SPI Intelligence for Pharma and Healthcare Packaging

Who this page is for

Regulatory, packaging and sustainability teams at pharmaceutical, vaccine, consumer health and medical device companies, and the converters, glass, aluminium and plastic suppliers who serve them. Safety and product rules come first in this sector: a material change must protect stability, sterility and dosing, and often needs a regulatory variation. That makes it important to know which packaging rules actually apply before planning any redesign.

Three of the tracker’s rule types weigh most here: EPR, recycled content and labelling. Most EPR rules apply across all products; most exemptions sit in design and tax rules.

Scope first: which rules exclude medicinal and medical packaging

Definitions. Immediate packaging is packaging in direct contact with a medicinal product, as used in Directive 2001/83/EC. Contact-sensitive packaging is a PPWR term for certain plastic packaging of sensitive products such as medical devices and infant food; check the Regulation’s own definition before relying on it. Outer or secondary packaging, such as the carton around a blister, is usually not immediate packaging.

The table sets out, rule by rule, what the official source excludes and what still applies. It is drawn from the SPI rule notes, which read each rule’s scope against its official source.

Several rules point the other way. Viet Nam’s Decree 110/2026/ND-CP names medicines among the goods whose primary and outer commercial packaging carries mandatory recycling rates (PR-VN-001). The UK packaging EPR regulations, the Oregon, Colorado and California programmes, Germany’s VerpackDG and India’s plastic packaging EPR show no medicines carve-out on the official pages SPI consulted (PR-GB-002, PR-US-002, PR-US-003, PR-US-004, PR-DE-001, PR-IN-001). India’s recycled-content rules exempt uses where a central law or body such as CDSCO does not permit recycled plastic, provided the basis is declared in the annual return (PR-IN-002).

EPR fees and registration

Definition. Extended producer responsibility (EPR) makes the brand owner or importer pay for collecting and recycling the packaging it places on a market, usually through a producer responsibility organisation (PRO).

• EU and Germany. The PPWR has applied since 12 August 2026 (PR-EU-001). In Germany the VerpackDG replaced the Verpackungsgesetz on the same date; companies register in LUCID and join a dual system for packaging that reaches private final consumers, and foreign sellers shipping direct to German end users need an authorised representative (PR-DE-001). A Commission proposal would suspend the PPWR authorised-representative duty for EU-established producers until 1 January 2035, but it is not adopted (PR-EU-012).
• UK. SI 2024/1332 requires UK-established producers supplying more than 25 tonnes of packaging with turnover of £1 million or more to register and report; large producers (over 50 tonnes, over £2 million) also pay disposal fees (PR-GB-002). PackUK’s illustrative 2026-27 fees are modulated by recyclability rating, and its operational plan targets the year 2 notice of liability by the end of November 2026 (PR-GB-003).
• United States. Oregon fees have been chargeable since 1 July 2025 (PR-US-002), Colorado dues since January 2026 (PR-US-003), and California producers had until 1 June 2026 to join Circular Action Alliance, register as independent producers or claim the small-producer exemption (PR-US-004). Minnesota, Maryland and Washington have passed their laws’ effective dates, with the drug and device exclusions noted above; their tracker status is being updated in the 13 October check.
• India and Viet Nam. Indian producers, importers and brand owners register on the CPCB EPR portal and file annual returns, the next by 30 June 2027 (PR-IN-001). Vietnamese producers above VND 30 billion annual revenue from covered products register a recycling plan or pay a Fund contribution before 1 April each year (PR-VN-001).

Viet Nam shows how a medicines-inclusive EPR law sets obligations by material rather than by product.

Recyclability and recycled content

EU recyclability. From 1 January 2030, packaging placed on the EU market must be recyclable, graded A, B or C against design-for-recycling criteria, with grade B the minimum from 1 January 2038 (PR-EU-010). Immediate medicinal packaging and contact-sensitive device packaging sit outside this duty according to recital 34, and the PPWR allows innovative packaging additional time (recital 33). Secondary cartons, leaflets and transport packaging do not benefit from the medicinal exclusion.

EU recycled content. Minimum post-consumer recycled content applies to plastic packaging from 2030 and rises in 2040 (PR-EU-004, PR-EU-005). The EUR-Lex summary lists pharmaceutical packaging and medical devices among the exceptions. The Commission timeline lists a delegated act on evaluating derogations by 1 January 2028 and a review of the 2030 targets by 12 February 2032, either of which could change scope.

India. G.S.R. 237(E) sets recycled content for Category I rigid plastic packaging at 30% in 2025-26, rising to 60% from 2028-29; Category II at 10% to 20%; Category III at 5% to 10% (PR-IN-002). Uses where recycled plastic is not permitted by a central body such as CDSCO are exempt if the basis is declared in the annual return.

Plastic taxes and labelling

Plastic taxes. The UK Plastic Packaging Tax charges £228.82 per tonne from 1 April 2026 on finished plastic packaging components with less than 30% recycled plastic, with immediate packaging of licensed human medicines exempt (PR-GB-001). HMRC has announced that from 1 April 2027 pre-consumer plastic will no longer count towards the 30% threshold. Spain charges EUR 0.45 per kg of non-recycled plastic in non-reusable packaging, excluding packaging for medicines, medical devices and special medical foods (PR-ES-001). See plastic packaging taxes in 2026.

Labelling. The PPWR harmonised material-composition label is due by 12 August 2028 at the earliest, depending on a Commission implementing act still in preparation in October 2026 (PR-EU-003). France requires the Triman logo with Info-tri sorting instructions on household packaging (PR-FR-003). California’s SB 343 restricts recyclability claims on products made after 4 October 2026, but enforcement has been blocked by preliminary injunction since 14 July 2026 (PR-US-011). In pharma, pack graphics also carry regulated product information, so sorting-label changes should be planned with regulatory affairs.

What to do now: a scope-first checklist

These steps come from the actions in the SPI rule notes, ordered for a pharma or consumer health portfolio.

1. Split the portfolio by packaging level. Record for each SKU which components are immediate packaging, which are outer packaging and which are transport packaging, because the PPWR, UK and Spanish exclusions depend on it.
2. Map the exclusion to each market. Use the scope matrix above: an exclusion in Spain or Minnesota does not carry over to Oregon, Germany or Viet Nam.
3. Register everywhere EPR applies. Check LUCID in Germany, UK registration against the 25-tonne and £1 million tests, Circular Action Alliance in Oregon, Colorado and California, and the CPCB portal in India.
4. Price the outer packaging. Cartons, leaflets, shrink wraps and shippers carry the fees and taxes the exclusions do not remove. Model them in the SPI EPR & Plastic Tax Calculator.
5. Plan artwork with regulatory affairs. Book the EU harmonised label change into the next labelling variation cycle, and watch the SB 343 court case before changing US recyclability claims.

Key dates for pharma and healthcare packaging

Most pharma deadlines are fee and reporting cycles rather than design dates. The table shows the dates SPI tracks that apply to medicinal and consumer health packs in at least part of their range.

What seven pharma and health companies have committed to

The SPI Buyers Database lists seven pharma and consumer health companies among its 42 brand owners and retailers, which together publish 179 packaging targets. Figures are as each company reports them; SPI does not audit them.

Sanofi moved its blister-free target from 2027 to 2030 and reports that all new medicines and vaccines have followed an eco-design approach since 2025. GSK finalised the scope and method of its 2030 product and packaging goal in 2025 and plans reduction plans for all in-scope products by the end of 2026; it also uses recycled card in packaging and e-leaflets for vaccines. Reckitt reports an 18% cut in virgin plastic packaging (2024) against 50% by 2030.

How SPI builds this page

SPI Regulation Tracker. Each of the 79 rules in 25 jurisdictions has its official source, dates, last-checked date and an SPI note on scope, actions and open points. The 13 October 2026 check re-read 56 tracker records against their official sources and updated 46. The exclusion matrix above comes from those notes. SPI EPR & Plastic Tax Calculator. 216 published rate rows in 14 markets; it applies rates to your tonnages and does not apply sector exemptions. SPI Buyers Database. Company-reported targets with links; no contacts, volumes, suppliers or specifications.

Limitations. The PPWR exclusions rest on recitals and the EUR-Lex summary because the operative articles did not load during SPI’s checks; confirm them with counsel. SPI does not give legal advice, file regulatory submissions or variations, or carry out stability, compatibility or laboratory testing or certification; where you need these, we can point you to a qualified provider. See methodology and corrections.

Where this fits in your decision

• Understand: filter the SPI Regulation Tracker by jurisdiction and type, and read each rule’s scope note.
• Evaluate: estimate EPR fees and plastic tax on your tonnages in the SPI EPR & Plastic Tax Calculator, then remove exempt items yourself.
• Discover: compare health companies’ targets in the SPI Buyers Database.
• Decide and implement: SPI Consulting maps scope and exposure across your markets.

Related pages: Personal and home care for consumer health ranges sold in retail, and the Industries overview.

When you need more than the data

The SPI Trackers are free. Three SPI Consulting services fit pharma and healthcare work:

• Packaging Regulatory Intelligence: a jurisdiction-by-material obligation map showing enacted rules, exclusions and SPI interpretation in separate columns, with exposure scenarios and a deadline calendar.
• Sustainable Packaging Strategy: options for outer packaging, leaflets and shippers, benchmarked against peers’ public commitments.
• Packaging Procurement & Supplier Intelligence: supplier mapping when a material change is planned, using public capability evidence.

Work is scoped as a Briefing, Sprint, Programme or Retainer, with pricing on request. To discuss a scope question, send an enquiry.