Marketing Authorisation and Market Entry for Medicinal Products in Czechia
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.
Key takeaways
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.
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.
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Potential issues |
How ARROWS helps (consultation@arws.cz) |
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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. |
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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. |
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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. |
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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.
Our specialists will help you
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Risk area |
How ARROWS helps (consultation@arws.cz) |
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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. |
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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). |
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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. |
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Pharmacovigilance (fines and inspections) |
We will help set up contractual relationships with pharmacovigilance service providers and ensure compliance. |
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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 consultation@arws.cz.
Read also:
- Key Healthcare, Pharma and Food Law Changes in the Czech Republic and EU in 2026
- Launching a Clinical Trial in the Czech Republic: Key Legal Requirements
- How to Structure Clinical Trials Agreements in Czechia Without Legal Headaches
- Dietary Supplements vs Medicinal Products in Czech Law: Key Compliance Steps
- Dietary supplement vs. medicine vs. novel food Comparison and differentiation
About the author
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 (consultation@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.