ARROWS helped the client pass the SÚKL inspection
ARROWS provided comprehensive legal support to the client already during the preparation phase for the SÚKL inspection. The consulting services included a detailed review of internal documentation, in particular standard operating procedures (SOPs), records relating to the storage of medicinal products, expiry date checks, the handling of addictive substances, and documentation on the maintenance of medical devices. The firm also conducted a legal audit of the company's compliance with the Medicines Act, inspection rules, and implementing regulations, and proposed specific measures to eliminate the identified risks even before the inspection itself began.
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During the inspection, ARROWS provided the client with ongoing legal assistance, supervised compliance with procedural rules by the inspection authority, and assisted with responses to specific questions and findings of the inspectors. After the audit was completed, the firm analyzed the audit report and prepared qualified objections to selected conclusions, thereby significantly contributing to reducing the risk of sanctions and successfully closing the entire matter. The result was that the audit was completed without any significant financial penalties, the client's operational continuity was maintained, and a functioning framework for future audits was established.
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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.