Medicinal product distribution in the Czech Republic: Licensing and compliance

JUDr. Jakub Dohnal, Ph.D., LL.M.
JUDr. Jakub Dohnal, Ph.D., LL.M.
26.5.2026 | ARROWS law firm

Distribution of medicinal products in the Czech Republic is a licensed activity subject to strict regulation and high fines for mistakes. This article provides an overview of how to obtain authorisation to distribute medicinal products, what the practical operational requirements are, and why it is essential to distinguish between a medicinal product and a food supplement in manufacturing, marketing, and distribution.

In the image, we see a specialist consulting on a medicinal products distribution authorisation.

Key takeaways

The distribution of medicinal products in the Czech Republic is a highly regulated activity that requires a licence from the State Institute for Drug Control (SÚKL), compliance with Good Distribution Practice rules, and a robust risk management system. At the same time, in practice the boundary between medicinal products and food supplements is increasingly being addressed, because supplements fall under food law, have a different approval regime, but are often manufactured, packaged, and distributed through channels similar to those used for medicinal products. 

For entrepreneurs and investors, it is therefore not only the acquisition of the distribution licence itself that matters, but the comprehensive set-up of the entire commercial, operational, and regulatory framework, including correct product classification, contractual allocation of liability, and readiness for inspections by SÚKL, food supervision authorities, and other regulators.

In the following summary you will find three key conclusions that are typically decisive for business owners, investors, and management.

The first point is that the distribution of medicinal products in the Czech Republic is possible only on the basis of a SÚKL licence; without it, any distribution is unlawful, and breaches may result in fines of up to CZK 20 million and the effective destruction of the business.

The second point is that a medicinal products distributor must demonstrably meet the requirements of Good Distribution Practice (GDP/SDP), in particular in the areas of storage, transport, documentation, pharmacovigilance, and reporting, and inspections focus not only on the status at the time the licence is granted but also on ongoing compliance with the standards. For more detail on typical contractual clauses and practical compliance steps in the supply chain, see our guidance on Contract for Work in 2026: Key Clauses, Payment Risks and Dispute Prevention.

The third key point is that food supplements are, from a legal perspective, “only” foods; they are subject to different regulations and a notification regime with the Ministry of Health, but incorrect presentation or composition may lead to reclassification as a medicinal product, with retroactive consequences, sales bans, and sanctions. Our text How to tell whether your product falls under SÚKL, SZPI or ČOI also addresses the practical impacts of reclassification and market surveillance in more detail.

In practice, this means that the strategic decision whether to enter the segment of distributing medicinal products, food supplements, or both has a fundamental impact on capital requirements, compliance, contractual documentation, and reputational risks—and it is worth preparing it with attorneys from a specialised Prague-based law firm so that the entire model withstands scrutiny by SÚKL, food inspections, and business partners. Where the project includes warehousing, cold-chain logistics, or fit-out of regulated premises, legal support from Development & Construction Law can help align build-out documentation with operational compliance requirements.

Distribution of medicinal products under Czech law: The basic framework and the difference compared to food supplements

The basic starting point for the entire issue is the legal definition of a medicinal product.  Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Certain Related Acts (the Pharmaceuticals Act), provides that a medicinal product is a substance or combination of substances presented as having therapeutic or preventive properties in humans, or a substance that may be used to restore, correct, or modify physiological functions through a pharmacological, immunological, or metabolic effect, or to make a medical diagnosis.

This definition is relatively broad, and therefore in practice borderline situations often arise where a manufacturer or distributor presents a product as a food supplement, but supervisory authorities may assess it as a medicinal product due to the content of active substances, the form, or marketing claims. A practical overview of how marketing statements can trigger regulatory issues is also covered in Health Claims vs Medicinal Advertising: Compliance Risks for Supplements & Cosmetics. When setting up internal processes and contractual liability in a regulated healthcare environment, it may also be useful to draw on our experience in the area of healthcare law.

By contrast, a food supplement is expressly defined under Czech law in Act No. 110/1997 Coll., on Foodstuffs and Tobacco Products and on Amendments and Supplements to Certain Related Acts, as a food whose purpose is to supplement the normal diet and which is a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect, supplied in measured doses, for example in the form of tablets, capsules, or drops.

Food supplements therefore fall under the Foodstuffs and Tobacco Products Act, not the Pharmaceuticals Act, and they are subject both to the general requirements of food law and to the specific Decree No. 58/2018 Coll., on food supplements and the composition of foods, which, among other things, regulates mandatory labelling and the conditions for the use of certain plants and other substances. 

The difference in legal classification has fundamental impacts not only on the requirements for placing products on the market, but also on subsequent distribution and marketing. The article What you risk when you claim “medicinal effects” without a medicinal product registration also addresses, specifically, the risks of presenting “medicinal effects” and possible sanctions. The differences are also strongly reflected in the approval process prior to placing products on the market. 

Medicinal products undergo a marketing authorisation procedure in which SÚKL assesses their quality, safety, and efficacy for specific indications; this includes clinical trials meeting strict criteria under special legal regulations.

Without a final decision granting marketing authorisation, a medicinal product cannot be placed on the market in the Czech Republic, not even on a very limited basis, except for specific treatment programmes and special regimes, which are themselves regulated in detail. In practice, these requirements are also reflected in the set-up of supplier-customer relationships and liability allocation, where legal support in the area of contracts and negotiations can help. 

By contrast, placing a food supplement on the market in the Czech Republic is subject to a notification procedure with the Ministry of Health, within which the product’s health safety is assessed; however, this is not a full marketing authorisation of efficacy in the sense applicable to medicinal products.

A key difference also lies in what claims may be used on the product and in marketing. Food supplements must not declare properties of preventing, treating, or curing diseases, nor refer to such properties; otherwise, there is a risk they will be considered an unregistered medicinal product. 

For foods, including food supplements, the regime of health and nutrition claims also applies; such claims may be used only if they have been authorised at EU level on the basis of a scientific assessment by the European Food Safety Authority (EFSA) under Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods.

By contrast, for medicinal products, marketing and informational communications must be based on the Summary of Product Characteristics (SmPC), which is approved as part of the marketing authorisation, and advertising of medicinal products is regulated by Act No. 40/1995 Coll., on the Regulation of Advertising.

For entrepreneurs, it is crucial to understand that the boundary between a food supplement and a medicinal product is not determined only by the product’s form (tablet vs capsule) or its placement on a pharmacy shelf, but by a combination of composition, dosage, and, above all, the way it is presented to customers. 

In practice, we often see marketing departments preparing communications essentially as if for a medicinal product, while the product is formally classified as a food supplement—this significantly increases the risk of regulatory intervention and reclassification, with a retroactive distribution ban, an obligation to withdraw the product from the market, and potentially fines. 

Attorneys from a specialised Prague-based law firm therefore routinely recommend that clients address, already at the product development stage, not only the composition and statutory limits, but also the intended communication concept, so that the entire strategy is consistent and sustainable.

What “distribution of medicinal products” is and when you need an authorisation from SÚKL

The Czech Act on Medicinal Products defines the distribution of medicinal products very broadly as all activities consisting in procuring, storing, supplying medicinal products, including supplies within the EU and exports to third countries, and related commercial transfers, regardless of whether the activity is carried out for consideration or free of charge. 

Distribution therefore typically includes wholesale purchases from manufacturers or other distributors, storage in a distribution warehouse, supplies to pharmacies and healthcare facilities, as well as logistics associated with exporting medicinal products abroad or specific models of direct distribution between a manufacturer and selected pharmacies.

However, it does not include dispensing to patients, which is reserved for pharmacies and is subject to a different regime, nor the ordinary sale of foods, including food supplements.

A key practical point is that a decision granting an authorisation to distribute medicinal products issued by SÚKL is a necessary condition without which distribution of medicinal products in the Czech Republic cannot be carried out at all. The authorisation is mandatory for both Czech and foreign entities that wish to distribute medicinal products from the territory of the Czech Republic, and it applies to both human medicinal products and veterinary medicinal products (for the latter, the competent authority is the Institute for State Control of Veterinary Biologicals and Medicines).

Without a valid authorisation, it is not legal to purchase medicinal products from manufacturers and other distributors or to supply them to pharmacies or hospitals, even if only limited volumes are involved or supplies are provided free of charge.

From a sanctions perspective, it should be borne in mind that unauthorised distribution of medicinal products constitutes a serious breach of the Czech Act on Medicinal Products, for which fines of up to CZK 20 million may be imposed on legal entities and self-employed individuals.

In addition to a financial penalty, SÚKL may also impose measures consisting in the suspension or revocation of the distribution authorisation, which in practice means stopping the distributor’s operations and often also the devaluation of the entire investment in warehousing and logistics capacities. 

For certain offences, the law also provides for the liability of specific individuals (for example, the distributor’s qualified person), and the penalty may have a significant personal impact on management, including a ban on activity or personal fines of up to CZK 500,000.

By contrast, distribution of food supplements is significantly less demanding from a licensing perspective. Since food supplements are foods, entrepreneurs only need to meet the requirements of food law, including registration as a food business operator, implementation of an HACCP system, and fulfilment of the notification obligation towards the State Agricultural and Food Inspection Authority (SZPI) or the State Veterinary Administration (SVS), as relevant. 

An authorisation from SÚKL to distribute food supplements is not required; however, when distributing them through the pharmacy channel, it is necessary to comply with the internal rules of business partners and any specific quality and safety requirements. 

It follows that an entrepreneur who wants to operate in the healthcare products market must think very carefully about which segment and what level of regulation they are willing to accept.

Related questions on the basic distinction between medicinal products and food supplements

  1. Can I state on a food supplement that it “treats” a specific disease?
    The answer is unequivocally no: food supplements must not declare therapeutic, preventive, or diagnostic effects, nor refer to them; otherwise, there is a risk they will be assessed as an unregistered medicinal product, resulting in a distribution ban and potential fines.
  2. Does the product form determine its legal classification (e.g., tablet, capsule)?
    The form alone is not decisive; what matters is the combination of composition, dosage, and presentation to the customer, with regulators assessing the product comprehensively. A substance in a low concentration may be a food supplement, but at a high dose and with a therapeutic claim it will typically be a medicinal product.
  3. Is it possible to “convert” a food supplement into a medicinal product if it succeeds on the market?
    This route is possible, but it requires a demanding marketing authorisation procedure, clinical data, and an entirely different compliance framework; it is therefore advisable to plan this step strategically with pharmaceutical law experts, for example attorneys from a specialised Prague-based law firm.

How to obtain an authorisation to distribute medicinal products

The process of obtaining an authorisation to distribute medicinal products in the Czech Republic is governed primarily by the Czech Act on Medicinal Products and the implementing decree No. 229/2008 Coll. on the manufacture and distribution of medicinal products. These regulations transpose the requirements of European Union law, in particular Directive 2001/83/EC on the Community code relating to medicinal products for human use, and supplement them with national rules on certain procedural details and supervisory mechanisms.

The area of distribution is regulated in the Czech Act on Medicinal Products mainly in provisions on distributors’ obligations, including the obligation to comply with Good Distribution Practice, report distribution data, and ensure a system for recalling medicinal products from circulation.

The State Institute for Drug Control (SÚKL) is the administrative authority that decides on authorisations for the distribution of human medicinal products, monitors compliance with the conditions, and imposes sanctions in the event of breaches. 

Before commencing distribution activities, it is necessary to apply to SÚKL in advance for the issuance of an authorisation, and without this authorisation distribution cannot be carried out legally. SÚKL also issues guidance and methodologies that specify practical requirements for distributors and often go beyond the wording of the law itself, for example in the area of temperature monitoring during the storage and transport of medicinal products. For entrepreneurs, it is important to follow not only statutory regulations but also these secondary guidance documents, because in practice they are decisive during inspections.

In recent years, the legal regulation of medicinal product distribution has been changing continuously, in particular in response to issues with re-exports, shortages of certain medicines, and EU requirements to strengthen pharmacovigilance. Amendments to the Act on Medicinal Products, for example, have tightened distributors’ reporting obligations towards SÚKL (the Czech State Institute for Drug Control), especially in connection with the distribution of medicinal products abroad and for products with restricted availability status.

The changes also affect the level of fines for failing to keep or retain records, which for healthcare providers (including pharmacies) may reach up to CZK 20 million. From the perspective of strategic company management, it is therefore necessary to continuously monitor legislative developments and not treat a once-established compliance system as final.

Prerequisites before submitting an application: Business and operational readiness

Before an entrepreneur even applies for a licence to distribute medicinal products, they must have the basic prerequisites for carrying out the activity in place. First and foremost, this means authorisation to conduct business in the relevant field, typically in the form of a trade licence for wholesale activities; however, the trade licence itself is not sufficient for medicinal product distribution and is only of a general nature.

Obtaining a company identification number (IČO) is therefore only the first step, and medicinal product distribution cannot be commenced solely on the basis of a trade licence, as this would constitute unlawful activity contrary to the Act on Medicinal Products.

Equally essential is the readiness of warehouse and operating premises in line with Good Distribution Practice requirements. The distributor must ensure that the premises, installations and equipment used for the storage and distribution of medicinal products correspond to the type and volume of products distributed, including ensuring temperature control, protection against contamination, and security against theft and unauthorised access. 

In practice, this means investments in storage technology, temperature monitoring, security systems and IT infrastructure for record-keeping and batch traceability. During an inspection, SÚKL assesses not only formal descriptions but also the actual technical condition and operating procedures.

An important staffing prerequisite is ensuring a qualified person for the distributor, who is responsible for compliance with Good Distribution Practice rules and for ensuring that distribution activities are carried out in accordance with the law and internal regulations. The requirements for the qualified person are based on the European framework and require appropriate professional education and experience in pharmacy or related disciplines, including at least two years of experience in medicinal product distribution. 

From a risk perspective, it is significant that the qualified person bears independent responsibility for serious breaches of their duties and may be fined up to CZK 500,000, while the distributor as a legal entity is responsible for ensuring the services of a qualified person and that the required professional prerequisites are met.

Submitting the application for a licence and its requirements

The application for a licence to distribute medicinal products is submitted to SÚKL on the prescribed form set out in guideline DIS‑8 and based on the requirements defined in the Decree on the Manufacture and Distribution of Medicinal Products. The form is usually available electronically, and the application may be submitted via a data box, by post, or in person to the designated SÚKL address.

In addition to the completed form itself, the application must include a number of mandatory annexes, such as documentation on the storage premises (floor plans, technical reports), proof of the right to use the premises (a lease agreement or title deed), internal policies and standard operating procedures (SOPs), and documents evidencing the qualifications of key persons.

The submission must also include proof of payment of the administrative fee, which is paid by bank transfer based on a variable symbol generated using SÚKL’s interactive form; payment is evidenced by a printed form stating the payment date. 

As of 2024, administrative fees can no longer be paid using revenue stamps. The administrative fee is relatively marginal in terms of the overall investments into a distribution business; however, errors in its payment or documentation may lead to unnecessary delays in the proceedings, because if the application is incomplete, SÚKL will invite the applicant to remedy the deficiencies and only after the defects are rectified will the time limit for the decision start running.

In well-prepared projects, it therefore pays to pay attention to these “procedural details” as well, which in aggregate may determine whether you obtain the licence within months or only after a longer period. After the application is submitted, SÚKL will confirm its receipt and check the completeness of the supporting documents. 

In the event of deficiencies, it will invite the applicant in writing to supplement them, which in practice means that if the documentation is not prepared carefully, the process may be extended by several weeks to months. 

The statutory time limit for processing a complete application is 90 days; however, in practice it should be expected that the total time from the first submission until the decision becomes final may be around three to six months, depending on the applicant’s preparedness and the workload of inspectors. 

Attorneys from a specialised Prague-based law firm help clients in such cases already at the project planning stage so that the documentation and processes meet SÚKL’s expectations and the proceedings run without unnecessary delays.

On-site inspection and issuance of the decision

Before issuing a licence to distribute medicinal products, SÚKL will carry out an on-site inspection in which inspectors verify whether the applicant in practice meets the statutory conditions, including Good Distribution Practice requirements. The inspection typically focuses on the physical condition of warehouse and operating premises, the set-up of temperature regimes and monitoring, security against unauthorised access, documentation including SOPs, record-keeping documentation on the movement of medicinal products, and the readiness of systems for withdrawing medicinal products from the market (recall).

Inspectors also assess the arrangements for the qualified person, their actual involvement in managing the distribution system, and documentation of employee training.

If the inspection demonstrates compliance with the requirements, SÚKL will issue a decision granting the licence to distribute medicinal products, in which it may also set specific conditions, for example limitations to certain types of medicinal products or requirements to supplement certain procedural measures. 

Once the decision becomes final, the distributor is entered into the national register and the European EudraGMDP database, and is assigned a distributor code used in communication with business partners and supervisory authorities. Only from this moment is it possible to legally commence the purchase and sale of medicinal products; any distribution activity before this point is highly risky.

If the inspection reveals serious deficiencies, SÚKL may refuse to issue the licence or make it conditional on a repeat inspection after the identified shortcomings have been remedied. Such a scenario means not only a delay in the time to start the business, but also additional costs for adjustments to premises, systems and documentation. 

In the experience of attorneys from a specialised Prague-based law firm, some problems arise from underestimating details—for example, incompletely described and impractically set SOPs, insufficiently documented warehouse temperature mapping, or unclear allocation of responsibilities between the distributor and an external logistics partner. This is precisely why it is advantageous to have an independent “pre-audit” prepared before the inspection, simulating SÚKL inspectors’ approach.

Related questions regarding the licensing process

  1. Must a distributor have its own warehouses, or can it use an external logistics center?
    From a legal perspective, it is possible to use third-party logistics (3PL) services; however, the distributor bears full responsibility for compliance with Good Distribution Practice requirements and must therefore have clearly defined contractual obligations, access to records, and control mechanisms agreed with the logistics partner.
  2. Is it possible to start distributing medicinal products before the permit is formally issued?
    Such a procedure is contrary to the Czech Act on Medicinal Products and exposes the company to the risk of sanctions and jeopardising the permitting process itself; distribution may only begin once the SÚKL decision has become final and effective.
  3. Is it necessary to apply for a new permit when expanding premises or changing the distribution model?
    In these cases, the law requires that you apply to SÚKL in advance for an amendment to the issued permit, and failure to comply may be sanctioned. In such situations, it is worth consulting the planned changes with attorneys from a specialised Prague-based law firm, who can help set the timeline and scope of the change procedure so that it does not endanger day-to-day operations.

Good Distribution Practice (GDP/SDP) and operational requirements

Good Distribution Practice (SDP, in English Good Distribution Practice – GDP) is a set of rules and guidelines aimed at ensuring that medicinal products are protected during distribution against deterioration, counterfeiting and other risks, and that they reach patients with the declared quality, safety and efficacy. 

GDP builds on Good Manufacturing Practice and creates a continuous quality management system from the manufacturer to the healthcare provider or pharmacy, and in some cases even further, for example when supplying research facilities or specific treatment programmes.

From a legal perspective, it is a binding standard that distributors are required to comply with, and breaches may lead to sanctions, including restriction or withdrawal of the permit.

GDP primarily covers quality control, storage, transport, documentation and traceability, staff training, handling complaints and withdrawing medicinal products from the market, and preventing falsification of medicinal products. In practice, this is reflected in detailed standard operating procedures (SOPs), the technical equipment of warehouses and means of transport, and IT systems that make it possible to track the movement of individual batches and verify their authenticity. 

For company management, this means that the distribution of medicinal products is not merely a matter of logistics and sales, but a fully-fledged area of risk management requiring the active involvement of management, the compliance department and the responsible person.

Storage, temperature and technical requirements

For the storage of medicinal products, the decree on the manufacture and distribution of medicinal products and related SÚKL guidelines set specific requirements for premises, equipment and monitoring of conditions. Medicinal products must be stored under the conditions stated in the marketing authorisation decision and in the package leaflet, in particular as regards temperature, humidity, protection from light and contamination.

Storage temperatures are usually divided into storage at room temperature (15–25 °C), cool (8–15 °C), refrigerated (2–8 °C) and in a freezer (−15 °C and below), while for thermolabile medicinal products continuous temperature monitoring using appropriate devices is required.

SÚKL Guideline DIS‑15 sets out the basic requirements for ensuring, controlling and documenting temperature during the storage and transport of medicinal products, including the use of calibrated thermometers, temperature mapping and alarm systems. For refrigeration and freezing equipment, it is necessary to regularly verify the temperature distribution in the space by so-called temperature mapping, especially after reconstructions or interventions in cooling units that may affect the temperature profile.

Temperature records must be retained and, in the case of electronic form, also backed up; during SÚKL inspections, inspectors focus not only on the existence of records, but also on how any deviations are handled and on the assessment of the impact on the quality of medicinal products.

In a hospital environment, where medicinal products are further stored on wards, similar rules apply, including regular temperature monitoring, appropriate arrangement of storage areas, protection against humidity and locking systems for medicine cabinets to prevent unauthorised access. 

For distributors, it is essential that their responsibility ends only upon handover of the medicinal product to an authorised entity (a pharmacy, a healthcare provider, another distributor) and that they must be able to demonstrate that, up to that point, storage and transport conditions complied with the marketing authorisation requirements and GDP. Any deterioration of goods due to incorrect temperature may have significant financial impacts, including the need to dispose of stock and claims by manufacturers or customers.

Documentation, traceability and reporting

GDP places great emphasis on documentation and traceability, which is one of the pillars of the fight against falsified medicines and a tool to ensure the ability to quickly withdraw a product from the market. The distributor must keep, to a sufficient extent, records of all movements of medicinal products for at least five years, including details of suppliers, customers, quantities, batch numbers and the delivery date.

Each delivery of a medicinal product must be accompanied by documentation that enables the path of the medicine to be traced, including identification of the customer and supplier; where the customer is both a pharmacy and a distributor, the documentation must distinguish whether it received the delivery in the role of a pharmacy or a distributor, which is relevant for the subsequent distribution chain and liability.

In addition to internal records, the Czech Act on Medicinal Products imposes on distributors an obligation to regularly provide SÚKL with complete and accurate data on supplies of human medicinal products via electronic reporting under the implementing decree. This mainly concerns data on the volume of distributed medicines, the structure of customers and other parameters that SÚKL uses to monitor the availability of medicines on the market and to identify potential issues with re-exports. 

Furthermore, the distributor is obliged to notify in advance electronically its intention to distribute abroad a medicinal product that is included on the list of products with limited availability, and to provide data on the quantity, destination country and planned distribution date.

Breaches of reporting obligations are classified by law as an administrative offence and may lead to fines, while an amendment to the Act on Medicinal Products has strengthened the importance of these obligations in connection with protecting the availability of medicines for patients in the Czech Republic. 

In practice, it turns out that the configuration of internal IT systems and processes for timely and correct reporting is often a weak point, especially for rapidly growing distributors or in situations where a company is migrating to a new ERP system. 

Attorneys from a specialised Prague-based law firm therefore recommend linking legal requirements with IT and process design from the very beginning of the project to avoid additional costly adjustments and the risk of sanctions.

Medicinal product recall system, complaints and counterfeiting

Part of the distributor’s obligations is to ensure an effective system for withdrawing medicinal products from circulation (recall) in the event of quality defects, safety signals or suspicion of counterfeits. The distributor must have procedures in place for rapid identification of affected batches, informing customers, organising the logistics return of products, and communication with the marketing authorisation holder as well as with SÚKL.

In situations where patient safety is at risk, the speed and reliability of these systems play a crucial role, and during inspections SÚKL assesses not only formalised internal policies but also real-life testing and experience with actual or mock recall actions.

The issue of counterfeit medicines has a global dimension and affects even lawful distribution channels, although data show that in the Czech Republic counterfeits have so far appeared on the legal market rather exceptionally. Nevertheless, distribution is one of the critical links where counterfeits may infiltrate, especially if the distributor does not sufficiently verify its suppliers or customers and does not have effective processes in place to check the safety features on the outer packaging of medicinal products under Commission Delegated Regulation (EU) 2016/161, supplementing Directive 2001/83/EC. 

A distributor is obliged to verify that the medicinal products it receives are not counterfeit, including by checking these safety features, and at the same time must source medicines only from manufacturers or other authorised distributors.

A properly set up system for handling complaints and communicating with manufacturers and pharmacies is important not only from a compliance perspective, but also in terms of business relationships and the distributor’s reputation. An insufficient or slow response to complaints and suspicions of quality defects may lead to damage to relationships with key partners and to the redirection of business flows to other distributors. 

A specialised Prague-based law firm helps clients in these situations not only with setting internal policies, but also with negotiating contractual terms with manufacturers and customers so that responsibilities and processes for recall actions and complaints are clearly allocated.

Related questions on operational requirements and GDP

  1. Must a distributor always have continuous temperature monitoring for thermolabile medicines, or are manual records sufficient?
    For medicines requiring storage in a refrigerator or freezer, continuous electronic monitoring with alarms and regular calibrations is expected; manual records once a day would not be considered sufficient.
  2. How long must documentation on distribution activities be retained?
    The law requires records of distribution activities to be retained for five years, but in some cases a longer period is recommended, especially in view of potential complaints or court disputes.
  3. How can GDP requirements be aligned with the use of external carriers?
    Here too, the distributor bears full responsibility and must have appropriate contracts, training and control mechanisms agreed with carriers; attorneys from a specialised Prague-based law firm commonly help clients prepare transport agreements so that they comply with GDP requirements and minimise risks when transporting sensitive medicinal products.
Legal regime for food supplements and notification

As already stated, food supplements are classified as foods under Czech law and are subject to the Food and Tobacco Products Act and related European regulations. 

Specific national regulation is contained in Decree No. 58/2018 Coll., on food supplements and the composition of foods, which transposes Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements, and regulates in more detail the composition of supplements, mandatory labelling and the use of certain plants and substances.

In the Czech Republic, food supplements are assessed and approved by the Ministry of Health, which in the notification procedure verifies the product’s health safety, in particular in terms of composition, purity and the recommended daily dose. To place a food supplement on the market, it is necessary to send the Ministry of Health the text of the Czech label, and the product is subsequently entered in the register of decisions of the Chief Public Health Officer. 

From the perspective of the manufacturer and distributor, responsibility for meeting the requirements of food law lies fully with the food business operator, which must ensure that the product contains only approved bioavailable forms of vitamins and minerals, health-beneficial (not risky) plant extracts, and that it does not contain contaminants of chemical or microbiological origin. The safety assessment is carried out by the National Institute of Public Health (Státní zdravotní ústav) on the basis of the submitted documentation and laboratory analyses.

The Decree on food supplements contains annexes with a list of plants and other substances that may or may not be used in the manufacture of supplements and also sets conditions for their use; however, these lists are not exhaustive, and when developing new products it is often necessary to combine various food-law regulations. 

As of 1 January 2026, an amendment to this decree (Decree No. 200/2023 Coll., specifically the part concerning Annex No. 5) will take effect, which, among other things, updates the lists of permitted and prohibited substances and уточňuje some labelling requirements, which is significant for manufacturers and distributors in terms of planning their product portfolio. A specialised Prague-based law firm therefore recommends that clients already take the future wording of the decree into account when designing formulations and labels to avoid the need for additional changes later.

Health and nutrition claims and marketing of food supplements

Food supplements are subject to the regime of health and nutrition claims under Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods, which aims to ensure that claims stated on labels or in advertising are truthful, scientifically substantiated and understandable to the average consumer.

Health claims link a food or its component to a specific health benefit, for example “vitamin C contributes to the normal function of the immune system”, and may be used only if they have been authorised and included in the EU list of authorised claims. Nutrition claims, such as “source of fibre” or “low fat”, relate to the composition of the food and are also regulated.

Food supplements must not declare that they treat or prevent diseases; they must not contain claims that could lead consumers to believe that the product replaces medical care or treatment, or that it is comparable to a medicinal product. 

In practice, however, we often see advertisements that balance on the edge of permitted claims and use wording that is formally compliant with the law, but in combination with visuals and context creates the impression of a therapeutic effect.

From the regulator’s perspective, the decisive factor is the overall impression of the communication, not merely the text of labels or advertising in isolation.

Regulation of advertising of food supplements falls primarily under the general rules on advertising of foods and misleading commercial practices; at the same time, it must not breach the rules of Act No. 40/1995 Coll., on Advertising Regulation, in the part concerning references to public authorities or the misuse of the authority of healthcare professionals. 

A key difference compared to medicines is that advertising of food supplements may be targeted directly at consumers without restriction, whereas for prescription-only medicines advertising is intended only for healthcare professionals and is prohibited for ordinary consumers. This asymmetry creates significant marketing space for food supplements, but at the same time increases the risk of regulatory intervention if product communications cross the line between a food and a medicinal product.

Borderline situations and the risk of reclassification as a medicinal product

In business practice, a very common problem is a borderline situation where a product formally presented as a food supplement contains substances or uses marketing claims that are close to medicines. 

The Act on Medicines and related case law are based on the principle that if a product meets the definition of a medicinal product, it is subject to the medicines regime, regardless of how the manufacturer or distributor has labelled it.

The regulator may therefore intervene—and in some cases must intervene—and reclassify the product as a medicinal product, which has dramatic consequences for the possibility of its further distribution.

Typically, the issue arises with products containing high doses of vitamins, minerals, or herbal extracts for which studies indicate therapeutic effects, and which are marketed as solutions to specific health problems. If a product claims, for example, “treatment of joint pain” or “normalisation of blood pressure” and contains high doses of pharmacologically active substances, it is likely to be assessed by supervisory authorities as a medicinal product.

The consequences may include a ban on placing the product on the market as a food supplement, an obligation to withdraw the product from distribution, destruction of stock, and, in extreme cases, the initiation of administrative proceedings for the illegal placing of a medicinal product on the market without registration, with fines of up to CZK 20 million.

Another risk factor is non-compliance with statutory requirements for the composition of food supplements, especially where the product contains substances listed in the annexes to the implementing decree as prohibited or restricted, or substances whose use in foods is not generally permitted. 

In such a case, the food supervisory authority may order the product to be withdrawn from the market, impose a fine, and potentially inform other authorities as well, including SÚKL (the Czech State Institute for Drug Control), if it considers that the product meets the characteristics of a medicinal product. Here too, the food business operator bears responsibility for the product’s composition and safety.

Questions about the differences between food supplements and medicinal products

  1. From a regulatory perspective, is it more advantageous to place a product on the market as a food supplement because it seems “simpler”?
    In the short term, the food supplement regime is indeed less administratively demanding, but if the product in fact meets the definition of a medicinal product or is communicated as such, this approach is highly risky and may lead to regulatory intervention and a distribution ban.
  2. Is it possible to have the same active substance both in a food supplement and in a registered medicinal product?
    The law does not generally exclude such a situation, but each form must meet its own regulatory requirements, and the marketing of a food supplement must not use claims relating to the registered medicinal product, such as a reference to a specific diagnosis or treatment.
  3. Can a food supplement be distributed through the same channels as a medicinal product?
    Yes, food supplements are commonly distributed through pharmacies and wholesale distributors, but the legal regime for distribution is different and does not require authorisation from SÚKL; nevertheless, it is advisable to set up contractual arrangements and product quality so that they meet the expectations of pharmacies and patients. Our attorneys in Prague from a specialised law firm in Prague can provide essential assistance with this set-up.
Commercial and contractual set-up of distribution: Relationships with manufacturers, 3PL providers, and pharmacies

Several business models are used in the medicinal product distribution market, each with different implications for contractual relationships, liability, and regulatory risks. In addition to the classic wholesale distribution model—where the distributor purchases medicinal products from manufacturers and sells them to pharmacies or hospitals—there are also direct distribution models DTP (direct‑to‑pharmacy) and DTH (direct‑to‑hospital), in which the manufacturer supplies medicinal products directly to selected pharmacies or hospitals, while the distributor performs primarily a logistics function.

In its sector inquiry, the Office for the Protection of Competition (the Czech competition authority) stated that DTP/DTH models do not, a priori, have a negative impact on competition and may contribute to more effective control of the circulation of medicinal products and a reduction in re-exports; however, it is necessary to ensure that they are set up in a non-discriminatory and transparent manner.

For distributors and manufacturers alike, it is important to bear in mind that the way business models are structured can affect the position of different types of pharmacies, especially independent versus chain pharmacies, and that the regulator monitors potential market distortions, for example through excessive rebates or selective supply. 

In considerations regarding the pricing of reimbursed medicinal products, recommendations also appear to cap the trade margin of individual entities so that the position of pharmacies and hospitals is not worsened when purchasing these medicinal products. When preparing distribution agreements and bonus schemes, it is therefore advisable to assess not only contractual and regulatory aspects, but also competition-law aspects, ideally in cooperation with competition law specialists.

Contractual relationships with manufacturers, logistics partners, and customers

The contractual framework between the distributor, the manufacturer, logistics partners, and customers (pharmacies, hospitals, other distributors) is key to allocating liability, setting prices, bonuses, delivery terms, and addressing risks such as recalls, product spoilage, or counterfeits.

Agreements should reflect the specifics of the pharmaceutical market, including the distributor’s obligation to source medicinal products only from authorised persons and supply them only to authorised customers, which may require a process for verifying partners’ authorisations and a contractual commitment by partners to provide related documents and information.

When using a 3PL provider or other logistics partners, it is necessary to contractually address compliance with GDP requirements, including a detailed allocation of responsibility for temperature monitoring, record-keeping, deviation response, securing warehouses and means of transport, and enabling SÚKL inspections at the partner’s premises. 

The distributor, as the authorisation holder, cannot transfer regulatory responsibility to the 3PL and must therefore include in the agreements audit rights, reporting, indemnification, and clear procedures for crisis situations. Experience from a specialised law firm in Prague shows that unclear or merely formal agreements with logistics partners are often the weak link during SÚKL inspections.

Relationships with pharmacies and hospitals must also reflect the distributor’s obligation to ensure supplies of medicinal products in quantities and at time intervals corresponding to patients’ needs in the Czech Republic, especially for reimbursed products and products with limited availability status.

Amendments to the Czech Act on Medicinal Products emphasise distributors’ obligation to supply pharmacies with certain products within a short period, typically within two working days of receiving an order, which affects logistics planning and inventory levels. Failure to comply with these obligations may lead not only to sanctions, but also to reputational damage and the loss of business partners.

Risk table: Commercial and regulatory issues in the distribution of medicinal products

Potential issues

How a specialized Prague-based law firm can help (law firm contact details)

Unauthorized distribution without a valid SÚKL authorization : high fines and the risk of having business operations suspended

Comprehensive assessment of the planned model , preparation of the authorization application and communication with SÚKL so that distribution starts only in compliance with the law

Inadequately set contracts with 3PL providers and carriers : breach of GDP and unclear liability for damage

Drafting and review of contracts with logistics partners , setting liability, audit rights and crisis procedures in line with GDP and the Act on Medicinal Products

Borderline products between a medicinal product and a food supplement : risk of reclassification and a distribution ban

Assessment of the product portfolio , legal opinion on product classification, adjustments to labelling and marketing so that they correspond to the correct legal regime

Insufficient reporting and records towards SÚKL : sanctions and loss of the regulator’s trust

Setting internal processes and IT systems to meet reporting obligations , legal audit of data flows and representation during SÚKL inspections

Recalls and quality defects : high direct costs and reputational impact

Preparation of recall SOPs , contractual allocation of costs with manufacturers and customers, legal support in specific market withdrawals and defence against claims

If you want to be sure that your contractual setup for the distribution of medicinal products and food supplements reflects all regulatory, commercial and competition-law aspects, it is advisable to involve attorneys from a specialized Prague-based law firm already at the stage of preparing the business model; you can contact them via the law firm contact details.

Risks, sanctions, inspections and specifics of narcotic substances and international elements

As indicated above, the Act on Medicinal Products provides for high sanctions for legal entities and self-employed individuals for breaches of obligations in the manufacture and distribution of medicinal products. For unauthorized distribution without authorization, supplying medicinal products to unauthorized persons, failure to comply with Good Distribution Practice (GDP) rules, or failure to meet reporting obligations, SÚKL may impose a fine of up to CZK 20 million.

For specific qualified persons, such as the manufacturer’s qualified person or the distributor’s qualified person, personal fines of up to CZK 500,000 may be imposed for serious breaches of their obligations.

Legislative proposals and amendments in recent years have been moving towards further tightening of sanctions, in particular in connection with re-exports and insufficient record-keeping of medicinal products. For example, an amendment to the Act on Medicinal Products (effective from 1 January 2022) strengthened the importance of these obligations and increased the fine for failing to keep or retain records in pharmacies and by healthcare providers up to CZK 20 million, because failure to keep records may be used to conceal illegal re-exports of medicinal products. 

In practice, fines in the hundreds of thousands up to CZK 1.5 million have already been imposed for failure to record medicinal products, and it is expected that after the tightening of legislation the sanctions will be even stricter.

In addition to administrative sanctions, distributors also face significant civil liability for damages towards manufacturers, customers or patients if, as a result of a breach of obligations, medicinal products are damaged, become unavailable, or bodily harm occurs. 

In some cases, misconduct may also have criminal-law implications, for example if it involved intentional counterfeiting of medicinal products or knowingly circumventing anti-re-export measures. 

For this reason, in addition to legal and compliance setup it is essential to have adequate liability insurance, and a specialized Prague-based law firm itself has professional liability insurance coverage of up to CZK 400,000,000, which gives clients confidence when entrusting complex matters.

Inspections by SÚKL and other authorities: How they are conducted and what they focus on

Distributors of medicinal products can expect regular inspections by SÚKL, focusing both on verifying compliance with the conditions of the authorization and on ongoing monitoring of compliance with GDP, reporting obligations and other aspects. Inspections may be planned or unannounced, or triggered by a specific impulse, for example in connection with a quality defect, unavailability of a medicinal product, or suspicion of unauthorized re-export. 

During inspections, SÚKL has the right to enter the distributor’s premises, request documents, temperature records, delivery records, contracts with partners and other materials, and the distributor’s employees are obliged to provide cooperation.

In addition to SÚKL, distributors may also be inspected by other authorities, such as food supervision authorities (SZPI, SVS) in the case of food supplements, the Office for the Protection of Competition in connection with distribution models and pricing arrangements, or labour inspectorates in connection with occupational health and safety (OHS) and employment-law aspects if the distributor operates large warehouses. 

In the case of distribution of narcotic and psychotropic substances, the Inspectorate for Narcotic and Psychotropic Substances of the Ministry of Health becomes involved, supervising compliance with specific obligations in the handling of addictive substances. For management, it is therefore important to understand inspections not only as a one-off “test”, but as an ongoing mechanism that must be actively managed, for example through internal audits and regular training.

A specialized Prague-based law firm often helps clients both with preparation for an inspection, for example through a mock inspection, and with representation during the inspection itself and in any subsequent administrative proceedings. 

Attorneys can be present during meetings with SÚKL, help structure communication, argue disputed issues and, if necessary, prepare an appeal against a decision or an action before the courts. For a distributor, it is advantageous to have this “plan B” prepared in advance, rather than only at the moment when the first report with negative findings appears.

Distribution of narcotic and psychotropic substances and psychomodulatory substances

If a distributor plans to distribute medicinal products also containing narcotic and psychotropic substances, in addition to the general regime under the Act on Medicinal Products, special requirements apply under Act No. 167/1998 Coll., on addictive substances and on amendments to certain acts (the Addictive Substances Act).

The distribution of such medicinal products additionally requires an authorization to handle addictive substances issued by the Ministry of Health, which assesses compliance with strict security and record-keeping standards, including securing warehouses, restricting access to authorized persons and more detailed record-keeping obligations. Failure to comply with these regulations may, in addition to administrative sanctions, also have criminal-law implications, because handling addictive substances is strictly penalized.

As of 1 January 2025, Act No. 17/2024 Coll., on psychomodulatory substances and on amendments to certain acts, enters into force, introducing a new framework for handling a broader spectrum of psychomodulatory substances. 

As part of the changes, this includes, among other things, a new setup of administrative fees, which can no longer be paid using revenue stamps, but only by bank transfer, which is a practical detail affecting every entity applying for licences in this area.

For distributors planning to engage in this type of product as well, it is essential to assess the impact of the new legislation on their business model and to set up a compliance system that reflects both the Act on Medicinal Products and the regulations on addictive and psychomodulatory substances. 

In this specific area, interaction with the Police, the Customs Administration and international authorities is more intensive, and errors in records or security measures can have fundamental consequences. Attorneys from a specialized Prague-based law firm, drawing on experience with the regulation of addictive substances as well as international cross-border matters, help clients set up processes that will stand up not only to Czech authorities but also to foreign regulators, which is particularly important in cross-border distribution.

International elements and cross-border distribution of medicinal products

The distribution of medicinal products within the European Union is harmonized to a significant extent, especially as regards GDP requirements and mutual recognition of registrations; however, each Member State has its own regulation of certain procedural aspects and its own supervisory authorities.

A distributor based in the Czech Republic may, within the scope of its authorization, distribute medicinal products to other Member States, but must comply with both Czech and destination-country legislation, and in the case of medicinal products with restricted availability status, must notify SÚKL (the Czech State Institute for Drug Control) in advance of the intention to distribute abroad.

In some cases, it is appropriate to consider cooperation with local partners in the target countries or to use a network of international legal advisers. When exporting medicinal products to so-called third countries outside the EU, the requirements vary depending on the specific market and it is often necessary to meet additional registration, customs and import requirements, including submitting certificates of GDP compliance or issuing specific export certificates.

At the same time, it is necessary to take into account possible export restrictions for medicinal products considered critically important in the Czech Republic, where the law and implementing regulations set limits on re-export in order to protect availability for Czech patients. 

The distributor’s business strategy must therefore combine knowledge of local regulation with international requirements, which is a typical example of a complex issue where it pays to draw on the experience of attorneys with an international reach.

Questions: Risks, sanctions and international aspects
  1. Can sanctions be “justified” by the fact that it was an administrative error with no impact on patients? The Act on Medicinal Products often operates with strict (objective) liability, and the fact that no patient was directly harmed may not prevent a fine from being imposed, although it may play a role in determining its amount.
  2. Is an authorization to distribute issued in one Member State sufficient for distribution throughout the EU? In practice, an authorization is tied to a specific state and entity, but thanks to harmonized GDP rules and the EudraGMDP database, other states can relatively easily verify a distributor’s status; nevertheless, they may have specific requirements and it is always necessary to verify the regulation of the destination country.
  3. What are the specifics of distributing narcotic and psychotropic substances and psychomodulatory substances? Here, the legal regime combines pharmaceutical, criminal and international elements, and any improvisation is highly risky. In these situations, it is always recommended to work with a detailed legal assessment, which can be provided by specialists from a specialized Prague-based law firm via the office contact.

Final summary

The distribution of medicinal products in the Czech Republic is a complex regulated activity that requires not only formal authorization from SÚKL, but also long-term and systematic compliance with Good Distribution Practice requirements, reporting obligations and other legislative and regulatory rules. 

Tightening sanctions, a growing emphasis on transparent record-keeping and reporting, and pressure to ensure the availability of medicinal products for patients in the Czech Republic increase the demands on distributors and their management, and errors that in other sectors would mean only an administrative complication may here lead to fines in the millions of Czech crowns or even to the withdrawal of the distribution authorization.

At the same time, food supplements, although often commercially attractive and subject to more flexible marketing, represent their own regulatory world as foods, with a notification obligation to the Ministry of Health, compliance with food law and strict rules for health and nutrition claims; incorrect presentation or composition may lead to reclassification as a medicinal product and retroactive impacts on distribution.

For entrepreneurs, investors and top management, it is therefore crucial to understand that the decision to enter the segment of distributing medicinal products or food supplements is not only a matter of business potential, but also a choice regarding the level of regulatory burden, investments in infrastructure, IT and compliance, and the willingness to bear the associated risks. 

In practice, the two worlds also often overlap, for example when one entity distributes both registered medicinal products and food supplements, or when the same logistics and sales channels are used for both types of products, which brings additional layers of complexity. The legal reality tends to be more complicated than it appears at first glance – an apparently simple step, such as choosing a product designation or setting up an agreement with a logistics partner, may have implications in liability, criminal, tax and competition law and affect the entire business model.

If you do not want to risk errors, losses, delays or fines, it is safer to address issues of distributing medicinal products and food supplements with experts who understand pharmaceutical, food and commercial law and can connect the legal framework with real market practice. 

Attorneys from a specialized Prague-based law firm have practical experience with these matters; they can prepare and review licensing documentation, set up contractual relationships with manufacturers, pharmacies and 3PL partners, assist with the classification and marketing of food supplements, represent you in inspections by SÚKL and other authorities, and provide expert opinions also in cross-border transactions thanks to a network of international legal advisers. 

If you are considering entering pharmaceutical distribution in the Czech Republic or want to review your existing model, you can safely turn to a specialized Prague-based law firm via the office contact.

Key questions on pharmaceutical distribution in the Czech Republic: How to obtain a permit and how it differs from food supplements
  1. How long does it take to obtain a permit for pharmaceutical distribution in the Czech Republic, and when can I realistically start trading?
    Within the statutory time limit, SÚKL must decide on a complete application within 90 days; in practice, however, you should expect a total timeframe of three to six months depending on how well the documentation is prepared and the outcome of the inspection. You may trade in medicinal products only after the decision becomes final and the distributor code is assigned; any distribution before that is illegal and subject to sanctions. If you want to speed up the process and minimize the risk of delays, it is worth contacting attorneys from a specialized Prague-based law firm via the office contact.
  2. Do I need a SÚKL permit also for distributing food supplements if I sell them to pharmacies?
    No. Food supplements are foods, and their distribution is not subject to a SÚKL permit for the distribution of medicinal products; however, you must comply with food law requirements, including registration of a food business operator, HACCP, and notification of supplements with the Ministry of Health. If you also distribute medicinal products, it is advisable to set up internal processes and contracts so that the regimes for medicinal products and supplements are clearly separated—something attorneys from a specialized Prague-based law firm can help you with after you reach out via the office contact.
  3. What are the biggest risks if I label a product as a food supplement but present it as a “treatment” for a specific disease?
    The biggest risk is that the supervisory authorities will reclassify the product as a medicinal product, which may lead to a ban on placing it on the market, an obligation to withdraw the product from distribution, destruction of stock, and administrative penalties for placing an unregistered medicinal product on the market, with fines of up to CZK 20 million. In addition, there is a risk of private-law claims and reputational damage, so it is advisable to consult your marketing strategy and the wording of labels in advance with attorneys from a specialized Prague-based law firm via the office contact.
  4. What sanctions do I face if I fail to comply with Good Distribution Practice rules or do not report data to SÚKL on time?
    For breaches of Good Distribution Practice rules, failure to meet reporting obligations, or failure to keep records, SÚKL may impose fines of up to CZK 20 million and, in extreme cases, restrict or revoke the distribution permit; individual qualified persons may receive personal fines of up to CZK 500,000. Assessing risks and setting up processes so you avoid these situations or remedy them in time can be ensured by a specialized Prague-based law firm if you contact them in good time via the office contact.
  5. I plan to distribute medicinal products containing narcotic and psychotropic substances as well—what additional requirements should I expect?
    In addition to the general SÚKL permit for pharmaceutical distribution, you will need a special permit from the Ministry of Health to handle addictive substances under the Addictive Substances Act, and you must meet strict security, record-keeping, and control standards for addictive substances. Given that this area combines pharmaceutical and criminal regulation and, from 1 January 2025, also the regime for psychomodulatory substances, it is advisable to prepare the project in detail with the support of a specialized Prague-based law firm, for example via the office contact.
  6. How will a specialized Prague-based law firm help if a SÚKL inspection is already underway and inspectors have identified deficiencies?
    Attorneys from a specialized Prague-based law firm can attend meetings with SÚKL, help formulate responses to the inspection report, propose corrective measures, negotiate the scope of sanctions, and, if necessary, prepare an appeal or a court action against the decision. The earlier you involve them—ideally at the first signs of problems—the greater the chance of minimizing the impact on your business; you can contact them via the office contact.

Notice: The information contained in this article is of a general informational nature only and is intended for basic guidance on the topic under the legal framework as of 2026. Although we take the utmost care to ensure accuracy, legal regulations and their interpretation evolve over time. We are ARROWS advokátní kancelář, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client protection we maintain professional liability insurance with a limit of CZK 400,000,000. To verify the current wording of regulations and their application to your specific situation, it is necessary to contact ARROWS advokátní kancelář directly (office@arws.cz). We accept no liability for any damages arising from the independent use of the information in this article without prior individual legal consultation.

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