Když zaklepe SÚKL

A specific and high-risk area is the supervision of advertising for medicinal products. Many marketing agencies or website operators are not even aware that their activities fall under the strict supervision of the SÚKL (State Institute for Drug Control).

Moreover, inspectors don't just arrive based on a pre-set annual plan. Increasingly, the SÚKL conducts inspections based on a specific tip-off. This tip-off could be a patient's complaint, but also a report from a disgruntled employee or a competitor. Your business dispute can thus very quickly turn into a problem with the state administration.

Are you unsure whether the strict SÚKL rules also apply to your business model, for example, your new e-shop or marketing campaign? Our Prague-based legal team at ARROWS can provide you with a quick legal analysis. Write to us at consultation@arws.cz.

The On-Site Inspection Process: "Hello, we're from the SÚKL..."

The inspection itself is a formal process. It begins with the inspectors presenting their "authorisation to inspect" and their official "inspector's ID". At this moment, the inspection is initiated. The inspectors' rights under Czech legislation are very broad. They have the right to enter all premises related to the subject of the inspection, demand the submission of any data and documents, make copies or image recordings, and even use your equipment (such as an internet connection). 

Your basic duty is to allow the inspection to be carried out and to provide the inspectors with the necessary cooperation. However, this does not mean you have to surrender and stop working. What if the inspectors arrive unannounced (which the SÚKL commonly does) and you have a waiting room full of patients? You do not have to immediately interrupt the provision of healthcare. The Act on Health Services explicitly states that the performance of an inspection must not disrupt the provision of health services.

You have the right to politely inform the inspectors of the situation and ask them to wait for an operational break or until the end of your office hours to conduct the inspection. It is in these tense moments that having legal support on the phone is crucial. Our lawyers are ready to represent you in dealings with the authorities from the very first minute. For immediate assistance, write to us at consultation@arws.cz.

The Achilles' Heel of Companies: Where the SÚKL Finds the Most Errors (and Imposes the Highest Fines)

Based on statistics and our experience, it is clear that the SÚKL does not impose the highest fines for "bad medicine," but for "bad administration." Operational shortcomings and missing documentation are by far the most common reasons for initiating administrative proceedings. The good news is that these risks are fully controllable.

1. Inadequate Documentation

SÚKL statistics are relentless. In one inspection campaign, "missing or inadequately prepared standard operating procedures" were found in 67.5% of the inspected facilities. Nearly two-thirds of companies then had deficiencies in their records of complaints and product recalls.

Inspectors most often find errors or a complete lack of documentation in these areas:

• Storage and preservation of medicinal products.

• Missing temperature control records (in the warehouse or refrigerator).

• Expiry date control (expired medicines are not physically segregated).

• Records and disposal of unusable medicinal products.

• Keeping records of narcotic substances (the so-called "opiates register").

• Missing written "job descriptions" for individual employees.

Missing documents are a clear signal to a SÚKL inspector that basic processes are not functioning within the company. The lawyers at ARROWS specialise in preparing compliance documentation. We will prepare auditable documentation and internal policies for you that will protect you from fines. Write to us at consultation@arws.cz.

2. Medical Devices: The Manufacturer's Paperwork Isn't Everything

The inspection covers not only medicines but also all equipment – from diagnostic devices to dental chairs. The inspector will look for the "Declaration of Conformity," instructions in the Czech language, and for more complex devices (Class II.b and III.), also the installation and operator training records.

But the biggest trap is servicing. Operators often rely on having a valid inspection certificate. However, the SÚKL checks whether the service and mandatory Safety and Technical Inspections (BTK) are performed by a person who is not only registered in the Register of Medical Devices (RZPRO) but also certified directly by the manufacturer for that specific device model. Using a "universal" service technician who is not authorised by the manufacturer is an administrative offence.

Operational and Documentation Failings

3. Advertising of Medicinal Products: Million-Crown Fines for a Single Word

The area of advertising regulation is a priority for the SÚKL because it directly affects public health, and fines here reach millions of crowns. It is crucial to distinguish between a medicine and a food supplement. The SÚKL primarily supervises advertising for human medicinal products. Advertising for food supplements is mainly handled by the Czech Agriculture and Food Inspection Authority (SZPI).

However, the greatest risk lies not in a typo, but in a strategic error. If your marketing department promotes a food supplement but uses "medicinal claims" (e.g., "cures inflammation," "eliminates pain"), the SÚKL can reclassify the entire product. In the regulator's eyes, your food supplement becomes an unregistered medicinal product.

This moves you from the relatively mild regulation of the SZPI to the strict jurisdiction of the SÚKL, and you face a fine of up to CZK 2,000,000 for promoting an unregistered medicine.

Other common mistakes in medicine advertising include:

• Advertising a prescription-only medicine to the general public.

• Using a "fear appeal" (e.g., "if you don't use the medicine, your condition will worsen").

• Claiming that a medicine is 100% effective or has no side effects.

• Endorsements from scientists, doctors, or celebrities.

• Missing the mandatory warning: "Read the package leaflet carefully before use."

Advertising medicinal products is a minefield. At ARROWS, we review advertising campaigns daily and provide legal consultations that protect our clients from fines.

4. International Context: EMA, Parallel Imports, and Exports

The SÚKL is not an isolated body. It is part of the European network of medicines agencies and works closely with the European Medicines Agency (EMA). This concerns you if you are involved in the parallel import of medicines from the EU or, conversely, their export.

The operational decision to "sell surplus stock abroad" is not just a business transaction but a highly regulated legal act. The SÚKL and the Ministry of Health actively monitor and penalise the so-called re-export of medicines intended for the Czech market. The illegal export of medicines worth tens of millions of crowns is actively investigated.

Problems with medicines often cross borders. Thanks to our ARROWS International network, we handle cases with an international element on a daily basis. Do you need legal assistance with international distribution? Contact us at consultation@arws.cz.

Advertising and International Distribution

Life After the Inspection: The Report, Objections, and Administrative Proceedings

The inspection does not end with the physical departure of the inspectors – the legal process is often just beginning.

• Step 1: The Inspection Report
  The inspector will draw up an inspection report summarising all findings. They have 30 days from the last action to prepare it, or 60 days in complex cases. You have the right to familiarise yourself with its contents and receive a copy.

• Step 2: Objections – Your Key Defence
  If you disagree with the findings in the report, you must submit written and duly substantiated objections. A critical legal trap lurks here: the deadline.
  
  Older regulations (the State Inspection Act), which the SÚKL sometimes still cites in its templates, specified a 5-day deadline. However, common practice and the newer legislation (the Inspection Code) work with a 15-day deadline. Relying on an old template in the report and submitting objections on the sixth day could be fatal – the authority may reject them as being late.
  
  Filing objections is crucial. If you do not file objections, it is assumed that you agree with the findings in the report. The report then becomes the final and indisputable basis for administrative proceedings to impose a fine.

• Step 3: Administrative Proceedings
  If your objections are rejected, the SÚKL will initiate administrative proceedings against you to impose a sanction. This is a full-fledged legal dispute that can last for months and result in fines in the tens of millions of crowns.
  
  The inspection report is not just a formality – it is a key piece of evidence. Filing timely and legally sound objections is absolutely essential for your defence. Our lawyers are ready to analyse the report and represent you in the objection process and subsequent administrative proceedings. For an immediate solution, write to us at consultation@arws.cz.

Prevention is the Best Defence: How ARROWS Builds Your Compliance

Reactively dealing with a SÚKL inspection is always more expensive and stressful than quality prevention. Thanks to our long-term experience in managing a portfolio of over 150 joint-stock companies and 250 limited liability companies, we see risk patterns before they become a problem.

For our clients in the healthcare and pharmaceutical sectors, we provide comprehensive legal services that minimise the risk of fines:

• Audit and setup of a pharmacovigilance system (mandatory monitoring and reporting of adverse drug reactions).

• Preparation of complete "bulletproof" documentation (policies, job descriptions).

• Expert training for employees and management to teach them how to behave during an inspection.

• Regular compliance audits that simulate a SÚKL inspection.

We pride ourselves on speed and high quality. We also enjoy connecting our clients with each other when we see interesting business or investment opportunities. We would be happy to hear your business idea as well.

Administrative Proceedings and Strategic Prevention

Conclusion: Don't Leave a SÚKL Inspection to Chance

A SÚKL inspection is a serious matter, but it is predictable. It focuses on documentation, advertising, and operational processes. Each of these areas can be legally addressed and prepared for.

Whether SÚKL inspectors have already visited you and left a report full of objections, or you want to responsibly prepare for their potential arrival, we are here for you. Our lawyers have extensive experience with SÚKL processes. For a comprehensive legal solution tailored to your company, write to us at consultation@arws.cz and arrange a consultation.