Dietary Supplements vs Medicinal Products in Czech Law: Key Compliance Steps

Mgr. Dita Zbožínková, LL.M.
Mgr. Dita Zbožínková, LL.M.
11.3.2026 | ARROWS law firm

The legal regulation of dietary supplements and medicinal products in the Czech Republic is complex, and the line between them can be thin. The decision as to whether your product is subject only to notification with the Ministry of Agriculture, or requires registration as a medicinal product with SÚKL (the Czech State Institute for Drug Control), has a fundamental impact on your ability to sell legally. In this article, you will find clear answers to the questions every wellness business owner must ask.

The photo shows a lawyer consulting on the legal regulation of dietary supplements.

Quick summary

  • The difference between notification and registration : Notification is an information obligation towards the Czech Ministry of Agriculture for food supplements placed on the market in the Czech Republic. By contrast,  is required if the product has medicinal properties or contains pharmacologically active substances.
  • High risks : Selling a medicinal product disguised as a food supplement without registration is a serious offence under Czech law. You may face fines of up to CZK 20 million, product withdrawal from the market, and criminal liability.
  • Practical complexity : Determining whether your product falls under the Czech Food Act or the Czech Medicines Act depends on its composition, dosage, function, and also how the product is presented.
  • Time efficiency : The Czech legal team at ARROWS law firm in Prague handles this agenda on a daily basis and will guide you through the process so that you comply with all statutory obligations in the Czech Republic.

What a food supplement is and why correct classification matters

Under Act No. 110/1997 Coll., on Food and Tobacco Products, a food supplement is defined as a food intended to supplement the normal diet. It is a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect. The key point is that a food supplement does not treat or prevent diseases; it only supports normal bodily functions.

By contrast, a medicinal product has properties to treat or prevent diseases, or to affect physiological functions through a pharmacological effect.

The key question is: is your product truly only a supplement, or does it meet the definition of a medicinal product under Czech law? The decision is not trivial. In practice, we encounter so-called borderline products, where even a minor change in packaging wording or a slightly higher dosage of an active substance can shift the product’s legal regime from “food” to an “illegally marketed medicinal product”.

The attorneys at ARROWS law firm in Prague deal with product classification on a daily basis and know how to avoid mistakes that can lead to crippling fines imposed by the Czech State Agricultural and Food Inspection Authority (SZPI) or SÚKL.

Notification to the Ministry of Agriculture – a requirement for food supplements

If it is a food supplement, you must fulfil the notification obligation (filing) with the Czech Ministry of Agriculture (MZe). Under Section 3d of the Czech Food Act, the food business operator is required to send the Ministry the Czech-language label text. You must comply with this obligation no later than before the first placing of the food supplement on the market in the Czech Republic.

Notification is not an approval process; it is the fulfilment of an information obligation, where the authority does not approve the product in advance but acknowledges its placing on the market.

For notification and placing on the market, you must ensure:

  • A Czech-language label : It must contain the mandatory information under  and Decree No. 58/2018 Coll. (e.g., name, composition, recommended dosage, warnings).
  • Notification to MZe : Submission of the label text (typically electronically / via a data box).
  • Health safety : The product must be safe.
  • Compliance with limits : Some substances (e.g., vitamins, minerals) have set limits. Other substances may be prohibited (see  and EU regulations).

The act of notification itself is not subject to an administrative fee; however, costs arise from expert preparation of labels and assessment of the composition. If you omit notification, you commit an administrative offence, which may result in a fine and, above all, attention from supervisory authorities.

The attorneys at ARROWS law firm in Prague can prepare the supporting documents and review your labels for you, minimizing the risk that the product will be withdrawn from the market at the first inspection due to formal deficiencies.

Related questions on notification

1. When do I have to notify?
The obligation arises before the first placing on the market. This means that at the moment you offer the product for sale (e-shop, counter sale), the notification must already have been sent to the Czech Ministry of Agriculture.

2. Who notifies?
The obligation lies with the food business operator that places the food on the market in the Czech Republic (manufacturer, importer, or distributor under its own brand).

3. What happens if I do not notify?
You expose yourself to the risk of a fine from SZPI. The absence of notification is easily verifiable in the register and often triggers an in-depth inspection of your entire business.

Registration with SÚKL – when it is required

The Czech State Institute for Drug Control (SÚKL) does not issue “licences” for individual food supplements; it decides on the registration of medicinal products. If your product meets the definition of a medicinal product under Czech law, you must not sell it as a food supplement.

Registration of a medicinal product is necessary if the product meets the definition of a medicinal product or is presented as such.

Registration is required in the following cases:

  • Product by presentation : If you label the product with claims that it treats, alleviates, or prevents diseases, it becomes a medicinal product from a legal perspective.
  • Product by function : If the product contains substances in an amount that significantly affects physiological functions through a pharmacological effect, it is considered a medicinal product.
  • Content of specific substances : Some herbs or substances are considered exclusively medicinal and must not be included in food supplements.

The medicinal product registration process is extremely demanding and takes months to years. It requires clinical studies or bibliographic data, pharmaceutical manufacturing quality (GMP), and payment of high administrative fees. Overall development and documentation costs often run into millions.

If you are unsure whether your product falls under SÚKL, ARROWS law firm in Prague will provide you with a qualified legal assessment.

Related questions on the SÚKL regime

1. How do I identify a borderline product?
SÚKL issues lists of substances and opinions. If a substance has a strong pharmacological effect or is historically perceived as a medicine, the risk of reclassification is high.

2. Can I sell a “medicinal” product as a supplement if I do not make any claims?
Not necessarily. If the product functions as a medicine (has a pharmacological effect based on the concentration of substances), it is a medicinal product regardless of what you write on the packaging.

3. What are the sanctions for selling an unregistered medicinal product?
The fine under the Czech Medicines Act can reach up to CZK 20,000,000. At the same time, such conduct may be classified as a criminal offence of endangering health through harmful foodstuffs and other items.

Health claims – prohibited and permitted

For food supplements, the use of health claims is strictly regulated by Regulation (EC) No 1924/2006. This is the most common reason for fines imposed by the Czech Agriculture and Food Inspection Authority (SZPI) in the Czech Republic.

Prohibited claims are those that attribute to a food supplement properties of preventing, treating, or curing human diseases (e.g., “treats arthritis”, “stops the flu”). For foods, this is an absolute taboo under Czech and EU rules.

Permitted claims are only those approved by the European Commission and listed in the EU register. An exception is so-called “on-hold” claims for plant substances (botanicals), which have not yet been decided on but may be used under certain conditions.

The difference between “contributes to the normal function of the immune system” and “boosts immunity against viruses” is legally fundamental. The former is lawful marketing, the latter is grounds for initiating administrative proceedings in the Czech Republic.

Related questions on health claims

1. Where can I find permitted claims?
In the EU Register of Health Claims maintained by the European Commission. For herbs, you also need to check the so-called on-hold list.

2. What happens in case of a breach?
SZPI typically imposes fines in the tens to hundreds of thousands of CZK; for repeated offences or misleading practices, the fines can reach millions. In addition, you may have to relabel packaging or dispose of stock.

3. Can I use customer references (testimonials)?
Even customer testimonials on your website must comply with the rules on health claims. If a customer writes “it cured my eczema” and you publish it, you are the one breaching the law under Czech legislation.

Practical decision-making framework

In practice, we recommend the following approach:

  1. Composition analysis : Are the substances used permitted in food supplements under Czech and EU rules? Are they substances considered medicinal products or narcotic substances?
  2. Novel Food check : Is the ingredient a “novel food” under ? If yes, it requires a complex authorisation before being placed on the market.
  3. Purpose and claims : How do you want to present the product? If you target ill people, you will likely need a medicinal product registration.
  4. Notification : If it is a food supplement, prepare the label in accordance with the regulations and submit the notification to the Ministry of Agriculture (MZe) in the Czech Republic before launching sales.

Investing in a legal analysis before launching sales is a fraction of the cost compared to withdrawing a product from the market and rebranding. Contact us at office@arws.cz.

Risks and sanctions

How ARROWS helps (office@arws.cz)

Lack of notification: Selling without notifying (notification) the Ministry of Agriculture (MZe) is a breach of the Czech Food Act. You face a fine and increased oversight by SZPI.

Comprehensive compliance: We will ensure a review of mandatory requirements and proper completion of the notification so that your market entry in the Czech Republic is smooth.

Sale of an unregistered medicinal product: If you sell a “supplement” that is in fact a medicinal product, you face a fine of up to CZK 20 million from the State Institute for Drug Control (SÚKL) and criminal prosecution.

Classification and defence: We will analyse the borderline product. In the event of a dispute with SÚKL or SZPI, our Prague-based attorneys will represent you in administrative proceedings.

Unauthorised health claims: Using unapproved claims or medicinal claims leads to fines from SZPI (up to CZK 50 million depending on severity; in practice, hundreds of thousands).

Label and marketing audit: We will review packaging, your e-shop and advertisements to ensure compliance with Regulation No 1924/2006 and the Czech Advertising Regulation Act.

Novel Foods: Using an ingredient not approved in the EU (e.g., certain exotic herbs, CBD in foods) results in an immediate sales ban.

Novel Foods verification: We will verify the status of ingredients in the European Commission’s catalogue and advise whether the substance can be sold in the EU as a food.

SZPI inspection: Inspections take place without prior notice. Incorrect labelling, missing HACCP, or misleading consumers are penalised strictly under Czech law.

Representation during inspections: We provide legal support during inspections, formulate objections for the inspection record, and protect your rights.

European dimension – what is changing

EU legislation is constantly evolving. In the area of food supplements, there is an increasing emphasis on the safety of so-called “Novel Foods” and on harmonising maximum limits for vitamins and minerals. If you plan to export, you must take into account that notification obligations differ across EU Member States.

The attorneys at ARROWS advokátní kancelář have experience with cross-border matters and will help you set up compliance not only for the Czech Republic, but also for expansion into other EU markets.

Conclusion

Deciding whether you are placing a food supplement or a medicinal product on the market is a key strategic and legal step. A mistake at this stage can be fatal to your entire business plan.

The team at ARROWS advokátní kancelář deals with this agenda on a daily basis; we know how to communicate with SZPI and SÚKL and how to set up your business so that it is safe under Czech law.

Simply email us at office@arws.cz and we will help you with the legal assessment of your specific product. ARROWS advokátní kancelář carries professional liability insurance in the hundreds of millions of CZK, which is why it is safe for you to entrust your legal matters to us.

FAQ – Most common legal questions

1. What is the difference between notification and registration?
Notification is the fulfilment of an information obligation towards the Ministry of Agriculture for food supplements (foods) in the Czech Republic. Registration is an authorisation process with SÚKL for medicinal products, where efficacy, quality and safety must be demonstrated.

2. Can I notify only after sales have started?
The Czech Food Act requires submission of the Czech-language label text before the first placing on the market. Late notification is a formal breach of the law.

3. How much does notification cost and how much does medicinal product registration cost?
Notification to the Ministry of Agriculture (MZe) is exempt from an administrative fee (you only pay your own preparation costs). Medicinal product registration with SÚKL is subject to administrative fees in the tens to hundreds of thousands of CZK, and the total dossier costs are many times higher.

4. How do I know whether my ingredient has “Novel Food” status?
By checking the Union List of Novel Foods and the Novel Food Catalogue on the European Commission’s website. If the ingredient was not consumed to a significant degree in the EU before May 1997, it is likely a novel food requiring authorisation. To be safe, contact us at office@arws.cz.

5. What are the risks of using medicinal claims for a food supplement?
This constitutes misleading consumers and a breach of the Czech Food Act as well as EU regulation. You face high fines from SZPI, a sales ban, and the need to withdraw products.

6. Can you represent me during an SZPI inspection?
Yes. ARROWS advokátní kancelář offers representation during inspections, preparation of objections against inspection findings, and defence in administrative proceedings regarding fines. Contact us at office@arws.cz.

Notice: The information contained in this article is of a general informational nature only and is intended to provide basic guidance on the topic under Czech law. Although we strive for maximum accuracy, legal regulations and their interpretation evolve over time. To verify the current wording of the relevant regulations and their application to your specific situation in the Czech Republic, it is therefore necessary to contact ARROWS, a Prague-based law firm, directly (office@arws.cz). We accept no liability for any damages or complications arising from the independent use of the information in this article without our prior individual legal consultation and professional assessment. Each case requires a tailored solution, so please do not hesitate to contact us.

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