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Key takeaways
An Inspection from SÚKL on the Horizon: What Does It Mean for You?
Inspections are primarily governed by two key pieces of legislation. The first is Act No. 378/2007 Coll., on Pharmaceuticals, which defines the obligations of everyone who handles medicinal products. The second is Act No. 255/2012 Coll., the Inspection Code, which sets out the procedural rules for the inspection itself – from its commencement to its conclusion. In addition, there are a number of implementing decrees, for example on good pharmacy practice or the prescribing of medicinal products.
The Prague-based lawyers at ARROWS navigate this complex legislative environment on a daily basis and understand its nuances, which is a key advantage for clients in the event of an inspection.
Practical experience shows that SÚKL inspections rarely focus on uncovering intentional and malicious misconduct. Much more often, they function as a stress test of your internal processes and the quality of your documentation.
The most common shortcomings are not criminal offences, but procedural failures: missing or inadequately prepared Standard Operating Procedures (SOPs), failure to keep records of expiry date checks, or missing records of storage temperatures. This is also confirmed by the direct experience of inspected facilities, where inspectors focused precisely on these areas.
This leads to a fundamental insight: the greatest risk for a healthcare facility is not being "guilty," but being "unprepared." An inspection is essentially an audit of your operational resilience and precision. This changes the perspective on the whole situation – from a threat, it becomes a manageable challenge, where the key to success is building a robust system before the inspectors arrive.
Lawyers from ARROWS can be present throughout the inspection, oversee compliance with correct procedures, and ensure the protection of your rights. Need legal assistance during an inspection? Contact our experts.
How to Prepare for an Inspection Before the Inspectors Knock on Your Door
Proactive and systematic preparation is the best defence. This is not a one-off task, but a continuous process of maintaining order in key areas. Inspectors focus primarily on documentation and physical storage, so it is essential to pay maximum attention to these areas.
Standard Operating Procedures (SOPs) are the absolute foundation. They are not a formality, but a legal requirement. They must describe in a detailed, clear, and unambiguous manner all processes related to medicinal products and medical devices in your facility – from ordering and storage to disposal. Inspectors will want to see them first.
In addition to SOPs, you must keep precise records and logs. The most important of these include:
Temperature records: Daily temperature records in refrigerators and warehouses where thermolabile medicines are stored. These must be taken with calibrated thermometers.
Expiry date checks: Regular records of checking the shelf life of all medicines and their disposal.
Disposal of medicines: Records of discarded medicines and a contract with an authorised company for the disposal of hazardous waste, which must include waste code 180109.
Addictive substances: Special, very strict records for narcotic and psychotropic substances, which must be stored in a lockable metal safe and a responsible person must be appointed.
Do you consider your internal guidelines to be sufficient? Our lawyers at ARROWS can prepare or revise a complete set of internal guidelines and SOPs for you that precisely meet SÚKL's requirements and minimise the risk of error.
A physical inspection of storage areas is an integral part of the inspection. Medicinal products must be stored under the conditions specified by the manufacturer (temperature, protection from light), neatly arranged, and separated from other materials. Expired, damaged, or otherwise unusable medicines must be physically separated and visibly marked for disposal.
For medical devices (MDs), it is necessary to have a list of them available, indicating their risk class, instructions for use in the Czech language, and, above all, proof of regular safety and technical inspections (STIs) and maintenance at intervals specified by the manufacturer. Neglecting the maintenance of MDs is a common and serious offence.
Not sure if you meet all the maintenance requirements for your equipment? A legal consultation with experts from ARROWS will help you identify and rectify any gaps before an inspection points them out.
The Most Common Offences and How to Prevent Them
Potential Problems | How ARROWS Helps (consultation@arws.cz) |
Missing or outdated Standard Operating Procedures (SOPs) Confusion in processes, inconsistent procedures, high risk of further errors. One of the most frequently fined findings. Fine of up to CZK 2,000,000. | Preparation and revision of internal guidelines and SOPs tailored to your facility, which are in compliance with current legislation. |
Insufficient records of storage temperature Spoilage of expensive medicines (vaccines, biological treatments), risk to patients. A critical defect. Fines, obligation to dispose of stock. | Legal consultation and setting up control mechanisms that ensure compliance with requirements and protect you from sanctions. |
Use of expired medicines or their improper disposal Direct threat to patient health, environmental risks. A critical defect. Fines in the hundreds of thousands to millions of crowns, damage to reputation. | Preparation of contractual documentation with entities authorised for waste disposal and setting up internal processes for managing expiry dates. |
Errors in the records and storage of addictive substances Risk of misuse, strict penalties. Fines under the Act on Addictive Substances, in extreme cases even criminal liability. | Expert training for staff and preparation of documentation for record-keeping that will protect you from the most serious penalties. |
Unmaintained medical devices (missing STIs) Threat to the safety of patients and staff, non-functional equipment. Fines, possible order to suspend the use of the MD. | Legal audit of contracts with suppliers and service organisations, ensuring compliance with the requirements of the Act on Medical Devices. |
Incomplete documentation for the purchase of medicines (missing invoices, delivery notes) Suspicion of illegal purchase or re-export of medicines. Fines in the millions of crowns, risk of prohibition of activity. | Review and setup of purchasing and record-keeping processes, preparation of documents that demonstrate transparency and compliance with the law. |
Shortcomings in advertising regulation (promotional items, leaflets) Violation of the Act on Regulation of Advertising. High fines, which can reach up to CZK 5,000,000. | Legal opinion on your marketing materials and internal training for management and doctors on the rules of advertising in healthcare. |
D-Day: How the Inspection Itself Proceeds and What Your Rights Are
Even with the best preparation, the day of the inspection is stressful. Knowing the process and your rights will help you remain calm and professional.
The inspection is usually announced in advance, but it can also be unannounced, especially if it is based on an external tip or complaint. In any case, at the start of the inspection, the inspectors must present their service ID and written authorisation for the inspection.
Your basic duty is to provide the inspectors with the necessary cooperation – that is, to create conditions for the inspection, allow them entry to all relevant premises, and submit the requested documents and information. Obstructing an inspection is a separate offence, for which high penalties are threatened.
At the same time, however, you have your inalienable rights. You have the right to have your legal representative present during the inspection. You also have the right to object to the inspector's bias if you have reasonable doubts about their impartiality, and at the end of the inspection, you have the right to be acquainted with the content of the report.
The presence of a lawyer is not a sign of hostility, but of professionalism. Lawyers from ARROWS can be present throughout the inspection, oversee compliance with correct procedures by the inspectors, ensure the protection of your rights, and help with an immediate response to findings, thereby preventing unnecessary misunderstandings.
Our Prague-based lawyers at ARROWS will help you correctly evaluate this situation legally and set a strategy for its conclusion. Write to us for an assessment of your case.
What if the Inspection Reveals Shortcomings? From the Report to Sanctions.
If the inspection finds any misconduct, a critical phase begins where correct and swift legal action can determine the amount of any potential penalty.
All findings of the inspection body are summarised in the Inspection Report. This document is absolutely crucial because it forms the basis for any further proceedings. What is written in it is considered the established state of facts.
You have the right to file written and duly substantiated objections against the findings stated in the report. However, the deadline for filing them is very short. If you miss it or do not file objections, the findings from the report are considered undisputed, and you can no longer defend yourself against them.
Filing objections is a highly specialised legal act. ARROWS will analyse the report for you, identify contentious points, and prepare precisely formulated objections that maximise your chance of success. Missing the deadline means that the findings become essentially final.
Our specialists will help you
In recent years, there has also been a massive tightening of penalties, especially for record-keeping errors, due to the fight against illegal re-exports of medicines. Sanctions can climb up to 20 million crowns, and there is also a risk of a prohibition of activity. In this atmosphere, even a minor, unintentional error in the records can be viewed with great suspicion.
If your objections are not upheld, SÚKL will initiate administrative proceedings to impose a sanction. An appeal against SÚKL's decision can be made to the Ministry of Health. However, this is a complex process in which it is generally no longer possible to submit new facts that were not part of the original file. Success at this stage depends on perfect legal argumentation.
Responding to Inspection Findings
Potential Problems | How ARROWS Helps (consultation@arws.cz) |
Passive acceptance of the inspection report without objections The findings become an indisputable fact. Loss of the opportunity to defend oneself. The subsequent administrative proceeding is then only about the amount of the penalty, not about guilt. | Immediate analysis of the report and preparation of strategic objections that challenge incorrect or inaccurate findings of the inspection body. |
Missing the short deadline for filing objections The definitive end of the possibility to dispute the findings in the report. The inspection is formally concluded and cannot be revisited. | Monitoring key deadlines and ensuring the timely submission of all necessary documents. We take over the procedural responsibility for you. |
Unprofessionally written objections Objections are dismissed as unfounded. Wasting the only chance to reverse negative findings at an early stage. | Preparation of legally and factually perfect objections supported by evidence and correct argumentation, which have a real chance of success. |
Non-communication or poor communication with SÚKL Escalation of the problem, perception of non-cooperation, which can be an aggravating circumstance when determining the amount of the fine. | Professional representation in all communication with the administrative authority. We ensure that communication is always factual, correct, and strategic. |
Waiting for the outcome of the administrative proceedings without an active defence Imposition of the maximum possible sanction. The administrative authority has no reason to be lenient if it does not see an active and professional defence. | Active representation in administrative proceedings, presenting evidence, negotiating, and striving to minimise the impacts and the amount of any sanction. |
When the Solution Crosses Borders: International Aspects and ARROWS International
The regulation of medicinal products is highly harmonised within the European Union. SÚKL works closely with the European Medicines Agency (EMA) and other national agencies, with a regular exchange of information. For international companies, this means that a problem identified in the Czech Republic can have an impact on the entire group abroad and vice versa.
For sophisticated clients, such as pharmaceutical companies or international clinic networks, flawless regulatory compliance is not just a defensive cost. It is a strategic investment in international reputation. A clean slate in one EU country builds trust throughout the network of European regulators. Investing in top-tier legal assistance thus becomes a tool for building a "compliance passport" that facilitates smoother operations across Europe.
Thanks to our ARROWS International network, built over ten years, we handle cases with an international element almost daily. Whether you are a Czech company expanding abroad or a foreign entity operating in the Czech Republic, we will provide you with comprehensive legal services that take into account all local and international aspects.
Moreover, we can connect our clients. Are you looking for a reliable partner in Poland or Germany? Thanks to the ARROWS International network, we can open doors for you.
Don't Wait for a Problem. ARROWS is Your Partner in Both Prevention and Resolution.
As this guide shows, a SÚKL inspection is a complex process with many pitfalls, where even a small mistake can have serious financial and reputational consequences. Proactive preparation and professional legal support are the best investment to avoid stress, crippling fines, and damage to your facility's good name.
Our team is ready to provide you with comprehensive support at every stage:
Preventive legal audits and preparation for inspections.
Preparation and revision of all documentation (SOPs, guidelines, contracts).
Expert training for employees and management with a certificate.
Legal representation during the inspection and in subsequent proceedings.
Preparation of objections, appeals, and legal opinions.
Handling cases with an international element through ARROWS International.
Has an inspection been announced at your facility, or do you want to be sure that you are 100% prepared for one? Don't delay. Contact us today and arrange a no-obligation consultation. The team of experts at ARROWS is ready to protect your business.
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 350,000,000. 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.