Marketing Authorisation and Market Entry for Medicinal Products in Czechia

Mgr. Vojtěch Sucharda
Mgr. Vojtěch Sucharda
30.3.2026 | ARROWS law firm

Placing a medicinal product on the market in the Czech Republic is not merely a medical matter – it is a complex legal and regulatory process with a clearly defined framework. Foreign companies often underestimate the number of obligations involved: from choosing the correct type of marketing authorisation procedure, through dealings with Czech authorities, to post-marketing obligations. In this article, we explain the steps pharmaceutical companies most commonly go through, the risks they encounter, and why it is not sensible to improvise.

In the image, we see an expert discussing the topic of placing a medicinal product on the market.

Key takeaways

  • Foreign pharmaceutical companies choose between centralised authorisation (via the EMA) or a national/decentralised procedure via .
  • Preparing and filing an application requires flawless documentation in the eCTD format and compliance with precise regulatory requirements – an error in preparation costs months of time and significant financial resources.
  • Once placed on the market, new legal obligations arise: , supply reporting, compliance with price regulation and reimbursement conditions.
  • Uncoordinated steps, incorrect interpretation of regulations, or underestimating the Czech Act on Medicinal Products lead to delays, refusal of authorisation, or sanctions.
  • The attorneys at ARROWS, a Prague-based law firm, handle the above situations, understand the practice of Czech regulators, and ensure that your market entry proceeds without unnecessary legal obstacles.

Two main routes: Centralised authorisation and the national procedure

A foreign pharmaceutical company essentially has two main options for obtaining a marketing authorisation decision in the Czech Republic. The choice between them depends on the type of medicinal product and the business strategy, and it has a fundamental impact on timing, costs, and administrative burden.

This route must be used mandatorily by companies developing biotechnology medicinal products, advanced therapy medicinal products, orphan medicines, or new medicines for specific diseases. The centralised procedure is conducted via the European Medicines Agency (EMA) based in Amsterdam. If you obtain centralised approval, the medicinal product is automatically authorised in all EU Member States, including the Czech Republic.

Procedures involving Member States are carried out in cooperation with national medicines agencies; in the Czech Republic, this is the State Institute for Drug Control (SÚKL). We distinguish three situations:

  • National procedure: Only for the Czech Republic, if the medicinal product is not authorised elsewhere in the EU.
  • Decentralised procedure (DCP): Simultaneous authorisation in multiple EU countries where the medicinal product is not yet authorised. One country (the Reference Member State – RMS) leads the assessment.
  • Mutual recognition procedure (MRP): The medicinal product is already authorised in one EU country and that authorisation is recognised in other countries.

A German or Austrian company often believes that authorisation in its home country alone is sufficient, but this is a common misconception. Each route has its own timeline and specific fees. A formal recognition process (MRP) must be completed, and national texts such as the packaging and package leaflet must be prepared in Czech.

What it means to prepare a high-quality submission

For SÚKL or the EMA to process the authorisation, you must submit documentation in the eCTD (Electronic Common Technical Document) format. This is a standardised package of administrative, quality (CMC), non-clinical and clinical documentation.

If texts such as the Summary of Product Characteristics or the Package Leaflet are of poor quality or terminologically incorrect, SÚKL will suspend the proceedings and request corrections, which unnecessarily prolongs the process. Czech requirements call for Czech-language versions of these documents and the packaging texts.

In addition to the medicinal product authorisation itself, you must meet manufacturing and distribution requirements:

  • Good Manufacturing Practice (GMP): The manufacturer must have a valid . If you import a medicinal product from countries outside the EU, you must have an EU batch release site and a Qualified Person (QP) who certifies each batch for the EU market.
  • Good Distribution Practice (GDP): For physical distribution within the Czech Republic, you must have  or a contractual distributor holding a valid authorisation issued by SÚKL.
Related questions

1. What happens if I submit incomplete documentation?
The regulator (SÚKL) will request supplementation and set a deadline. During this time, the time limit for issuing a decision is suspended (the so-called clock-stop). Frequent suspensions delay market entry and give competitors room to manoeuvre.

2. Do I need to have a Qualified Person (QP) physically in the Czech Republic?
The QP for batch release must be within the EU/EEA. It does not necessarily have to be in the Czech Republic if you import from another EU country.

3. How long does the assessment of the submission itself take?
In the centralised procedure as well as DCP/MRP, the net assessment time is 210 days. In the national procedure, SÚKL also has a 210-day time limit. However, the actual time-to-market is longer by the time the applicant spends preparing responses to the Institute’s comments (clock-stop), which in practice often means 12 months or more.

Regulatory requirements in the Czech Republic and the role of SÚKL

The State Institute for Drug Control (SÚKL) is a key partner and supervisory authority. SÚKL actively assesses authorisation documentation, approves texts, sets prices and reimbursement, and carries out inspections.

When you file an application in the Czech Republic, you must address the specifics under Act No. 378/2007 Coll., on Medicinal Products. The main areas include:

  • Packaging and labelling: Must comply with Decree No. 228/2008 Coll. Information on the packaging must be in Czech, or alternatively in Slovak, but the package leaflet must always be in Czech. The packaging must include specific  for authenticity verification.
  • Price and reimbursement setting: In the Czech Republic, this is a completely separate administrative procedure, also conducted by SÚKL (Price and Reimbursement Section). Without reimbursement from public health insurance, a medicinal product is often financially inaccessible for Czech patients.
  • Pharmacovigilance: You must demonstrate that you have a functioning safety monitoring system.

Our attorneys in Prague at ARROWS understand these processes and help clients prevent formal errors that could lead to the application being refused.

Clinical assessment prior to authorisation

If you plan to conduct clinical trials in the Czech Republic, for example a Phase III study to obtain data for authorisation, this process is governed by EU Regulation No. 536/2014 (CTR). The application is submitted centrally via the CTIS (Clinical Trials Information System) portal.

The approval process includes assessment by SÚKL and the relevant Ethics Committee. SÚKL assesses the scientific and quality part, while the ethics committee oversees the protection of trial subjects’ rights. Contracts with sites and investigators must be legally structured under Czech law, including sponsor liability insurance for the study.

Pharmacovigilance and post-marketing obligations

Obtaining a Marketing Authorisation does not mean the process is over. The obligations of the Marketing Authorisation Holder (MAH) then begin, and breaches are strictly sanctioned.

Every marketing authorisation holder must have a Qualified Person Responsible for Pharmacovigilance (QPPV) based in the EU. For the Czech Republic, a Czech-speaking pharmacovigilance contact person is also often required if the QPPV does not speak Czech, to ensure swift communication with SÚKL (the Czech State Institute for Drug Control). Obligations include collecting and reporting suspected adverse reactions to the EudraVigilance database, monitoring scientific literature, and submitting Periodic Safety Update Reports (PSURs).

Under the Czech Act on Medicinal Products, you are required to notify SÚKL of the launch, interruption, and discontinuation of placing a medicinal product on the market. There is also an obligation to regularly report volumes supplied to pharmacies and distributors via the REG-13 reporting system.

An unauthorised variation means the medicinal product no longer complies with the marketing authorisation and must not be released onto the market. Any change—such as a change of manufacturer, pack size, or an update to the SmPC—requires approval. Variations are classified as IA, IB, and II depending on their significance.

Potential issues

How ARROWS helps (office@arws.cz)

Formally incorrect submission of documentation – leading to suspension of the proceedings and delays

ARROWS attorneys in Prague, in cooperation with regulatory experts, will review whether the documentation complies with the requirements of the Czech Act on Medicinal Products and the Czech Administrative Procedure Code.

Missing contractual arrangements for pharmacovigilance or distribution

We will prepare pharmacovigilance service agreements (SDEAs), distribution agreements, and provide legal oversight of compliance with GVP/GDP.

Penalties for failure to meet notification obligations

We will set up internal compliance processes for timely reporting of shortages, supplies, and adverse reactions under current legislation.

Pricing and reimbursement proceedings

We represent clients in administrative proceedings on price setting and reimbursement before SÚKL and in negotiations with health insurance companies.

Pricing, reimbursement, and negotiations with health insurance companies

For commercial success in the Czech Republic, it is crucial that the medicinal product is reimbursed from public health insurance. This is decided by SÚKL in administrative proceedings in which health insurance companies are also participants.

SÚKL assesses efficacy, safety, and cost-effectiveness compared to existing treatment. To obtain reimbursement—especially for highly innovative medicinal products—it is necessary to submit a pharmacoeconomic analysis.

In addition to officially set reimbursement, commercial negotiations are often conducted directly with health insurance companies regarding so-called Risk-Sharing Agreements (RSAs). ARROWS attorneys in Prague can help structure these agreements so that they comply with Czech competition law and the Czech Public Health Insurance Act.

Contact our experts

Related questions

1. How long does it take to obtain a marketing authorisation?
The standard assessment period is 210 days. Taking into account the time needed to prepare responses (clock-stop) and administrative steps before the decision is issued, in practice you should expect 12–18 months in the national procedure as well as under the DCP.

2. What are the most common reasons for refusal or delays?
Most commonly, these involve deficiencies in quality documentation (Module 3 CTD), insufficient evidence of bioequivalence (for generics), or formal errors in Czech texts (SmPC/PIL). Another risk is the absence of a GMP certificate for the manufacturer of the finished product or the active substance.

3. What if a new side effect appears during the authorisation process?
You are obliged to update the safety information in the submitted documentation. Concealing data is a serious breach and grounds for refusal of the marketing authorisation as well as potential criminal liability.

Risk area

How ARROWS helps (office@arws.cz)

Poorly chosen authorisation strategy

We analyse your portfolio and recommend the most suitable type of procedure (CP, DCP, MRP, national) with regard to time and costs.

Translations and localisation of texts (SmPC/PIL)

We will ensure a legal review of the texts to ensure they comply with decrees and SÚKL requirements (QRD templates).

Absence of a local representative

Although having a registered office in the Czech Republic is not mandatory, it is practical to have an authorised representative for service of documents and dealings with authorities.

Pharmacovigilance (fines and inspections)

We will help set up contractual relationships with pharmacovigilance service providers and ensure compliance.

Variation procedures and renewal of the marketing authorisation

We monitor deadlines for the “sunset clause” (revocation of the authorisation if the product is not placed on the market) and for renewal of the marketing authorisation (Renewal).

Cross-border dimension: When EU law applies

Pharmaceutical law is heavily harmonised by EU regulations. Key instruments include Regulation (EC) No 726/2004 for centralised procedures and Directive 2001/83/EC, which is transposed into the Czech Act on Medicinal Products.

Without legal personality in the EU, you cannot be a marketing authorisation holder. If your company is based outside the EU—for example in the USA, Switzerland, or the United Kingdom—you must, for authorisation purposes, have an established representative or a branch in an EU Member State.

Attorneys from ARROWS, a Prague-based law firm, have experience with cross-border mandates and will ensure that coordination between your headquarters outside the EU and the Czech authorities is handled in compliance with EU law and Czech specifics.

The most common mistakes companies make

  • Underestimating the time needed to prepare the submission: the eCTD dossier must be technically valid, otherwise SÚKL’s system will not accept the submission at all.
  • Ignoring Czech pricing rules: the price of a medicinal product in Germany is not automatically accepted in the Czech Republic, because SÚKL sets the maximum price based on .
  • Failure to ensure availability: an amendment to the Czech Act on Medicinal Products places emphasis on availability, and if you report an interruption of supplies late, you face high penalties.
  • Missing agreements: relationships between the marketing authorisation holder (MAH) and the distributor must be contractually governed, including technical quality and pharmacovigilance agreements.
  • Passive communication: SÚKL requires cooperation, and failure to respond to requests within the deadline leads to termination of the proceedings.

Final summary

Placing a medicinal product on the Czech market is a process that requires precise legal and technical preparation—from choosing the right procedure, preparing the dossier, and ensuring pharmacovigilance, to demanding negotiations on pricing and reimbursement.

Companies that apply foreign practices without knowledge of the local Czech Act on Medicinal Products and the Czech Public Health Insurance Act risk delays in market entry, fines in the millions of Czech crowns, or refusal of the marketing authorisation.

If you want to enter the Czech pharmaceutical market efficiently while minimizing risks, it is essential to work with specialists in pharmaceutical law. The team at ARROWS, a Prague-based law firm, has extensive experience with these processes and will guide you through the entire process. Contact us at office@arws.cz.

Frequently asked questions about how the market works in the Czech Republic

1. Who decides on medicine prices and reimbursement?
The maximum prices and the basic reimbursement from public health insurance are decided by SÚKL (the State Institute for Drug Control) in administrative proceedings. The final level of reimbursement and prescribing conditions are often the result of negotiations between the marketing authorisation holder and health insurance companies. No authority called “ŠUKL” exists in the Czech Republic—this is a common mistake; everything falls under SÚKL.

2. Do I have to establish a branch in the Czech Republic?
For the purposes of medicine registration (MAH), you do not need to have a branch in the Czech Republic if you are established in another EU country. However, you must be able to fulfil obligations in the Czech language, such as communication with SÚKL or handling quality defects, and ensure distribution through authorised entities.

3. What are the specifics for biological medicinal products?
Biological medicinal products, including biosimilars, are subject to mandatory centralised authorisation via the EMA. They cannot be authorised purely through the national route with SÚKL. Pharmacovigilance is stricter for these products and requires tracking of specific batches.

4. The medicinal product is authorised in Germany—can I start selling it in the Czech Republic immediately?
Not automatically. You must use the Mutual Recognition Procedure (MRP), where Germany will be the reference Member State and the Czech Republic will recognise its assessment. The process takes several months and requires approval of the Czech-language product information. An alternative is the so-called specific treatment programme, but this requires the consent of the Ministry of Health and SÚKL.

5. How high are the fines in this area?
The Act on Medicinal Products allows fines of up to CZK 20 million for serious offences. For breaches of advertising rules, a fine of up to CZK 5 million may be imposed. In the event of competition law infringements, sanctions may be even higher and are calculated as a percentage of turnover.

6. How long is the authorisation valid?
The authorisation is valid for 5 years. After 5 years, the holder must apply for renewal (Renewal). After the first renewal, the authorisation is usually valid for an indefinite period, unless SÚKL decides otherwise for pharmacovigilance reasons.

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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