Permission to distribute medicines and supplements in Czechia and the European Union

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.

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)

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.

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.

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.

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 consultation@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. 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).
12. 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 consultation@arws.cz.

Read also:

• Czech Trade Licence (Živnostenské oprávnění): What Foreign Companies Must Know
• 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