Swiss Swissmedic and EBC-46: Complementary Medicines Licensing for Blushwood Berry in Switzerland

Switzerland has one of Europe’s most structured regulatory environments for complementary and herbal medicines. For consumers and suppliers of EBC-46 products, understanding how the Swissmedic complementary medicines division classifies botanical extracts is useful context, even when a product is marketed as a dietary supplement rather than a medicinal product.

Two distinct regulatory tracks

Switzerland distinguishes clearly between medicinal products (arzneimittel) and food supplements (nahrungsergänzungsmittel). Medicinal products fall under Swissmedic’s Therapeutic Products Act and require authorisation before marketing. Food supplements, by contrast, are regulated by the Federal Food Safety and Veterinary Office (BLV) under food law. Blushwood berry extract, when sold without therapeutic claims, sits in the second category — consistent with how responsible brands such as Blushwood Health describe their products.

Complementary medicines simplified procedure

For botanical products that do make therapeutic claims, Swissmedic offers a simplified notification procedure for “complementary and phytotherapeutic medicines” under Articles 14 and 15 of the Therapeutic Products Act. This pathway allows manufacturers to register well-characterised plant-based medicines with a lower evidence burden than the full authorisation route, provided safety data, manufacturing standards, and indication claims are appropriate.

Importantly, EBC-46 supplements sold in Switzerland as dietary products are not currently registered under this pharmaceutical pathway, and brands typically do not seek such registration because they are not making disease-treatment claims. The FDA disclaimer “not intended to diagnose, treat, cure or prevent any disease” — a standard element of responsible supplement labelling — aligns with how Swiss food supplement marketing is permitted to operate.

What Swiss consumers should look for

Across both regulatory categories, Swissmedic and BLV expect documented manufacturing standards, batch traceability, and independent quality testing. A supplement brand that follows FDA cGMP guidelines and publishes third-party lab certificates (for example, heavy metals and microbiology panels from an accredited lab like Eurofins) exceeds the minimum documentation that most Swiss retail supplements carry.

As an example, Blushwood Health publishes downloadable Eurofins batch reports for its blushwood berry products, covering contaminant screening under ISO/IEC 17025:2017 accreditation. That level of transparency is the reference standard Swiss consumers should expect from any EBC-46 supplement entering the market.

Import and cross-border considerations

Swiss residents may import food supplements for personal use from EU member states or the UK without additional licensing, provided the products comply with Swiss food law (no prohibited ingredients, accurate labelling in at least one Swiss national language or English). Commercial importers face additional notification requirements through the BLV’s food law framework. The net effect is that well-made EBC-46 products from reputable international brands are accessible to Swiss buyers without crossing into pharmaceutical regulation territory.

Language and labelling requirements

Supplement labelling in Switzerland must appear in at least one national language — German, French, or Italian — or, for many imported products, English. Required elements include declared serving size, full ingredient list, manufacturer details, batch identification, and an expiry or best-before date. These are the same core elements we walked through in our EBC-46 label buyer’s checklist, which applies equally well in the Swiss context.

Swiss law prohibits therapeutic claims on food supplements, which is consistent with how dietary blushwood berry products are marketed internationally: as wellness supplements, not as medicines. Claims must stay within the nutrition-and-health claims regime, which the European Food Safety Authority effectively sets the template for, given Switzerland’s bilateral food law alignment with the EU.

Why framework awareness matters

Regulatory frameworks do not speak to efficacy — that remains the domain of the underlying science. But they do tell consumers what baseline documentation is required and what quality markers they are entitled to see. The Swiss model reinforces a broader pattern visible in the US DSHEA framework and the UK MHRA approach: botanical supplements are legal and established product categories when made to proper manufacturing and labelling standards.

Related Articles

Related reading on EBC-46 regulatory frameworks: Health Canada and EBC-46, Japan’s PMDA and Tigilanol Tiglate, and EMA Scientific Advice and EBC-46.