SÚKL Inspections: Key Red Flags for Pharmacies and Drug Distributors

JUDr. Jakub Dohnal, Ph.D., LL.M.
JUDr. Jakub Dohnal, Ph.D., LL.M.
18.3.2026 | ARROWS law firm

Do you operate a pharmacy, distribute medicinal products, or are medicinal products and medical devices part of your business? If so, it is essential to understand what the State Institute for Drug Control (SÚKL) in the Czech Republic, as well as other supervisory authorities, focus on. Your business operates in one of the most strictly regulated environments under Czech law, where details can make the difference between lawful operation and fines reaching millions of Czech crowns. In this article, you will learn which specific signals may attract regulators’ attention and how to recognise when your product or process is at risk.

The illustrative image shows a specialist during a consultation regarding an inspection by the State Institute for Drug Control (SÚKL).

Quick summary

  • An illegal medicine is not only a counterfeit product; from a legal perspective, it can be anything that breaches the rules of the Czech Act on Medicinal Products.
  • SÚKL (the Czech State Institute for Drug Control) and other authorities actively monitor websites, social media and business activities, and an inspection may take place without warning.
  • The most common triggers for an inspection include the sale of unregistered products, illegal distribution channels and tampering with safety features.
  • The attorneys at ARROWS, a Prague-based law firm, deal with these regulatory risks on a daily basis and can assist you with an audit of your approach.

What is meant by illegal handling of medicinal products

When we hear the term “illegal medicine”, the public often imagines a counterfeit product or a purchase on the black market. For businesses, however, the reality is more complex. From a legal perspective under Czech law, even a completely original medicinal product may be problematic if it is not registered in the Czech Republic, or if it is handled in breach of the law. This may include, for example, sales through channels not permitted by law, or exports of medicines that threaten their availability for Czech patients.

Act No. 378/2007 Coll., on Medicinal Products, as amended, sets strict rules on how medicinal products may be placed on the market, distributed and dispensed in the Czech Republic. Breaching these rules exposes you to the risk of penalties, regardless of whether you acted in good faith. In practice, many businesses do not realise that even seemingly minor decisions can have serious legal consequences.

SÚKL carries out systematic supervision, including monitoring websites, e-shops and social media. The attorneys at ARROWS, a Prague-based law firm, encounter these issues regularly and can identify risk areas (compliance gaps) that would otherwise lead to the initiation of misdemeanour (administrative offence) proceedings. It is therefore important to know the following five red flags that regulators monitor closely.

Red flag No. 1: Sale of unregistered medicinal products

A common mistake is when a business starts placing on the Czech market a medicinal product that is not registered in the Czech Republic. It may be a medicine that is legal abroad, but without a valid registration for the Czech market. The mere fact that it is an original pack with a foreign-language label does not mean that its sale in the Czech Republic is legal.

The Czech Act on Medicinal Products establishes the principle that only registered medicinal products may be used in the Czech Republic. If you do not comply with this condition and place an unregistered medicine on the market, you commit an administrative offence. During an inspection, SÚKL verifies registration in its database, and the absence of registration or authorisation of a specific treatment programme leads to sanctions.

Registration of a medicine guarantees that the product has undergone an assessment of safety, efficacy and quality. By selling an unregistered medicine, the seller assumes enormous risk. Not only is there a risk of a fine of up to CZK 20 million, but in the event of harm to health, the seller may also face criminal liability.

Related questions

1. How can I verify whether a medicine is registered?
A registered medicinal product is assigned a SÚKL code and is listed in the medicines database available on the SÚKL website. The packaging must state the registration number.

2. Does registration from another EU country automatically apply?
Not automatically. If a medicine has a so-called centralised (EU) marketing authorisation, it is valid in the Czech Republic as well. However, if it only has a national authorisation in another Member State, it may not be freely sold in the Czech Republic without the relevant approval from SÚKL.

3. Can I sell a medicine purchased in the EU in its original packaging?
No, not without the relevant distribution authorisation and, where applicable, a parallel import authorisation. A medicine placed on the Czech market must generally have packaging and a patient information leaflet in the Czech language.

Red flag No. 2: Trading outside official distribution channels

The second red flag that regulators monitor closely is the sale of medicines outside approved distribution chains. This includes sales between patients, sales via unauthorised classified-ad portals, or illegal mail-order dispensing.

In the Czech Republic, a fundamental rule applies to online sales. Only medicinal products that are not subject to a prescription may be dispensed via mail-order (e-shop) dispensing. Prescription-only medicines (Rx) may not be sent to patients by post or courier; they must be dispensed in person at a pharmacy.

Offering medicines on platforms such as online marketplaces or classified-ad websites is illegal. Pharmacy operators who wish to provide mail-order dispensing must notify SÚKL no later than 15 days before starting this activity. SÚKL regularly checks e-shops and focuses on whether they offer only the permitted assortment.

The attorneys at ARROWS, a Prague-based law firm, provide legal support when setting up pharmacy e-shops and represent clients in administrative proceedings in the Czech Republic. Properly setting business terms and processes is key to avoiding sanctions.

Related questions

1. Can I offer prescription medicines on an e-shop?
No, mail-order dispensing of prescription-only medicines is prohibited in the Czech Republic. You may only allow a reservation of a prescription medicine (ePrescription) with subsequent personal collection at the pharmacy.

2. What is mail-order dispensing?
It is the dispensing of medicinal products based on an order via mail-order means (internet, telephone). Only approved brick-and-mortar pharmacies may carry out this activity after notifying SÚKL.

3. What is the penalty for illegal sale of medicines on a classified-ad website?
For an individual, this is an administrative offence with a sanction in the tens to hundreds of thousands of CZK. If the activity shows signs of unauthorised business activity on a larger scale, it may constitute a criminal offence.

Red flag No. 3: Tampering with safety features

As part of the fight against counterfeits (the FMD Directive), most medicinal products must have safety features on the packaging. These consist of a unique identifier in the form of a 2D Data Matrix code and an anti-tampering device. This system makes it possible to verify the authenticity of each individual pack.

If, in a pharmacy or distribution, a situation arises where the safety features are missing, damaged, or the system reports an error during verification, suspicion arises. During inspections, SÚKL checks compliance with the obligation to verify and decommission codes in the system (decommissioning). Tampering with these codes or ignoring them is a serious administrative offence.

Distributors and pharmacies face sanctions if they fail to meet their obligations under the medicines authenticity verification system. Counterfeit medicines are often characterised by invalid or duplicate codes, which is why effective verification is essential.

Related questions

1. What should I do if the system reports an alert?
The pharmacist must follow the instructions of SÚKL (the Czech State Institute for Drug Control) and the repository management system. The medicine must not be dispensed to the patient, it must be isolated, and the cause of the alert must be investigated in cooperation with the marketing authorisation holder.

2. Am I at risk of a fine for unintentionally failing to decommission a code?
Yes, both pharmacies and distributors have a statutory obligation under Czech law to verify and decommission codes. Systematic errors may result in a fine.

Signal No. 4: Threats to availability and re-export of medicines

The export of medicines from the Czech Republic abroad (re-export) is a sensitive topic, limited by the need to ensure the availability of care for Czech patients. Since 2024, stricter rules under the Czech Act on Medicines have applied. These impose specific obligations on distributors and marketing authorisation holders in the event of medicine shortages.

A signal for SÚKL is a situation where a distributor exports medicines designated as products with limited availability. If a distributor exports a medicine whose export is currently prohibited or restricted by a measure of a general nature, they commit a serious administrative offence. SÚKL and the Czech Ministry of Health monitor medicine flows in great detail.

Distributors must also not prioritise exports over supplies to Czech pharmacies to an extent that would jeopardise the availability of care. ARROWS attorneys in Prague help distributors set up internal control mechanisms (compliance) to prevent breaches of export bans.

Related questions

1. Is re-export always illegal?
No. If the medicine is not on the list of medicines with limited availability and the distributor fulfils all notification obligations towards SÚKL, export within the EU is possible.

2. What are the sanctions for exporting a prohibited medicine?
Fines for breaching an export ban or failing to meet the obligation to supply Czech patients range into the millions of Czech crowns, and in serious cases up to CZK 20 million.

3. Can a pharmacy sell medicines to a distributor for the purpose of export?
A pharmacy may dispense medicines only to patients or other healthcare providers, not to distributors for the purpose of further resale.

Signal No. 5: Unlawful advertising of medicines

The fifth risk signal is advertising, which is subject to strict regulation under the Advertising Regulation Act. The supervisory authority is SÚKL, and the fine may reach up to CZK 5 million. Among the most common offences is advertising prescription-only medicines to the general public, which is strictly prohibited.

Another issue is unauthorised health claims and confusing food supplements with medicines. If you promote a food supplement and attribute therapeutic effects to it, you are breaching the law, because food supplements must not claim to treat.

SÚKL actively monitors the media and the internet. ARROWS, a Prague-based law firm, reviews marketing materials, websites and campaigns to ensure they comply with Czech law and do not expose the client to the risk of sanctions.

Related questions

1. Can I promote a prescription weight-loss medicine on social media?
No, this is strictly prohibited. Advertising of Rx products may target only professionals, i.e., doctors and pharmacists.

2. What fine applies for misleading advertising?
Up to CZK 5 million, depending on the seriousness and impact of the advertising.

3. What is the difference between advertising a medicine and a food supplement?
For a medicine, approved therapeutic indications may be stated. For a food supplement, you cannot state that it treats or prevents disease; only approved health claims under EU regulations are permitted.

What sanctions and fines may apply

If SÚKL or another authority identifies a breach of the law, administrative proceedings will follow. The level of fines is set by the Czech Act on Medicines and the Advertising Regulation Act and depends on the seriousness of the offence.

Overview of maximum fine levels:

  • Up to CZK 20,000,000 for the most serious offences, such as handling medicines without authorisation or illegal export.
  • Up to CZK 5,000,000 for breaches of the rules on advertising medicinal products.
  • Up to CZK 2,000,000 for less serious breaches of record-keeping obligations.

In addition to financial sanctions, there is also the risk of a ban on activity, suspension of a distribution licence or pharmacy operation, and withdrawal of the product from the market. Where there is suspicion of a criminal offence, the matter is handled by Czech law enforcement authorities, which can have fatal consequences for a business.

Risk

Sanction (maximum)

Role of ARROWS

Sale of an unregistered medicine

Fine up to CZK 20 million

Legal analysis of the portfolio.

Illegal export (threat to availability)

Fine up to CZK 20 million

Compliance audit of distribution processes.

Unlawful advertising

Fine up to CZK 5 million

Review of marketing texts and campaigns.

Illegal mail-order dispensing

Fine up to CZK 20 million

Setting e-shop terms and conditions in compliance with Czech law.

Manipulation of 2D codes (FMD)

Fine up to CZK 20 million

Advice on FMD compliance.

How to protect yourself in practice

Prevention is always cheaper than dealing with the consequences of an inspection. The legal environment in the pharmaceutical sector in the Czech Republic is complex and dynamic.

  1. Have your processes, contracts and product range reviewed by experts through a compliance audit.
  2. Pharmacy and distribution staff must know the current rules for dispensing and handling FMD codes.
  3. Ensure that all permits, operating rules, complaints procedures and inventory records are in order.
  4. In case of uncertainty or an ongoing inspection, do not communicate without legal advice.

ARROWS’ Czech legal team specialises in pharmaceutical law and helps clients set up their business so that it is safe and compliant with applicable legislation.

The role of SÚKL and other regulatory authorities

The State Institute for Drug Control (SÚKL) is the main supervisory authority in the Czech Republic. It carries out inspections of manufacturers, distributors and pharmacies and has the power to impose fines.

However, it cooperates with other authorities:

  • The Czech Customs Administration monitors .
  • The Police of the Czech Republic deal with criminal activity, such as counterfeits or drug production.
  • The Czech Agriculture and Food Inspection Authority (SZPI) monitors .

Conclusion

The issue of illegal medicinal products and compliance with the Act on Medicinal Products under Czech legislation is a high-risk environment for any entrepreneur in the sector. The line between lawful business and an administrative offence can be thin, especially in the areas of advertising or re-export. The five signals described in this article represent the most common reasons for high fines.

If you are not sure whether your operations meet all current requirements in the Czech Republic, it is time to contact experts. ARROWS advokátní kancelář offers the backing of a strong Czech legal team with professional liability insurance and, if needed, will provide you with an expert consultation at office@arws.cz.

FAQ – Most common legal questions

1. What should I do if I receive a notice of the commencement of an inspection from SÚKL (the Czech State Institute for Drug Control)?
Stay calm, but act quickly. Contact your legal representative, prepare the requested documentation, and cooperate with the inspectors, but do not provide information beyond your statutory obligations without prior consultation.

2. Is it legal for a pharmacy to have a social media profile?
Yes, a pharmacy may have a social media profile. However, it must be very careful about the content of its posts; it must not promote prescription-only medicines, and advertising of over-the-counter medicines must meet the statutory requirements under Czech law.

3. Can SÚKL shut down my pharmacy?
In extreme cases, yes. SÚKL may suspend operations or revoke the authorisation to provide pharmacy care if it finds serious and repeated breaches of the law that endanger public health in the Czech Republic.

4. How can I tell whether it is a dietary supplement and not a medicinal product?
A medicinal product has a SÚKL registration number on the packaging and the package leaflet states that it is a medicinal product. A dietary supplement is a food product and must bear the designation "dietary supplement".

Notice: The information contained in this article is of a general informational nature only and is intended for basic guidance based on the legal status as of 2026. Although we strive for maximum accuracy, legal regulations and their interpretation evolve over time. We are ARROWS advokátní kancelář, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client security we maintain professional liability insurance with a limit of CZK 400,000,000. To verify the current wording of regulations and their application to your specific situation, it is necessary to contact ARROWS advokátní kancelář directly (office@arws.cz). We accept no liability for any damages arising from the independent use of the information in this article without prior individual legal consultation.

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