Legal Requirements and SÚKL Inspections for Online Pharmacies in Czechia

Selling pharmaceuticals online may seem straightforward, but it involves numerous legal risks under Czech law. The State Institute for Drug Control (SÚKL) monitors every step, from the authorization to operate a pharmacy to the specific products offered. If you believe that simply offering the same medications as a brick-and-mortar pharmacy online is sufficient, you risk substantial fines. In this article, our Prague-based legal team explains how regulatory oversight works and how to operate safely within this highly regulated environment in the Czech Republic.

Quick Summary

• Mail-order dispensing of medicines is subject to strict regulation by SÚKL (State Institute for Drug Control) and must not begin without prior notification. Reporting must be submitted at least 15 days before commencing activities. Illegal activity carries a fine of up to 20 million CZK under Czech law.
• You may only sell a defined range of products; prescription-only medicines (Rx) are prohibited for mail-order dispensing. Only registered medicinal products not bound by medical prescription can be sold. SÚKL actively identifies violations through website monitoring in the Czech Republic.
• Inspections can be conducted remotely and are comprehensive. SÚKL monitors your website content, available products, advertising, and terms and conditions.
• Proper preparation and legal advice minimize risks. Our attorneys in Prague at ARROWS regularly handle cases in this sector and can help you avoid sanctions.

What SÚKL inspects at e-commerce retailers

Assuming that SÚKL simply checks whether you are selling registered medicines is a fundamental mistake. In practice, it is a supervisory system that affects every aspect of your online business in the Czech Republic. When inspecting online pharmacies, SÚKL examines at least five basic areas.

These include technical aspects of the website, the range of medicinal products offered, advertising content, documentation, and compliance with the requirements of the Czech Act on Pharmaceuticals. Inspectors focus in detail on the content of your website, which medicines you offer, what information you publish about them, how you promote them, and how you handle them.

Every word appearing on your website can be subject to analysis, especially if it could be interpreted as unauthorized advertising or misleading claims about therapeutic effects. Your legal status and whether your terms and conditions are correctly set up under Czech commercial law are also routinely checked.

The authority verifies how you maintain order records and whether you adhere to shipping deadlines, which are generally within 48 hours. What seems like a mere technical obligation means, in practice, that SÚKL assesses hundreds of documents and records during an inspection. Our Czech legal team at ARROWS can prepare you for this oversight and ensure all your documentation is in order.

Legislative framework for mail-order dispensing of medicines

The fundamental legal regulation is the Czech Act on Pharmaceuticals, which has been harmonized with European legislation and precisely stipulates how medicinal products should be sold in the online environment. Furthermore, pharmacy e-commerce is subject to rules from the Act on Regulation of Advertising and general consumer rights based on the Czech Civil Code.

Many entrepreneurs do not realize that each of these legal regulations brings its own set of obligations and sanctions. If you violate advertising rules, you face a fine of up to 5 million CZK, and in the case of illegal pharmacy operation, sanctions can reach up to 20 million CZK.

In practice, this is an interconnected system of rules where a mistake in one area usually implies errors in others. Therefore, the Prague-based attorneys at ARROWS recommend a comprehensive legal audit of your business before you venture into the online sale of medicines.

Obligations of online pharmacies

An online pharmacy is not just a standard e-shop; it is an extension of a physical pharmacy's services into the online space. Mail-order dispensing can only be operated by the operator of a brick-and-mortar pharmacy, and therefore it is subject to strict obligations. You must publish information about mail-order dispensing and display the common EU logo visibly on the website.

Furthermore, you must ensure transport in a way that prevents the degradation of medicinal products, maintain complete order documentation, and ensure the availability of an information service. Additionally, you may not sell all types of medicines, as prescription-only medicines may not be sold via mail-order at all under Czech legislation.

Over-the-counter medicines can be sold, but only if they are registered in the Czech Republic or centrally in the EU. If you think you can expand your range with a similar medicine from abroad that is not listed in the SÚKL database, you risk not only a fine but also the withdrawal of products from the market.

Another critical obligation is ensuring safe storage and transport. As a pharmacy operator, you are fully responsible for ensuring that medicinal products are not exposed to frost, excessive heat, or other influences that could damage them during delivery.

Registration and reporting to SÚKL

This is the first and most frequently misinterpreted obligation. Without notifying SÚKL, you cannot legally commence mail-order dispensing of medicines, and this is not an optional step.

The law sets a clear deadline for all operators. A pharmacy operator is obliged to notify SÚKL of the commencement of mail-order dispensing at least 15 days in advance.

You must fill out a specific form available on the SÚKL website and submit it to the institute. Many entrepreneurs believe that if they have a pharmacy and an e-shop, they are set, but if you fail to comply with the notification obligation, you are committing an administrative offense.

SÚKL maintains a public list of all pharmacies authorized for mail-order dispensing in the Czech Republic. If you are not listed there, your activity is considered illegal, and the consequences can be fatal.

Our attorneys in Prague at ARROWS commonly handle situations where clients began selling without proper notification or where their notification proved to be incomplete. We recommend seeking assistance with the preparation and submission of the report to ensure all legal requirements are met.

Related FAQ - Registration and obligations of online pharmacies

1. If I am an individual and want to sell medicines online, can I open an e-shop without a brick-and-mortar pharmacy?
No. Mail-order dispensing of medicines in the Czech Republic can only be performed by the operator of a "brick-and-mortar" pharmacy (a pharmaceutical care health facility) that holds a permit from the regional authority and registration with SÚKL. Independent online sales without a link to an approved pharmacy are illegal.

2. What documents do I need to have ready when I want to report the start of mail-order dispensing?
You must complete the notification form available on the SÚKL website and submit it at least 15 days before starting the activity. The form includes the identification of the pharmacy, the start date of the activity, and the web address where the dispensing will be offered.

3. What happens if I forget about SÚKL and just start selling?
SÚKL will likely detect you during internet monitoring or based on a tip-off. You would be violating the Czech Act on Pharmaceuticals. You face administrative proceedings and a fine that can range from hundreds of thousands to millions of CZK depending on the severity and scope of the violation.

Illegal sales and fraud – what SÚKL actively monitors

Although the legal sale of pharmaceuticals is strictly regulated, the State Institute for Drug Control (SÚKL) focuses significantly on combating illegal sales and the offering of counterfeits. The Institute cooperates with customs, the police, and international agencies, maintaining teams that monitor websites and advertisements.

What specifically does SÚKL monitor? The Institute monitors websites that sell unregistered pharmaceuticals, counterfeits, and dietary supplements with misleading medicinal claims.

The second major area is advertising, where SÚKL very closely monitors how you promote products. If you claim in your advertisement for a dietary supplement that it treats high blood pressure or diabetes, you are violating Czech law. For pharmaceuticals, you must not promise guaranteed effects or target advertising at children.

Words like "cures," "heals," or "guaranteed to eliminate" used for dietary supplements are a signal for inspectors. If you sell pharmaceuticals for which you cannot prove the origin from an approved distributor, SÚKL will detect this during an inspection of stock records.

Attorneys from the ARROWS law firm in Prague regularly handle cases where clients, in good faith, used inappropriate phrasing in advertising or on their website. Consulting at this stage usually means the necessity to immediately correct the website and conduct negotiations with SÚKL.

Inspection in practice: what happens when SÚKL initiates an inspection

The perception of how SÚKL conducts inspections of online pharmacies often differs from reality for many entrepreneurs. SÚKL frequently utilizes so-called mystery shopping and remote monitoring.

In practice, inspectors will view your website, check the product range, and compare it with the database of registered pharmaceuticals. Inspectors will review your website, check the assortment, examine the content of product cards, and verify the presence of a functional common logo.

They may perform a mystery purchase to verify compliance with shipping conditions and information obligations. Furthermore, they will request your terms and conditions, complaints procedure, and documentation regarding storage and transport. An inspection can last weeks or even months, and SÚKL may request additional information.

If discrepancies appear, such as advertising in violation of the law or the sale of medicines not intended for the Czech market, a problem arises. If discrepancies are found, SÚKL will initiate administrative offense proceedings.

As part of the proceedings, you will receive a notice of initiation of proceedings or an order, where many entrepreneurs get into trouble because they underestimate the situation. Legal proceedings are formalized and deadlines are strict. An inappropriately formulated response can be used against you.

The ARROWS law firm in Prague commonly represents clients during these inspections and proceedings. Our experience shows that legal assistance in the early stages can lead to better outcomes and the minimization of sanctions.

Related Queries - SÚKL Procedures and what to do during an inspection

1. Do I have to cooperate with SÚKL if they request information during an inspection?
Yes. The inspected person has an obligation to provide cooperation. If you do not provide the information, you face a fine for obstructing the inspection. However, we always recommend consulting the scope and form of responses with a lawyer.

2. What is the usual duration of an inspection?
The length varies according to complexity. SÚKL will prepare an inspection report, against which you can file objections. The entire process, including any administrative proceedings regarding a fine, can take several months.

3. What happens if I disagree with SÚKL's findings?
You have the right to file objections against the inspection findings within the period specified in the report (usually 15 days). If administrative proceedings are initiated and a fine is imposed, you can file an objection or an appeal. Professional legal argumentation is key to success in these steps.

Typical mistakes that cost millions of crowns

In our work with online pharmaceutical sellers at the ARROWS law firm, we have seen many cases that could have been prevented. Often it is a matter of underestimating the situation or ignorance of detailed Czech regulations.

The first mistake is relying on the fact that if a competitor is doing something, it must be fine. The fact that a competitor is breaking the law does not mean it is legal. SÚKL proceeds systematically, and when your turn comes, this argument will not protect you.

The second common mistake is neglecting documentation and logistics. You must be able to document the journey of every package of medicine to the end customer. If your records are not in order or you do not have a contract with a carrier guaranteeing the temperature regime, it is a serious deficiency.

The third mistake is confusing dietary supplements and pharmaceuticals in advertising. Stating that a dietary supplement heals is prohibited, and these transgressions are strictly punished. For pharmaceuticals, you must adhere to the exact formulations approved during registration.

The fourth mistake is ignoring changes in legislation, as legal regulations evolve and what applied years ago may not apply today. A regular legal audit is an essential preventive measure, and we recommend a legal review to clients even before launching a project. Attorneys from ARROWS can help you set up processes to minimize the risk of sanctions under the Czech legal system.

MicroFAQ: Most common mistakes and their solutions

1. What is considered a prohibited medicinal claim?
For food and dietary supplements, it is prohibited to attribute properties of prevention, treatment, or cure of human diseases, or to refer to such properties. For example, the sentence "this tea cures the flu" is inadmissible. For pharmaceuticals, claims must be in accordance with the Summary of Product Characteristics (SPC).

2. Who is responsible for medicines during transport?
The pharmacy operator. Even if you use an external courier service, you bear the responsibility for quality toward the patient and SÚKL. You must ensure that the carrier complies with established conditions, such as temperature and packaging integrity.

3. Is a standard email sufficient for communicating with SÚKL?
For formal submissions, such as notifications or objections, specific legal forms must be followed under Czech law. Ideally, you should communicate via a data box (datová schránka) or by email with a recognized electronic signature. Legal entities are required by Czech legislation to communicate primarily via data box.

Advertising oversight – what SÚKL actually monitors

Advertising for human medicinal products is strictly regulated in the Czech Republic, and SÚKL can impose fines on legal entities of up to 5 million CZK for violations. SÚKL monitors not only websites but also social media, newsletters, and PR articles.

What does SÚKL look for in advertising? Primarily, any inconsistency with the Summary of Product Characteristics (SPC). Advertising for over-the-counter (OTC) medicines must be clear, must not be misleading, and must contain mandatory information required under Czech regulations.

SÚKL also focuses on social media and influencers; if an influencer promotes a medicine without disclosing the partnership, the responsibility may also fall on the advertiser. Hidden advertising or posing as a cured patient is also punishable. Our Prague-based attorneys at ARROWS can provide a legal review of your marketing materials before publication, significantly reducing the risk of fines.

Conclusion

Pharmaceuticals in e-commerce are not standard goods; they belong to a highly regulated sector where every step is subject to oversight. SÚKL has broad powers and actively exercises them to protect public health in the Czech Republic.

Errors in this field can be devastating. There is a risk of multi-million CZK fines, bans on activity, and reputational damage. Czech legal regulations are complex, and their interpretation continues to evolve.

Our Czech legal team at ARROWS works proactively with clients to help set up business operations in a way that avoids these issues. We have extensive experience in both Czech pharmaceutical law and e-commerce.

If you operate or plan to launch an online sale of medicinal products, do not hesitate to contact us. Simply write to us at office@arws.cz and we will help you create a secure legal framework for your business.

FAQ – Frequently asked legal questions regarding pharmaceuticals in e-commerce

1. Can I buy medicines abroad and sell them in the Czech Republic online?
No, unless you are an authorized distributor and the medicinal product is registered in the Czech Republic (or centrally in the EU) and intended for the Czech market (with Czech packaging and patient information leaflets). Parallel imports are subject to a special permit from SÚKL.

2. As an individual, can I sell surplus medicines online?
No. The sale of medicines may only be carried out by an authorized pharmacy. Selling medicines "hand-to-hand" or via classified ad portals is illegal and carries high fines (for individuals, up to millions of CZK for larger-scale sales, or potential criminal prosecution under the Czech criminal code).

3. What is the difference between a medicinal product and a dietary supplement?
A medicinal product undergoes a registration process with SÚKL, must prove efficacy and safety, and has therapeutic effects. From a legislative perspective, a dietary supplement is a foodstuff that supplements the diet and must not declare therapeutic effects. The regulation of sales and advertising differs for both categories under Czech law.

4. What should I do if SÚKL initiates an inspection?
Do not panic, but act quickly. Provide cooperation to the required extent, but simultaneously contact an expert in Czech pharmaceutical law. The ARROWS law firm in Prague will help you formulate responses and your defense strategy.

5. What are the basic steps for a legal e-shop with medicines?
You must be the operator of a brick-and-mortar pharmacy and notify SÚKL of your intent to conduct mail-order dispensing 15 days in advance. Furthermore, ensure that the medicines offered are registered, available over-the-counter, and that your logistics are set up correctly. You should also have your website and terms and conditions legally reviewed; for professional setup, contact office@arws.cz.

Disclaimer: The information contained in this article is for general informative purposes only and serves as a basic guide to the issue. Although we ensure maximum accuracy of the content, legal regulations and their interpretation evolve over time. To verify the current wording of regulations and their application to your specific situation, it is essential to contact our Prague-based attorneys at ARROWS directly (office@arws.cz). 

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