Medicinal Product Storage in Czechia: Authorisations, Inspections and Compliance

JUDr. Jakub Dohnal, Ph.D., LL.M.
JUDr. Jakub Dohnal, Ph.D., LL.M.
9.4.2026 | ARROWS law firm

If you handle medicinal products as a distributor, pharmacy, or healthcare provider, you must comply with strict legal requirements for their storage. Missing authorisation or a poorly configured system can cost you millions in fines imposed by SÚKL (the Czech State Institute for Drug Control). In this article, you will find out which permits you need, what inspections focus on, and how to set up processes that will stand up under Czech law.

In the image, we see a specialist discussing the topic of legal requirements for the storage of medicinal products.

Quick summary

  • Distributors need a distribution authorisation; pharmacies and doctors need authorisation to provide healthcare services; however, everyone must comply with Good Practice rules.
  • Unauthorised handling of medicinal products or serious breaches of storage conditions may result in fines of up to CZK 20 million.
  • SÚKL and other authorities check temperature records, expiry-date tracking, and waste handling.
  • Continuous temperature measurement (data loggers) and robust SOPs (standard operating procedures) are essential prevention against sanctions.

What is meant by the storage of medicinal products and what authorisation you need

Storing medicinal products is not just a matter of physical space in a fridge or on a shelf. From a legal perspective, the handling of medicinal products is a strictly regulated activity governed by the Act on Medicinal Products (Act No. 378/2007 Coll.) and implementing decrees. If you hold medicinal products, whether for sale or for administration to patients, you must have the relevant authorisation and comply with the prescribed conditions.

A common misconception arises here: not every entity needs a distribution authorisation, which is why it is necessary to distinguish between distribution and the provision of healthcare or pharmacy services.

Without the relevant authorisation to handle medicinal products, you face a fine of up to CZK 20 million, which makes these offences among the most severely sanctioned in Czech administrative law.

The attorneys at ARROWS advokátní kancelář regularly encounter the issue of correctly categorising activities and handle cases where entities are in fact carrying out distribution without authorisation.

Who needs which authorisation

The scope of your obligations depends on your role in the medicinal supply chain:

  • Medicinal product distributors: Entities that procure, store and supply medicinal products to other distributors, pharmacies or healthcare providers. These entities must hold a distribution authorisation issued by SÚKL and comply with Good Distribution Practice rules.
  • Pharmacies: They need authorisation to provide healthcare services (pharmaceutical care) issued by the regional authority. They follow the rules of Good Pharmacy Practice. If a pharmacy wished to supply medicinal products to other pharmacies or distributors, it would also have to obtain a distribution authorisation.
  • Healthcare providers: Hospitals and outpatient clinics do not need a distribution authorisation to purchase and store medicinal products intended for their own patients. However, they must be authorised to provide healthcare services and meet the technical and material requirements for equipment.

Liability in the supply chain

Responsibility for the quality of medicinal products (including maintaining the temperature chain) is carried throughout the chain. The distributor is responsible for the medicinal product until the moment it is handed over to the customer. Upon receipt, the customer is obliged to check for obvious defects and compliance with transport conditions.

In practice, this means that you must have not only a contract with your distributor, but also processes in place for receiving goods. The attorneys at ARROWS advokátní kancelář routinely help clients review contracts that clearly define the transfer of risk of damage to goods and liability for temperature deviations.

Obtaining a distribution authorisation for distributors

If your business falls within the definition of distribution, the authorisation process is highly formalised. In the proceedings, SÚKL assesses whether the applicant meets the requirements of the Act on Medicinal Products and SÚKL guidelines.

Key stages of the process
  • Obtaining a trade licence: The regulated trade “Manufacture and distribution of medicinal products”.
  • Preparing the premises and the system: At the time of inspection, the warehouse must be fully prepared, equipped and mapped (temperature mapping).
  • Submitting the application to SÚKL: The Institute has a statutory time limit to decide, during which it will carry out an on-site inspection.
Requirements for storage premises and equipment

The Act and SÚKL guidelines require that the premises ensure the preservation of the quality of medicinal products. You must ensure:

  • A validated temperature monitoring system: Devices that measure and record temperature at regular intervals.
  • A warehouse temperature map: Evidence that temperature is stable and within the required range in critical areas of the warehouse.
  • Security: Protection against unauthorised access, rodents and insects.
  • Calibration of measuring instruments: Thermometers and hygrometers must be calibrated regularly.
Documentation for the application

The application must be supported by extensive documentation, including:

  • Legal title to the premises: A lease agreement or an extract from the Czech Land Register.
  • Standard operating procedures (SOPs): A detailed description of processes (receipt, storage, dispatch, complaints, recalls).
  • Appointment of a qualified person: The distributor must appoint a qualified person responsible for distribution who meets the educational and other statutory requirements.

The attorneys at ARROWS advokátní kancelář assist clients with compiling this documentation and preparing for the on-site inspection, which minimises the risk of the application being rejected or the proceedings being suspended.

The control system and what the authorities look for during an inspection

Whether you are a distributor supervised by SÚKL, a pharmacy, or a medical practice, inspections always focus on compliance with the Act on Medicinal Products.

Most common deficiencies and fines

Authorities focus on areas where an error may endanger patients’ health:

  • Breaches of the temperature chain: Missing temperature records or failure to comply with storage conditions. Here, fines may reach hundreds of thousands to millions of Czech crowns.
  • Expired medicinal products: Medicinal products past their expiry date must be physically separated and marked as unusable.
  • Deficiencies in records of addictive substances: Errors in record books for narcotic and psychotropic substances (OPL) are punished strictly.
  • Missing SOPs: Staff do not follow written instructions, or the instructions are missing.
Temperature monitoring

It is not enough to have an alcohol thermometer in the fridge. You must demonstrate that the temperature was compliant continuously.

  • Continuous monitoring: For thermolabile medicinal products, the standard is a recording device (datalogger) that records data at short intervals.
  • Daily check: For medicinal products stored at room temperature, recording the min/max temperature once a day is usually sufficient, provided a temperature mapping has been carried out.
  • Deviations: You must have a written procedure for handling temperature deviations and a record of how the medicinal products were handled.

Protection of medicinal products against counterfeiting

Pharmacies and distributors are subject to obligations arising from European legislation. Each pack of a prescription-only medicinal product has a unique identifier (UI/2D code).

  • Verification: Pharmacies must verify and deactivate the code in the repositories system (NMVS) upon dispensing.
  • Distributors: They have specific verification obligations in defined cases.

If you handle narcotic and psychotropic substances, you are subject to Act No. 167/1998 Coll., on Addictive Substances in the Czech Republic.

  • Record book: You must keep ongoing records, which must be numbered, bound, and authorised.
  • Security: Substances must be stored in a safe or a lockable metal cabinet, separately from other medicinal products.

Disposal of unusable medicinal products

Medicinal products are hazardous waste. The waste producer is obliged to ensure their disposal through an authorised person.

  • Contract with a disposal provider: You must have a valid contract with a company authorised to handle hazardous waste.
  • Records: You must keep records of generated waste and retain documents proving handover for disposal.
Risk and solution table

Risk / Breach

Sanctions (under the Act on Medicinal Products / Addictive Substances)

How ARROWS helps (office@arws.cz)

Unauthorised distribution

Up to CZK 20,000,000

Legal analysis of the activity, obtaining permits, setting up contracts.

Breach of storage conditions

Up to CZK 5,000,000 (depending on severity and type of entity)

Audit of internal policies, setting up storage SOPs.

Errors in OPL records

Up to CZK 5,000,000 (or even criminal liability)

Review of record-book keeping, staff training.

Non-compliant waste disposal

Fines under the Waste Act (up to millions of CZK)

Contractual arrangements for disposal, process set-up.

 

Practical solutions and setting up a functional system

To avoid sanctions, it is necessary to move from improvisation to systematic quality management.

Investment in technology: Purchase calibrated dataloggers with an alarm. Systems that send an SMS or email when the temperature is exceeded will allow you to save stock in time and will demonstrate to inspectors that you have the situation under control.

Tailor-made standard operating procedures: Do not blindly use templates downloaded from the internet. SOPs must describe the reality of your operation, including who checks the temperature and what to do if damaged packaging is found. Attorneys from ARROWS, a Prague-based law firm prepare documentation for clients that is legally compliant and at the same time understandable for staff.

The role of the qualified person and the responsible manager: Ensure that the person responsible for medicinal products (for a distributor, the qualified person; in a pharmacy, the managing pharmacist; in a practice, the physician) truly understands their obligations. A formal appointment without real oversight is risky.

Regular internal audits: Do not wait for SÚKL (the Czech State Institute for Drug Control). Carry out your own audit or hire external specialists at least once a year. Check expiry dates, completeness of records, and the functionality of equipment.

Most common mistakes and how to avoid them

  • Confusing distribution and dispensing: Some physicians or pharmacies believe they can freely sell medicinal products to other businesses. This is generally illegal distribution unless they have a distribution authorisation. Consult any business model that goes beyond standard dispensing to a patient with attorneys.
  • Uncalibrated thermometers: Having a thermometer is not enough. If you do not have a calibration certificate (usually valid for 2 years), SÚKL will not accept the measured values. Implement a calibration plan and monitor deadlines.
  • “Paper” SOPs: Inspectors ask frontline employees about procedures. If an employee does not know what to do in the event of a fridge failure, the SOP is considered non-functional. The solution is regular and demonstrable staff training.

How to prepare for an inspection by SÚKL or the Regional Authority

Before the inspection

Keep your documentation up to date every day, including temperature and cleaning records. Backdating entries is a criminal offence (falsification of documentation) and experienced inspectors can easily detect it.

During the inspection

Provide full cooperation and designate a competent person to accompany the inspectors. Have inspection reports, calibration certificates and SOPs ready.

After the inspection

If the inspection identifies deficiencies, use the deadline for filing objections if the findings are disputable. If administrative offence proceedings are initiated, contact a Prague-based law firm immediately. ARROWS advokátní kancelář has experience representing clients in administrative proceedings, where it is often possible to reduce or overturn penalties based on procedural errors by the authority.

Conclusion

Medicinal product storage is a process governed by dozens of regulations under Czech law. The aim of regulation is patient safety, but for businesses it represents a significant administrative and procedural burden. SÚKL and other authorities carry out inspections rigorously, and penalties for non-compliance can be devastating.

The key to safe operations is prevention in the form of a functional monitoring system, high-quality contractual documentation and trained staff.

The attorneys at ARROWS advokátní kancelář are ready to help you set up compliance processes, obtain the necessary permits and defend you in the event of inspections. If you are not sure whether your processes are set up correctly, feel free to contact us at office@arws.cz.

FAQ – Most common legal questions

1. Does a general practitioner’s clinic need a distribution authorisation to store vaccines?

No, it does not need a distribution authorisation if it uses the vaccines only for its own patients in the course of providing healthcare services. However, it must have an approved operating rules and comply with storage conditions under the Summary of Product Characteristics and Decree No. 92/2012 Coll. of the Czech Republic.

2. What is the temperature tolerance for storage?

Tolerance depends on the stability data of the specific medicinal product. Generally, the limits are 2–8 °C and 15–25 °C. Any short-term deviation must be assessed based on data from the manufacturer. If no record is available, a quality breach is presumed.

3. Can I sell medicines approaching expiry to another company?

Only if you have a distribution authorisation. A standard pharmacy or clinic cannot sell medicines to another company (except for specific, limited exceptions for pharmacies in cases of unavailability of medicinal products).

4. What should I do if the datalogger shows that the temperature rose above 8 °C overnight?

Immediately place the medicinal products in quarantine. Contact the manufacturer to ask about stability at the given temperature and for the duration of the deviation. Make a written record of this procedure. If the manufacturer does not confirm safety, the medicinal products must be disposed of.

5. Do I need special software for temperature monitoring?

The law does not prescribe specific software, but the system must meet data integrity requirements. An Excel spreadsheet where you manually transcribe values is risky and unsuitable for continuous monitoring of refrigerators.

Notice: The information contained in this article is of a general informational nature only and is intended for basic orientation in the matter based on the legal situation as of 2026. It does not replace specific legal advice. To address your specific situation, contact ARROWS advokátní kancelář (office@arws.cz).

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