Medicinal Product Distribution Licensing and Compliance in Czechia
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Doing business in the distribution of medicinal products is not ordinary goods trading. The State Institute for Drug Control (SÚKL) and ÚSKVBL decide who is allowed to distribute medicinal products. The licensing process is subject to strict requirements under the Act on Medicinal Products. You must understand the obligations as well as the penalties that may apply in the event of a breach of the rules, including new measures effective in 2026.
Table of contents
Key takeaways
- A licence is absolutely mandatory: Without a final decision of SÚKL, you cannot legally distribute medicinal products in the Czech Republic.
- The process takes at least 90 days and includes obtaining a regulated trade licence, filing an application with SÚKL, an on-site inspection, and entry in a public database.
- The basic conditions for Good Distribution Practice (GDP) are based on European Commission guidelines and apply in the Czech Republic in the same way as in other EU Member States.
- Missing temperature mapping or inadequate standard operating procedures may lead to the application being rejected or the proceedings being suspended.
What exactly the distribution of medicinal products means
Distribution of medicinal products is not simply buying and selling. The Czech Act on Medicinal Products defines distribution as all activities related to procuring, storing, supplying, importing, or exporting medicinal products. The exception is dispensing directly to patients, which is an activity reserved for pharmacies. A distributor is an intermediary in the chain between the manufacturer and a pharmacy or healthcare provider.
Importantly, you must hold a licence regardless of whether you perform the activity for consideration or free of charge. Even donating medicinal products to a hospital requires the donor to meet the statutory conditions for handling medicinal products; otherwise, they risk penalties.
Distribution also includes exporting medicinal products abroad. If you wish to export medicinal products to EU countries, you must follow the rules on the free movement of goods, subject to restrictions driven by the current availability of medicinal products in the Czech Republic. Exports outside the EU are subject to customs regulations and specific rules under the Czech Act on Medicinal Products.
The law strictly distinguishes between the distribution of human medicinal products and veterinary medicinal products. Veterinary distribution is governed by the EU Regulation on veterinary medicinal products and Czech legislation, with the competent authority being ÚSKVBL.
Legal framework and powers of supervisory authorities
The key legislation is the Czech Act on Medicinal Products and the implementing decree on the manufacture and distribution of medicinal products. For Good Distribution Practice, the European Commission Guidelines on Good Distribution Practice of medicinal products for human use are essential.
SÚKL maintains a public database of all entities holding a distribution authorisation, and it is linked to the European EudraGMDP database. If you hold a Czech authorisation, European partners will find your record in this register. Loss of authorisation or serious inspection findings are visible in the system to all medicines agencies in the EU.
SÚKL also monitors supplies of medicinal products, and distributors are required to report supply data electronically. Since 2024, stricter rules have applied to reporting stock levels and supplies for medicinal products with limited availability; by 2026, this is established practice subject to strict oversight.
When additional special permits are required
If you want to distribute narcotic and psychotropic substances, a permit from SÚKL is not sufficient. You must obtain a handling permit under the Czech Addictive Substances Act, issued by the Ministry of Health.
These proceedings require compliance with strict security standards, clean criminal records of statutory bodies, and keeping a special register book. Requirements include, for example, safes, bars, and electronic security connected to a central monitoring station.
The attorneys at ARROWS, a Prague-based law firm, note that obtaining a permit to handle narcotic and psychotropic substances is a separate administrative procedure that may extend the overall process of starting distribution.
Process of obtaining a distribution authorisation
Step 1: Trade licence
The first step is obtaining a trade licence. Distribution of medicinal products falls under a regulated trade or a concession, depending on the exact scope of the activity. The entrepreneur must have the relevant business activity corresponding to distribution entered in the Commercial Register.
A trade licence alone does not entitle you to purchase and sell medicinal products. A decision of SÚKL is essential for that.
Step 2: Filing an application for a distribution authorisation with SÚKL
The application is filed with the State Institute for Drug Control (SÚKL) on the prescribed form, typically electronically via a data box or SÚKL’s interactive form. The statutory time limit for issuing a decision is 90 days from submission of a complete application.
Key elements of the application and mandatory annexes include:
- Proof of legal personality (extract from the Commercial Register).
- Documentation of storage premises (floor plans, technical report).
- Agreement with a qualified person.
- Standard operating procedures (SOPs).
- Proof of the right to use the premises.
- Payment of the administrative fee and reimbursement of costs.
The attorneys at ARROWS, a Prague-based law firm, recommend paying maximum attention to preparing SOPs, because templates from the internet often do not reflect the reality of a specific warehouse.
Most common questions when preparing the application
1. What deadline do I have to remedy deficiencies if SÚKL finds defects?
SÚKL will set a reasonable deadline in the decision suspending the proceedings, usually 15 to 30 days. If you do not remedy the defects, the proceedings will be discontinued.
2. Can I start distributing before the decision is issued?
No. Distribution is permitted only from the date the decision granting the distribution authorisation becomes final and effective. Starting early is an administrative offence with a high penalty.
Step 3: On-site inspection
Before issuing the authorisation, SÚKL will carry out an on-site inspection to verify that the application matches reality. Inspectors check the suitability of the premises, the functionality of thermometers, warehouse security, and staff knowledge.
Inspectors focus on whether standard operating procedures are actually implemented. Paper perfection is not enough if the warehouse worker does not know how to handle a damaged shipment.
Step 4: Entry in databases and commencement of operations
After the decision becomes final and effective, SÚKL assigns the distributor a code and enters it into the national register and the EudraGMDP database. From that moment, you can legally trade in medicinal products.
Requirements for Good Distribution Practice (GDP)
A distributor’s activities are governed by the rules of Good Distribution Practice (GDP). These requirements are harmonised across the EU and are implemented in the Czech Republic through the decree on the manufacture and distribution of medicinal products.
GDP regulates in particular:
Premises and equipment. The warehouse must ensure that medicinal products are not exposed to temperature fluctuations, humidity, or light. For thermolabile medicinal products, a cold chain with continuous monitoring and an alarm system is required.
Qualified person. The distributor must have a qualified person with the relevant education permanently available who guarantees compliance with GDP.
Receipt and inspection of medicinal products. Each delivery must be checked, including packaging integrity, batch number and expiry date. For human medicinal products, safety features must be verified.
Records and traceability (Traceability). You must be able to trace the route of each batch of medicinal product at any time, from receipt to dispatch. In the event of a product recall, the distributor must be able to immediately identify customers and recall the product.
Prevention of falsified medicines (FMD). In specified cases, distributors must verify unique identifiers (2D codes) on the packaging and decommission them from the system in situations set out in the regulation.
Who you can and cannot distribute to
The Czech Act on Medicinal Products precisely defines the circle of customers. You may distribute only to other distributors, pharmacies, healthcare service providers, sellers of restricted medicinal products, and veterinary surgeons.
A distributor must not supply medicinal products directly to natural persons, as this would be considered unauthorised provision of pharmacy care.
The attorneys of ARROWS, a Prague-based law firm, handle cases where distributors supply, for example, aesthetic clinics that do not have the status of a healthcare service provider authorised to purchase medicinal products. Such conduct is subject to sanctions.
Distributor obligations – what is expected in practice
Obtaining the licence does not end the obligations; on the contrary, it is where they begin:
Distribution reporting (Reporting). The distributor is obliged to provide SÚKL (the Czech State Institute for Drug Control) with data on the volume of medicinal products it has distributed. In 2026, emphasis is placed on real-time reporting for medicines marked as “limited availability”.
Ensuring availability. An amendment to the Czech Act on Medicinal Products imposes on distributors the obligation to deliver a medicinal product to a pharmacy within 2 business days of receiving the order.
Purchasing only from authorised persons. Medicinal products may be sourced only from manufacturers or other holders of a distribution authorisation.
Cooperation during inspections. SÚKL may carry out inspections at any time, including unannounced.
Safety and insurance. The law requires the distributor to arrange liability insurance for damage caused in connection with distribution activities.
Sanctions for breaches – what you risk
The Czech Act on Medicinal Products provides for high sanctions for legal entities and self-employed individuals. SÚKL may impose a fine of up to CZK 20,000,000.
The most common offences include unauthorised distribution without a licence, supply to an unauthorised person, or failure to comply with reporting obligations. In addition to financial penalties, suspension or revocation of the distribution authorisation may be imposed, which for a company means the de facto liquidation of its business.
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Potential issues |
How ARROWS helps (office@arws.cz) |
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Distribution authorisation proceedings |
Comprehensive legal support in preparing the application, review of SOPs and agreements with the qualified person. |
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Preparation for a SÚKL inspection |
A “mock audit” trial run, review of compliance of premises and documentation with GDP requirements. |
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Administrative proceedings regarding a fine |
Representation in administrative proceedings before SÚKL, filing appeals and administrative actions. |
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Reporting and compliance |
Setting up internal processes to meet reporting obligations and prevent sanctions. |
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Agreements with partners |
Preparation of distribution agreements, logistics agreements and quality agreements (Quality Agreements). |
Distribution of medicinal products in an international context
A distribution authorisation issued by SÚKL is valid in the Czech Republic, but it is recognised within the EU as evidence of meeting GDP standards. If you want to supply from a Czech warehouse to other EU countries, this is an intra-Community supply of goods and you must comply with the legislation of the destination country.
If you want to establish a warehouse in another Member State, you must obtain a distribution authorisation from the local medicines agency.
In 2026, a mechanism applies in the Czech Republic that allows the Ministry of Health to temporarily prohibit the distribution of specific medicinal products abroad. Breach of this prohibition is strictly penalised.
Most common mistakes in practice
1. Underestimating warehouse preparation. The premises must be ready at the time of filing the application or at the latest at the time of inspection. Missing calibrations or temperature mapping is a reason for the authorisation not to be granted.
2. Formal SOPs. Using templates that do not reflect the company’s actual processes is a mistake, because inspectors verify employees’ knowledge of procedures.
3. Ignoring reporting obligations. Failure to meet deadlines for reporting distributed medicinal products leads to automatic sanctions.
4. Insufficient verification of partners. Supplying a medicine to an entity that is not authorised to purchase it is the distributor’s responsibility, and regular checks in databases are necessary.
Final summary
Distribution of medicinal products is a highly regulated sector where the protection of public health takes precedence over free trade. SÚKL (the Czech State Institute for Drug Control) strictly enforces compliance with GDP and the Czech Act on Medicinal Products. Success in this business requires not only commercial drive, but above all precise compliance.
The key is to start correctly: have suitable premises, trained staff, realistic and functional standard operating procedures, and legal certainty at every step.
If you are not sure whether your company meets all requirements, or you are facing an inspection, do not take risks. The attorneys of ARROWS, a Prague-based law firm, have long focused on pharmaceutical law.
If you have specific questions or want to address a situation in your company, contact the attorneys of ARROWS, a Prague-based law firm, at office@arws.cz.
FAQ: Most common questions on the distribution of medicinal products
1. How long does the entire process of obtaining a distribution authorisation take?
The statutory time limit for SÚKL is 90 days. In practice, expect 3 to 6 months depending on how prepared your premises and documentation are and on inspectors’ workload.
2. Is it possible to distribute medicinal products without a licence if I am a small company?
No, the law does not distinguish by company size. Distribution without a licence is a serious administrative offence with a fine of up to CZK 20 million.
3. As a distributor, can I export medicines abroad?
Yes, but with restrictions. You must comply with export rules and verify whether the specific medicine is on the list of medicinal products whose export is prohibited by the Ministry of Health.
4. What does the FMD obligation (anti-counterfeiting directive) mean?
You must have hardware and software for scanning 2D codes on medicine boxes and be connected to the National System for Verification of the Authenticity of Medicinal Products (NSOL).
5. What should you do if SÚKL identifies deficiencies during an inspection?
SÚKL will ask you to remedy them and set a deadline. You must submit a corrective and preventive action plan (CAPA) and subsequently provide evidence that it has been implemented. ARROWS’ Prague-based attorneys can assist you with drafting the CAPA and communicating with the authority at office@arws.cz.
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 (office@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.
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