SÚKL Inspections
Key Red Flags for Pharmacies and Drug Distributors
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.
Key takeaways
Article contents
What is meant by illegal handling of medicinal products
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.
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.
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.
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.
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.
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.
- Have your processes, contracts and product range reviewed by experts through a compliance audit.
- Pharmacy and distribution staff must know the current rules for dispensing and handling FMD codes.
- Ensure that all permits, operating rules, complaints procedures and inventory records are in order.
- 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 consultation@arws.cz.
Read also:
- Key Healthcare, Pharma and Food Law Changes in the Czech Republic and EU in 2026
- Who Is Really Liable in the Czech Republic When the Company Gets Fined: The Firm or the CEO?
- Can I Be Personally Liable as a Director of a Czech Company?
- Dietary Supplements vs Medicinal Products in Czech Law: Key Compliance Steps
- Launching a Clinical Trial in the Czech Republic: Key Legal Requirements
About the author
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 (consultation@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.