The World Customs Organisation (WCO) has released the next edition of the Harmonised System (HS 2028) of customs tariff classifications. The new edition contains changes, which will among other directly affect vaccine makers, biopharma distributors, producers of medical and emergencies- response goods as well as businesses involved in trade with food supplements. The update takes effect on 1 January 2028 and is designed to make vaccine and medical-goods trade more visible and faster to clear during health emergencies.
The HS classification is used by over 200 territories to set tariffs, apply rules of origin, and compile trade statistics. As a result, any changes to the HS will have significant implications for businesses operating in the international marketplace. To prepare for the 2028 edition of the HS classification, businesses should familiarise themselves with the upcoming changes and take steps to re-map their product classifications and update their compliance processes accordingly.
The Harmonised System (HS)
The Harmonised System (HS) is a standardised international numerical system used to classify traded products. Administered by the World Customs Organisation (WCO), it provides a common language for categorising over 5,000 product types and is currently used by more than 200 countries worldwide. The HS classification is a base for identification of applicable duties and taxes and customs administration uses it to conduct trade statistics.
Each HS code consists of six digits, organised into three hierarchical levels: Chapters (the first two digits), Headings (the next two digits), and Subheadings (the final two digits). While these first six digits are universal across all participating countries, many nations add further digits for their own tariff and statistical purposes. The European Union, for example, extends codes through its Combined Nomenclature system (8 digits for exports and 10 digits for imports), while Switzerland uses a unified 8-digit coding for both imports and exports.
While the WCO updates the classification system every five years to reflect changes in global trade patterns and emerging product categories, the 7th Review Cycle was exceptionally extended to six years from July 2019 to June 2025 to conclude discussions affected by COVID-19 pandemic and to finalise the amendments in a comprehensive manner.
What is changing in the HS – in plain language?
The HS, maintained by the WCO, is the internationally standardised nomenclature used to classify goods in international commerce, and it undergoes periodic revisions to reflect evolving trade patterns, technological advancements, and policy priorities. The HS 2028 edition comprises 299 sets of amendments, resulting in a nomenclature of 1,229 headings and 5,852 subheadings. Compared with the HS 2022 edition, six new headings and 428 new subheadings have been created, while five headings and 172 subheadings have been deleted, reflecting a balance between accommodating emerging product categories and streamlining outdated classifications. These changes will have implications for customs classification, tariff determination, and trade compliance across all jurisdictions that adopt the HS 2028 framework.
The HS 2028 edition introduces a new way to classify vaccines. Instead of two broad buckets for human and veterinary use under heading (four-digit code) 3002, as of 2028 there will be two dedicated headings: one for human vaccines (3007) and one for other vaccines (3008). Human vaccines will be further split into thirty-eight disease-specific subheading (six-digit codes). This means shipments can be identified by the disease they target – from measles and polio to influenza, RSV, coronaviruses, Ebola, malaria and more – rather than being lumped together. The vaccine list has also forward-looking approach, which foresee specific codes for pipeline products such as new tuberculosis and Group B Streptococcus vaccines so that trade can be tracked the moment those products launch.
The new HS edition also adds explicit subheadings for essential health-emergency goods. During COVID-19, many countries struggled to apply fast-lane measures because key items lacked clear customs codes. Therefore, the HS 2028 edition addresses this issue by creating dedicated codes for ambulances and mobile clinics, protective face masks and shields, plastic body bags, pulse oximeters and multi-parameter patient monitors, tracheal intubation appliances and suction pumps, and medical ventilators and drop counters. Thanks to those changes customs will be able to recognise these consignments instantly and pre-configure expedited treatment when emergencies strike.
Furthermore, a new heading for dietary supplements shall resolve long-standing ambiguity between food preparations and pharmaceutical products. Clear legal notes support more uniform global classification and cleaner trade statistics in a fast-growing category. Finally, the new HS edition restructures the classification of plastic waste and introduces through legal note 3 to Chapter 39 concept of “single-use”, aligning tariff codes with international environmental controls and improving visibility across plastics life cycles.
Why do these changes matter for Swiss businesses?
These changes matter well beyond the two sectors singled out below: because the new HS structure rewrites the classification logic for an entire product category, any company that manufactures, imports, exports, or distributes goods touching that category should confirm where its products now sit, even if its core business is not vaccines or nutraceuticals.
For vaccine manufacturers and distributors, the new HS classification will become disease specific. Every human vaccine SKU shall be mapped to one of the new six-digit subheadings. That granularity will enable governments to design targeted tariff relief and expedited procedures in crises and will give companies sharper, code-based visibility into cross-border vaccine flows for demand planning and market analysis. It should also support donor and multilateral procurement by anchoring tenders and trade measures to standardised codes rather than narrative descriptions.
Companies with nutraceutical or “borderline” portfolios will feel the impact of the new dietary-supplement heading. For such businesses moving products into a dedicated supplements chapter can change tariff lines, affecting how national eight- and ten- digit splits align with rules of origin, and influence regulatory-affairs position that reference HS-based definitions. Companies shall review claims, dosage forms, and formulations against the new legal notes to ensure consistent global classification.
Timing, rollout and national implementation
The HS 2028 package was published in January 2026 and will enter into force on 1 January 2028. Between now and go-live, the WCO will issue correlation tables that map HS 2022 to HS 2028; these will be the authoritative backbone for reclassification. Each country must transpose the six-digit HS into its national tariff and IT systems and decide how to split further at eight or more digits. Not all jurisdictions will move at the same speed or make identical deeper splits, which can temporarily create differences across markets.
Switzerland has already confirmed its national process and timeline, the federal ordinance to implement HS 2028 should be published in summer 2027 for entry into force on 1 January 2028. Businesses shall expect similar national notices in other jurisdictions in 2026–2027, followed by testing and training phases.
What should businesses do now?
Businesses shall update their masterdata in ERP and global trade management systems to accept the new HS backbone, and plan for dual-code handling on long-lead shipments that straddle year-end 2027/2028. Companies shall also consider refreshing binding rulings where necessary and reconnect bills of materials to rules of origin that will be reindexed to the new HS structure. Furthermore, companies shall coordinate early with customs brokers and logistics providers and prepare change control training for affiliates to mitigate inconsistency across markets during transposition.
Additionally, businesses shall be ready to map all human vaccines to the new disease-specific six-digit subheadings and shift veterinary vaccines to the new "other vaccines" headings. Finally, businesses shall review any imported or exported emergency-response goods against the new subheadings and update product master data accordingly. For supplements and other borderline products, reassess classification and ensure labelling, claims, and formulations align with the new heading and legal notes.
How PwC can support you
At PwC Switzerland, our customs and international trade specialists bring together deep legal, technical, and operational knowledge to help you handle the shifting demands of global trade with confidence. We know customs and international trade management can be complex and under pressure as rules change. So we stay close to your business and offer end-to-end support across customs and international trade compliance and strategy.
- Supply chain and operations: We help you map your physical and financial flows so you can quickly see your current tariff exposure and where you can reduce it. We usually work side by side with our customs specialists to assess preferred customs options and connect tax concepts with regulatory, risk, and wider portfolio considerations. We can support you with fit-for-purpose manufacturing network planning that covers all aspects of protecting access to the crucial US market—from sourcing APIs and raw materials to building a localisation strategy that meets the expectations of US health authorities and policymakers.
- Expert guidance on regulatory changes: Our customs and pharma legal regulatory affairs specialists track regulatory developments closely. We help you understand what new legislation means in practice so you stay fully informed about how these changes might affect your operations.
- Tailored compliance solutions: We work with you to review your current customs and regulatory affairs processes and spot any gaps or risks. Our team then helps you put in place the measures you need so your business stays compliant with all relevant rules.
- Unlocking opportunities: We go beyond compliance to help you spot and capture opportunities created by new customs rules. This can include improving your supply chain, cutting costs, or simplifying and speeding up your customs procedures to support future growth.
Contact us
Simeon Probst
Christina Haas Bruni
Nils Beutling