Which Czech Authority Regulates Your Health and Personal Care Product in 2026?
If you manufacture, import, or sell health and personal care products, you need to be certain which authority supervises them. The boundary between the competences of SÚKL, SZPI, KHS, and ČOI is often unclear, and an incorrect classification may result in substantial fines or the product being withdrawn from the market. This article explains how to determine the correct regulatory regime for a product under the legislation in force in 2026.
Article contents
Summary of key points
Correct product classification determines the competent supervisory authority and the applicable legal requirements. Misclassification leads to illegal sales and fines in the millions of Czech crowns.
SÚKL regulates medicinal products and medical devices, while SZPI inspects food supplements and KHS oversees cosmetics. ČOI deals with general safety and misleading consumers, while SZÚ only prepares expert opinions.
The decisive criterion is not only the composition, but also the so-called product presentation. If you claim therapeutic effects for a food product or cosmetics, from a legal perspective it becomes a “medicinal product by presentation” and falls under SÚKL’s strict regime in the Czech Republic.
The attorneys from ARROWS, a Prague-based law firm, will help you determine the correct classification, prepare documentation, and represent you during inspections.
How medicinal products, medical devices and ordinary products are distinguished
The basic question is whether your product is a medicinal product, a medical device, cosmetics, or food.
The law does not work with assumptions, but with precise definitions based on intended purpose and presentation.
A medicinal product, i.e., a human medicinal product, is a substance that is presented as having therapeutic or preventive properties. This also includes substances that are capable of restoring or modifying physiological functions through a pharmacological, immunological, or metabolic effect.
Key words such as “treats”, “heals”, “relieves pain”, or “prevents infection inside the body” indicate that products are subject to registration with SÚKL.
A medical device (MD) is an instrument, material, or software intended by the manufacturer for specific therapeutic or diagnostic purposes. The principal intended action of these devices is not achieved by pharmacological means, which is a fundamental difference compared to medicinal products.
Examples include plasters, orthoses, and diagnostic tests, which require conformity assessment, CE certification, and registration in the EUDAMED database.
A cosmetic product is a substance intended to come into contact with the external parts of the human body, teeth, or the mucous membranes of the oral cavity. Its purpose must be exclusively or mainly cleaning, perfuming, changing appearance, protecting, or keeping in good condition.
A cosmetic product must not treat disease, and it is supervised by public health authorities in the Czech Republic.
A food supplement is, from a legal perspective, a food intended to supplement the normal diet and is a concentrated source of nutrients. It must not claim therapeutic effects, and only health claims approved by the European Union are permitted.
Related questions
1. My vitamin “boosts immunity” – does it fall under SÚKL?
It depends on the wording and dosage. If you use an approved health claim, it is a food supplement falling under SZPI. However, if you state that it treats influenza or use therapeutic doses, the product falls within the definition of a medicinal product and, without registration with SÚKL, its sale is illegal. The attorneys from ARROWS, a Prague-based law firm, will audit your claims to ensure they comply with the regulation.
2. I use an antibacterial substance in my product – is it automatically a medical device?
No; it may be a biocide, cosmetics, or a medicinal product depending on the primary purpose. For medical devices, if they contain a substance that could in itself be considered a medicinal product, they are subject to the strictest risk class under the MDR Regulation.
3. I have a CE certificate – does that mean it is a medical device?
Yes, if it is CE within the meaning of medical device legislation, because the CE mark declares conformity with European regulations. Medicinal products registered by SÚKL do not bear the CE mark, but note that toys or electronics also carry the CE mark, which does not mean they are medical devices.
Practical signals to watch for
In practice, it is common to unintentionally step into medicinal product regulation, so it is necessary to monitor warning signals.
If a product claims that it treats or prevents disease, the authorities will assess it as a medicinal product by presentation. Without registration with SÚKL, you expose yourself to the risk of a fine in such a case.
If the product contains a pharmacologically active substance at a dose that changes physiological functions, it is a medicinal product by function. Cosmetics and food must not have a significant pharmacological effect, such as high doses of vitamins.
If your package leaflet includes contraindications and dosing for ill persons, you indicate that the product has strong systemic effects.
Another signal is if a product from a foreign supplier is labelled “Medical Device” or “Pharmaceutical”. Status abroad does not automatically transfer to the Czech Republic, but it is a strong indicator that the importer bears full responsibility for compliance with European standards.
Which regulator you fall under
Each type of product falls under a different supervisory authority with different powers and sanctions.
SÚKL is the key authority for medicinal products and medical devices that require complex registration or conformity assessment. Without registration, sale is illegal, and the approval process may take months to years.
Placing an unregistered medicinal product on the market may result in a fine of up to CZK 20,000,000.
If your product is a food supplement, you fall under SZPI inspections, which monitor safety, quality, and labelling. You must meet limits for contaminants and notify placing on the market to the Ministry of Agriculture.
For misleading labelling or unauthorised health claims, SZPI may impose a fine of up to CZK 50,000,000.
Cosmetic products are inspected by Regional Public Health Authorities (Krajské hygienické stanice) under the methodological guidance of the Ministry of Health. You are required to have a Safety Report for each product and to complete notification in the CPNP portal.
Placing dangerous cosmetics on the market or missing documentation may result in high sanctions under the Public Health Protection Act.
The Czech Trade Inspection Authority (Česká obchodní inspekce) comes into play for ordinary products and monitors unfair commercial practices. It focuses on whether you mislead consumers and whether the product has instructions in Czech.
Fines commonly reach up to CZK 5,000,000, and in serious cases even more.
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Potential issues |
How ARROWS helps (office@arws.cz) |
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Incorrect classification: You sell a cream for “treating eczema” as a cosmetic product. SÚKL initiates proceedings for the sale of an unregistered medicinal product. |
We will carry out a legal classification of the product (so-called borderline analysis). We will determine whether it falls under cosmetics, a medical device, or a medicinal product, and adjust your strategy to ensure it is lawful. |
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Insufficient documentation: You place a medical device on the market without complete technical documentation under the MDR or without a clinical evaluation. |
We will arrange a review of contracts with manufacturers. We will help you compile the documentation required by law and by the MDR. |
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Unauthorised health claims: On a food supplement you claim that it “reduces cholesterol” or “kills viruses”, which is contrary to EU regulations. |
We will review your packaging and marketing copy. We will propose wording that complies with the regulations so it can be sold and is safe. |
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Detention of goods: If you import goods from third countries and they lack, for example, notification in the CPNP or registration in the RZPRO, customs will not release the goods into circulation. |
We provide immediate legal assistance when a shipment is detained. We communicate with the customs office and supervisory authorities to secure the release of the goods or minimise losses. |
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Distributor liability: You think the foreign manufacturer is liable for defects, but as an importer into the EU you bear full legal responsibility. |
We will set up supplier contracts to protect your right of recourse for damages. We will explain your obligations under the applicable legislation for 2026. |
Which advertising puts you on the edge with SÚKL
The Advertising Regulation Act strictly penalises attributing medicinal properties to foods and cosmetics.
If you state for a gum cream that it “treats inflammation”, this is a risky medicinal claim, whereas wording such as “helps keep the mouth in good condition” is safe.
For vitamin C, it is safe to claim that it contributes to the normal function of the immune system. By contrast, claiming that the vitamin works as prevention against flu is prohibited for foods.
The attorneys of ARROWS, a Prague-based law firm, will help you set the wording so you can use the marketing potential without getting into conflict with the law.
What to do when an inspection arrives
If you are contacted by SÚKL, SZPI, KHS or ČOI on suspicion of a breach of regulations, you must act quickly.
Contact an attorney immediately, because deadlines in administrative proceedings are unforgiving.
Do not provide explanations without preparation, as an inappropriately chosen word may be used as evidence against you. It is necessary to analyse whether it is a formal error or a fundamental classification issue.
ARROWS, a Prague-based law firm, has experience in successfully defending clients in administrative and court proceedings against regulators.
FAQ
1. It’s natural, so it can’t be a medicine, right?
That is a misconception, because many medicines are of plant origin. If a herbal extract contains active substances at a therapeutic dose, it is a medicinal product and must be registered regardless of its natural origin.
2. SZÚ approved it— is that enough?
Be careful with terminology: SZÚ often carries out testing or issues safety assessments, but that is not an authorisation to sell. Responsibility for notification always lies with the responsible person, i.e., the manufacturer or the importer.
3. Is registration in another EU country sufficient?
For food supplements and cosmetics, the free movement of goods applies, but you must meet notification obligations and have a label in Czech. For medicinal products, there is no automatic recognition of registration without an official process, and even within the EU you must obtain a decision from SÚKL for the Czech market.
Final recommendation
Correct product classification is the cornerstone of your business. If you underestimate this step, you are building a business on an uncertain foundation with the risk of ruinous fines.
Given the complexity of European and Czech legislation in 2026, we recommend consulting your plan to place a product on the market with the lawyers at ARROWS, a Prague-based law firm.
We will help you assess the composition and intended use of the product and classify it under the correct regulatory regime. We will prepare labels so they are legally safe, and we will represent you in dealings with the authorities.
Disclaimer: The information contained in this article is for general informational purposes only and serves as a basic guide to the issue as of 2026. Although we strive for maximum accuracy, laws and their interpretation evolve over time. We are ARROWS Law Firm, a member of the Czech Bar Association (our supervisory authority), and for the maximum security of our clients, we are insured for professional liability with a limit of CZK 400,000,000. To verify the current wording of the regulations and their application to your specific situation, it is necessary to contact ARROWS Law Firm directly (office@arws.cz). We are not liable for any damages arising from the independent use of the information in this article without prior individual legal consultation.
Read also:
- Key Healthcare, Pharma and Food Law Changes in the Czech Republic and EU in 2026
- Dietary Supplements vs Medicinal Products in Czech Law: Key Compliance Steps
- Food Supplements vs Medicinal Products: Avoiding Reclassification in Czechia
- Dietary supplement vs. medicine vs. novel food Comparison and differentiation
- THC and CBD Products in the Czech Republic and EU: Key Legal Risks and Rules