Permission to distribute medicines and supplements in Czechia and the European Union: Practical guide

If you are planning to distribute medicinal products or food supplements in the Czech Republic, you must meet a number of strict legal requirements. Although the process may appear administratively straightforward, in practice it involves legislative pitfalls under Czech law. In this article, you will learn how the process works under the Czech Act on Medicinal Products, what to expect, and what risks you face if you overlook anything. You will find specific steps as well as practical advice.

Quick summary

• Authorisation is mandatory : Without an authorisation issued by the State Institute for Drug Control (SÚKL) in the Czech Republic, you cannot legally distribute medicinal products. Unauthorised distribution may result in penalties of up to CZK 20 million.
• The process has three main phases : Obtaining a trade licence, submitting an application to SÚKL (the statutory decision period is 90 days), and an on-site inspection verifying compliance with Good Distribution Practice (GDP) requirements under Czech and EU rules.
• Details matter : The process involves a number of legal pitfalls and links to EU regulations—therefore it is advisable to seek guidance from specialists at ARROWS advokátní kancelář, a Prague-based law firm.
• Common mistakes: SÚKL regularly identifies deficiencies in documentation, storage (temperature mapping) or the medicinal product recall system. Many applicants lack Standard Operating Procedures (SOPs) or have SOPs that are insufficient.

What exactly does “distribution of medicinal products” mean?

Distribution of medicinal products is not ordinary buying and selling of goods. Under the Czech Act on Pharmaceuticals, it covers all activities related to procurement, storage, supply, import or export of medicinal products, except for dispensing to patients. You need authorisation regardless of whether the activity is carried out for consideration or free of charge.

It is necessary to distinguish legally between medicinal products (medicines) and food supplements. Although they may look similar, entirely different legal regulations apply. While medicinal products are regulated by SÚKL, food supplements fall under food law and the supervision of the Czech Agriculture and Food Inspection Authority (SZPI).

What are the basic requirements for distributing medicinal products?

Obtaining authorisation to distribute medicinal products requires meeting the conditions of so-called Good Distribution Practice (GDP). SÚKL strictly verifies these requirements under Czech legislation. 

A key requirement is suitable storage premises that allow medicinal products to be stored safely, and a validated system for monitoring temperature and humidity. You must also ensure that the premises meet technical standards. This includes security against unauthorised access and protection against physical damage to the goods. 

If you also plan to distribute narcotic and psychotropic substances, this additionally requires a permit to handle such substances from the Czech Ministry of Health and compliance with strict security standards.

A system for withdrawing medicinal products from the market (recall system) is also essential. You must be able to respond immediately to quality defects or suspected counterfeits. The distributor also has a duty to cooperate in the area of pharmacovigilance.

Related questions on the distribution of medicinal products and supplements

1. Do I need to have my own premises or can I rent them? Yes, distribution authorisation is tied to specific approved storage premises. The application must include evidence of the legal title to use the premises (typically a lease agreement or an extract from the Czech Land Registry).
2. How often do I have to check the temperature in the warehouse? Temperature must be monitored continuously. In practice, automatic data loggers are used to measure temperature at regular intervals. The system must be set up to alert you to any deviation (alarms).
3. What is pharmacovigilance for distributors? Although a distributor does not perform safety assessment like a manufacturer, it must record and forward any report of a suspected adverse reaction or a quality defect it receives to the relevant parties (the marketing authorisation holder, SÚKL).

Step 1: Trade licence

The first step is obtaining authorisation to conduct business. Distribution of medicinal products falls under an unregulated trade (line of business: wholesale and retail), however the distribution of medicinal products itself is regulated by a special law in the Czech Republic. You notify the trade at the Trade Licensing Office.

In practice, this means you obtain an identification number (IČO) and formal authorisation to do business. The trade licence itself does not entitle you to start distributing medicinal products. For that, you must obtain authorisation from SÚKL, and commencing distribution solely on the basis of a trade licence would be unlawful under Czech law.

Step 2: Submitting an application for authorisation to distribute medicinal products

This is the key phase. The application is submitted to the State Institute for Drug Control (SÚKL) in the Czech Republic. The application must be filed on the prescribed form (usually electronically or via a data box) and must include a number of mandatory annexes:

• Proof of the right to use the premises and a floor plan of the premises,
• Proof of payment of the administrative fee (the amount is governed by ),
• Evidence of professional competence of the qualified person (if required for specific activities),
• Standard Operating Procedures (SOPs) – a key document describing all processes.

SÚKL assesses whether you are able to ensure handling of medicinal products in compliance with Czech law. If the documents are incomplete, SÚKL will request supplementation and the proceedings will be suspended.

Related questions – submitting an application to SÚKL

4. How long does SÚKL take to decide on an application? The statutory time limit for issuing a decision is 90 days from the submission of a complete application. If the authority asks you to remedy deficiencies, the time limit is suspended and the process is extended.
5. What happens if I do not supplement the application? If you do not remedy the defects in the application within the set time limit, SÚKL will discontinue the proceedings. You would then have to start again from scratch and pay the administrative fee again.
6. Can I start distributing before the decision is issued? No. Distribution is permitted only once the decision granting the distribution authorisation becomes final and effective. Starting prematurely is an administrative offence subject to a high fine under Czech law.

Step 3: On-site inspection

As part of the proceedings for issuing the authorisation, SÚKL typically carries out an on-site inspection at your warehouses in the Czech Republic. Inspectors verify whether reality matches the paperwork. They check the warehouse equipment, thermometer calibration, cleanliness, security, and staff knowledge.

Inspectors focus on whether you have implemented and maintain functional Standard Operating Procedures (SOPs). A common deficiency is the absence of warehouse temperature mapping or errors in the system for receipt and inspection of medicinal products. An important part is also checking compliance with the safety features regulation (FMD – Falsified Medicines Directive) for verifying the authenticity of medicines.

Step 4: Registration in databases and start of operations

After a successful inspection and once the final decision is issued, SÚKL will assign you a distributor code and register you in the national database as well as in the pan-European EudraGMDP database. Only at this point can you legally begin purchasing and selling medicinal products in the Czech Republic.

You must keep detailed records of every transaction – batch number, expiry date, quantity, supplier, customer. Records must be retained for 5 years and must be available at any time for inspection by SÚKL.

Related questions – After the authorisation is issued

7. How long is the authorisation valid? The authorisation is usually issued for an indefinite period. However, if the conditions change (e.g., a change of warehouse, a change of the person responsible for the warehouse), you must apply for an amendment to the authorisation.
8. What obligations do I have when selling? You may supply medicinal products only to authorised persons – i.e., pharmacies, other distributors, or healthcare providers. Supplying an unauthorised entity is a serious breach of Czech law.
9. What if I want to distribute food supplements?  You do not need an authorisation from SÚKL for food supplements (they are not medicinal products). However, you must comply with food law requirements, implement an HACCP system, and, where applicable, fulfil a notification obligation towards the Ministry of Agriculture of the Czech Republic.

Specifics for food supplements

Distribution of food supplements is subject to a different regime than medicinal products. From a legal perspective, food supplements are foods. The supervisory authority is SZPI (the Czech Agriculture and Food Inspection Authority).

Correct labelling is key. For food supplements, so-called medicinal claims are strictly prohibited – you must not claim or imply that a food supplement treats or prevents disease. Only so-called health claims approved by the European Commission are permitted.

Pan-European distribution – the rules of the game in the EU

If you hold a distribution authorisation in the Czech Republic (so-called WDA – Wholesale Distribution Authorization), the principle of free movement of goods applies, but with important limitations.

Your Czech authorisation is recognised within the EU in the sense that partners in the EU can find you in the EudraGMDP database and can sell goods to you. However, if you want to establish a warehouse in another Member State, you must obtain an authorisation from the local regulator.

If you only want to supply medicinal products from a Czech warehouse to other EU countries, you must verify whether the given medicine is authorised in the destination country or whether local legislation allows its import. Distribution itself is governed by Good Distribution Practice (GDP) rules, which are harmonised across the EU.

Attorneys from ARROWS advokátní kancelář handle this agenda and have experience in building international structures. If you want to distribute in the EU, contact us at office@arws.cz.

Basic obligations of a distributor

The holder of a distribution authorisation has a number of ongoing obligations under Czech law:

• Purchase medicinal products only from authorised persons (manufacturers or other distributors).
• Supply medicinal products only to authorised persons (pharmacies, distributors, healthcare facilities).
• Regularly report distribution data to SÚKL (reports on volumes supplied).
• Ensure a system for recalling medicinal products from the market in the event of a defect.
• Verify safety features on medicine packaging (counterfeit prevention).

Table of risks and possible sanctions

What to do if SÚKL carries out an inspection?

During an inspection, you have the right to legal assistance. SÚKL inspectors check compliance with the Czech Act on Medicinal Products and GDP guidelines. It is crucial to have all documentation in order and to cooperate.

In the event of serious findings, SÚKL may initiate misdemeanour proceedings or even suspend the distribution authorisation. You may file objections to the inspection report.

The Czech legal team at ARROWS advokátní kancelář can represent you during the inspection, oversee compliance with your procedural rights, and help draft objections to the inspection report.

Most common mistakes when obtaining a distribution authorisation

10. Underestimating warehouse preparation: The warehouse must be completed and fully equipped (including temperature monitoring) at the time of the inspection—not only “after the permit is granted”.
11. Copying SOPs: Using generic guideline templates downloaded from the internet that do not reflect the reality of your operations. SÚKL (the Czech State Institute for Drug Control) can easily detect this.
12. Mixing medicinal products and supplements: Incorrect product classification and applying the wrong legal regulations under Czech law (e.g., treating a food supplement as a medicinal product and vice versa).
13. Lack of awareness of obligations after obtaining the permit: Many companies do not know they must regularly submit distribution reports to SÚKL in the Czech Republic, which leads to unnecessary fines.

Obtaining a permit to distribute medicinal products in the Czech Republic is a highly formalised process that requires precise preparation and a thorough understanding of the Czech Act on Pharmaceuticals. Even a minor error in the documentation or warehouse setup can result in months of delay or the application being rejected.

The attorneys at ARROWS, a Prague-based law firm, specialise in pharmaceutical law under Czech legislation. We prepare complete documentation, represent clients before SÚKL, and carry out readiness audits for inspections. Thanks to our experience, we minimise risks and save you time.

If you want to be sure your business stands on solid legal foundations in the Czech Republic, contact us. Email office@arws.cz.

Related questions – Most common legal queries on distribution

14. Who supervises the distribution of food supplements? Food supplements are supervised by the State Agricultural and Food Inspection Authority (SZPI) in the Czech Republic, not SÚKL. SÚKL deals only with medicinal products.
15. What is the fine for distribution without a permit?  The Czech Act on Pharmaceuticals allows for a fine of up to CZK 20,000,000. This is one of the most strictly penalised administrative offences.
16. Can I store medicines and food supplements together? Yes, but they must be clearly separated and labelled to prevent mix-ups. Medicinal products are subject to a stricter storage and record-keeping regime under Czech law.
17. Do I need a lawyer for an application to SÚKL? The law does not require it, but given the complexity of the documentation (SOPs) and the administrative procedure, expert legal assistance is highly recommended for a smooth process.

Notice: The information contained in this article is of a general informational nature only and is intended for basic guidance on the topic. To verify the current wording of the regulations and their application to your specific situation, it is necessary to contact ARROWS, a Prague-based law firm (office@arws.cz).

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• Operating Without a Licence in the Czech Republic: Legal Consequences Explained
• Compliance audits: How to conduct an internal audit before the authorities arrive
• How to prepare for administrative proceedings at the CNB: Legal and documentation minimum
• Setting Up a Czech Subsidiary: Key Legal and Tax Considerations