPWR preparation with our interactive check - developed specifically for pharma and OTC packaging teams:
Six steps to PPWR compliance for pharma & OTC
Record all primary and secondary packaging: blister packs, vials, ampoules, folding cartons, package insert carriers, and outer cartons. Each unit will require its own PPWR conformity declaration from August 2026.
The PPWR contains limited exemptions for pharmaceutical packaging—particularly for primary packaging where a material change would jeopardize product safety. These must be product-specific and documented checks.
For each packaging unit: evaluate material composition, barrier layers, laminate materials, and labels. Especially critical: PVC blisters, aluminum laminated foils and multi-component closures.
Under Article 16 PPWR, manufacturers must obtain all information for the conformity assessment of suppliers. Plan early coordination with packaging suppliers on PFAS status, recycled content, and material certificates.
For each packaging type, create a PPWR-DoC according to Annex VIII: a unique identifier (e.g., existing serial number), manufacturer details, recycling and material evidence, and the signature of the person responsible.
All supporting documents - recycling evaluation, PFAS declaration, supplier declarations, test reports - should be stored in a structured and auditable manner. Recommendation: a digital platform with versioning to withstand both PPWR and AMG audits.
How Packa supports pharma and OTC teams in practice
Turning scattered packaging data into a usable data foundation - that is the core of what Packa delivers for packaging teams. For pharmaceutical and OTC companies under intense documentation pressure, this is often the decisive difference.
What Packa delivers in concrete terms:
AI-powered spec digitization: Packa reads existing packaging specifications from PDFs, ERP exports, and Excel files and converts them into structured, machine-readable data. Under 2.5 minutes per specification - 100% digitised spec data. Instead of months of manual data preparation, pharma teams start with a complete data foundation.
Automated PPWR check: Packa automatically checks every packaging unit against PPWR requirements - recyclability, PFAS status, packaging minimisation - and highlights compliance gaps at article level.
DoC generator: Packa generates audit-proof PPWR Declarations of Conformity directly from your packaging data - including all mandatory elements under Annex VIII. For pharma teams already working with technical documentation systems, integration into existing QMS workflows is possible.
Centralised supplier communication: Packa structures and tracks data requests to packaging suppliers - no more email chaos for PFAS declarations and material certificates.
Sustainability Cockpit: CO₂ footprint, recyclability rate, and EPR fees in a single dashboard - usable for PPWR evidence and CSRD reporting.
Packa was developed from 850+ real packaging projects with 300+ enterprise customers and 350+ manufacturers. The platform understands the complexity of regulated industries - it is not a generic SaaS product that needs to be bent into shape for pharmaceuticals.
Reference customer Lebensbaum Apotheke uses Packa to manage packaging data centrally and to drive PPWR readiness in a structured way.
PPWR software for packaging management
Check your PPWR readinessTakeaways: what pharma and OTC teams must do now
The PPWR deadline is not an abstract date. It is a hard market requirement that will apply in less than three months. For pharma and OTC teams already operating under the AMG, the Falsified Medicines Directive, and GMP, it is now crucial not to treat PPWR compliance as a separate project, but as an extension of existing documentation processes.
The three most important immediate actions:
- Create a complete packaging inventory - capture every primary and secondary pack, do not overlook any item
- Review and document exemptions on a product-specific basis - blanket exemptions do not exist
- Request supplier data now - PFAS declarations and material certificates need lead time
Teams that have completed these three points by the end of May 2026 can realistically finalise their DoCs by August.
You can find more background on PPWR obligations and timelines in our PPWR compliance overview.
More on the PPWR Declaration of Conformity in detail - including templates and concrete examples.
Does PPWR also apply to prescription drug packaging?
Yes - the PPWR generally applies to all packaging placed on the EU market, including pharmaceutical primary and secondary packaging. There are limited exceptions (e.g. when a material change endangers product safety), but these must be demonstrated on a product-specific basis and documented. There is no blanket exemption for the pharmaceutical industry.
What is the difference between primary and secondary packaging in the PPWR context?
Primary packaging (direct product contact: blisters, vials, ampoules) are subject to stricter safety requirements - material changes toward recyclability are harder to implement. Secondary packaging (folding cartons, outer cartons) are generally easier to shift to recyclable materials. For both, however, the PPWR documentation obligation applies from August 2026.
Can I use an existing serial number for the PPWR conformity declaration?
Yes. The PPWR requires a clear identification of the packaging in the DoC. Pharmaceutical companies that already assign serial numbers under the EU Falsified Medicines Directive (FMD) can reuse them directly as the identifier in the PPWR DoC - saving effort and avoiding duplicate data maintenance.
By when must the PPWR conformity declaration be in place?
As of August 12, 2026, the PPWR conformity declaration for every packaging type placed on the EU market will be mandatory - with no transition period. Those who cannot present a valid DoC risk market exclusion and fines.
What happens if my OTC product has Tamper-Evidence elements that reduce recyclability?
This is a typical trade-off for OTC manufacturers. The PPWR accounts for safety requirements as an exception when it is documented that the Tamper-Evident component is indispensable for product protection. This exemption must be explicitly justified in the technical documentation.
How does Packa help with PPWR compliance for pharma/OTC packaging concretely?
Packa digitizes all packaging specifications (blister, folding carton, outer carton) in under 2.5 minutes per spec, automatically checks PPWR compliance, and generates audit-ready conformity declarations. The platform aggregates supplier data, recyclability assessments, and PFAS evidence on a central data base - ready for authorities' audits and internal QA processes.
