Medicinal Product Registration in the Czech Republic: Process, Timeline and Risks

23.3.2026 | ARROWS law firm

Registration of a medicinal product is one of the most demanding and most important processes in the pharmaceutical industry. To show you everything you need to meet for your medicinal product to legally reach patients, you will find information on the entire registration process. In this article, you will learn the specific steps, deadlines, and risks you may face if something goes wrong.

Three main registration procedures in the Czech Republic
Timeline: from submission to decision
Registration dossier in detail
What happens after registration is approved? Your obligations
Risk and issues table – what to expect
Specifics for different types of medicinal products
Reviews and inspections – what to expect
What costs you should plan for

Quick summary

In practice, registration takes 9 to 18 months depending on the type of procedure (national, decentralised, centralised), the quality of the submitted dossier, and the number of procedure pauses ("clock-stops").
The most common registration mistakes involve incomplete documentation (missing modules), an incorrect eCTD format, and formal defects in powers of attorney or administrative details, which lead to the procedure being paused.
After registration is granted, your obligations do not end: you must monitor the medicinal product’s safety (pharmacovigilance), report adverse reactions, renew the registration on a regular basis, and pay maintenance fees.

What you need to know about medicinal product registration in the Czech Republic

Medicinal product registration is an administrative procedure that every mass-produced medicinal product must undergo before it can be placed on the market. The State Institute for Drug Control (SÚKL) has a clear mandate to grant a marketing authorisation only to medicinal products that meet all criteria for quality, safety, and efficacy. This is not a mere formality—it is a key safety mechanism protecting patients.

In the Czech Republic, there are essentially three ways to register a medicinal product. Each route has its own specific requirements, deadlines, and costs. Choosing the right route is the first step, but it involves more pitfalls than it may seem.

Three main registration procedures in the Czech Republic

1. National registration – for the local market

If you want to register a medicinal product only in the Czech Republic and the product has not yet been registered in another EU Member State, you will choose the national procedure. This may seem like the simplest route, but be careful—it can become a strategic trap for companies with future European ambitions.

If you later want to expand sales to other EU countries, the process will need to be converted into the mutual recognition procedure (MRP), which brings additional administration. The application is submitted to the State Institute for Drug Control via the CESP portal in the mandatory electronic eCTD format.

You must pay an administrative fee and, in particular, reimbursement of costs for expert activities, which for a new full marketing authorisation is in the hundreds of thousands of Czech crowns.

The current SÚKL fee schedule sets amounts exceeding CZK 200,000 depending on the type of application. The total time to obtain a decision is typically divided into a validation phase (30 days) and an assessment of the dossier (210 days). This timeframe does not include the period during which the applicant supplements missing documents. If you miss the renewal deadline, the marketing authorisation lapses and you would have to start from scratch.

2. Mutual recognition and decentralised procedures

If you want to register a medicinal product in multiple EU Member States, you have two options that are very common among ARROWS clients: the decentralised procedure (DCP) or the mutual recognition procedure (MRP). The main difference between the two is whether the medicine is already authorised somewhere (MRP) or not (DCP).

The attorneys from ARROWS, a Prague-based law firm, have experience coordinating these procedures and know how to minimise the risk of confrontations already at the preparatory stage. In this case, the timeline is strictly set by European regulations. After validation, the assessment takes place and should be completed within 210 days (for DCP), followed by the national phase of issuing the decision.

3. Centralised procedure – mandatory for certain medicinal products

The centralised procedure run by the European Medicines Agency (EMA) is mandatory for medicinal products of a certain nature. These include, for example, biotechnology-derived medicinal products, medicines for rare diseases, and new active substances for the treatment of oncology indications, HIV, or diabetes.

The risk here is not only the length of the procedure, but also that the EMA requires highly robust data. Regulatory requirements are strict, and once the EMA issues a negative opinion, it is very difficult to reverse the situation.

Documentation you must prepare

The registration dossier is a substantial body of texts, studies, and data. Everything must be submitted in the standardised eCTD format and via the electronic application form (eAF), filed through the CESP portal.

The dossier contains five core modules:

Administrative information (Module 1)
Summaries (Module 2)
Quality (Module 3 – chemical, pharmaceutical, and biological information)
Non-clinical studies (Module 4 – toxicology and pharmacology)
Clinical studies (Module 5 – efficacy and safety in humans)

A common mistake is also the absence of, or formal defects in, the power of attorney or authorisation for the person responsible for pharmacovigilance (QPPV). Under the Czech Act on Medicinal Products, the applicant must be established in an EU/EEA Member State. The State Institute for Drug Control will identify deficiencies during validation and will ask you to supplement them, which delays the process.

Which data differ depending on the type of medicinal product?

You do not have to submit identical documentation for all types of medicinal products. If you are registering an originator medicine (a new medicine with a new active substance), you must provide the results of all phases of preclinical and clinical evaluation. The result is that there is no need to conduct extensive clinical safety and efficacy studies, which significantly reduces costs.

However, if you are registering a generic, it is sufficient to demonstrate bioequivalence. This means that the medicinal product behaves in the body comparably to the originator product. There is also the option to register medicines whose active substance has a well-established medicinal use (WEU).

Timeline: from submission to decision

How long does registration take in practice? - statutory time limits are one thing, reality is another. Under the national procedure, SÚKL typically has 30 days for validation and then 210 days for the scientific assessment. In practice, the process is extended by so-called "clock-stops". If SÚKL raises questions or requests additional documentation, the assessment clock stops and resumes only after the answers are delivered.

The applicant usually has 3 to 6 months to respond, and an extension may be requested. If the applicant does not respond in time or responds inadequately, SÚKL may discontinue the proceedings or reject the application. Our experience enables us to help with preparation so that the dossier is of the highest possible quality and the number of pauses is minimised.

How is the time limit calculated? - this is where a hidden pitfall lies, because the time limit for the scientific assessment does not start running on the day the application is sent. It starts running only on the day following the day on which the application was validated (recognized as formally complete). In practice, expect that the validation phase alone may take longer than 30 days if there are errors in the application. The total real time from filing to the issuance of a decision in the national procedure therefore commonly reaches 12 to 18 months.

Registration dossier in detail

Module 1: Administrative – what belongs here

This includes the application form (eAF), details of the applicant, the manufacturer, the future marketing authorisation holder, and details of the person responsible for pharmacovigilance. It sounds simple, but in practice the lawyers at ARROWS, a Prague-based law firm, often see errors in the Summary of Product Characteristics and the Package Leaflet.

These texts must be fully compliant with the QRD templates and current legislative requirements. If the texts are not clear (user testing of the PIL) or do not correspond to the scientific documentation, the regulator will return them for revision.

Module 2: Summaries and overviews

Module 2 is the main guide to the entire registration dossier – it is the first part that assessors at the regulatory authority read, and at the same time the integrating element of the entire documentation. It is based on the international ICH M4 standard and is shared across all regions (the EU, the USA, Japan and other ICH signatories).

Module 3: Quality – how the medicinal product is manufactured and controlled

Here you must describe the chemical, pharmaceutical and biological properties. You must demonstrate that both the manufacturer of the finished product and the manufacturer of the active substance operate in compliance with Good Manufacturing Practice (GMP). The main evidence is a GMP certificate and, in the case of the active substance, often a so-called CEP or complete documentation within the ASMF. The regulator reviews the entire supply chain.

Modules 4 and 5: Safety and efficacy

Module 4 contains data from non-clinical (toxicological) studies. Module 5 then contains data from clinical studies. For generics, this is usually only a bioequivalence study; for full applications, it involves comprehensive data from phases I to III of clinical trials.

What happens after the registration is approved? Your obligations

The marketing authorisation decision is valid for 5 years. After the first renewal, the authorisation is usually valid for an unlimited period, unless SÚKL decides otherwise for pharmacovigilance reasons. You must apply for renewal no later than 9 months before the expiry date. If you do not submit the application in time, the authorisation expires by operation of law upon the end of its validity period.

Reinstatement of an authorisation that has already expired is not possible by way of renewal and you would have to submit an entirely new application. For renewal, you must submit a consolidated version of the quality, safety and efficacy documentation.

Pharmacovigilance – reporting adverse reactions

The marketing authorisation holder must have permanently and continuously available a person responsible for pharmacovigilance (QPPV) residing in the EU. You must maintain and manage the Pharmacovigilance System Master File (PSMF).

All suspected serious adverse reactions must be reported to the EudraVigilance database within 15 days from the moment you become aware of them. Other adverse reactions must be reported within 90 days. Breach of pharmacovigilance obligations is an administrative offence, for which fines in the millions of Czech crowns may be imposed.

Variations to the marketing authorisation – and their classification

After authorisation, changes will occur, such as a change of manufacturer, a change in pack size, or amendments to the texts. Each change is subject to SÚKL approval or notification.

There are variations of the following types:

IA and IA/IN (minor administrative variation),
IB (standard minor variation),
II (major variation).

Incorrect classification of a variation leads to rejection of the variation and the need to submit it again correctly, including payment of a new fee.

Table of risks and issues – what to expect

Risks and sanctions	How ARROWS helps (office@arws.cz)
Placing on the market without an approved variation: If you make a major change in manufacturing without approval (a Type II variation) and place the medicinal product on the market, you face a fine of up to CZK 20 million.	Legal and regulatory advice: ARROWS will ensure correct classification of variations and prepare the submission in compliance with the Variations Regulation.
Incomplete documentation at registration: Lack of a valid eCTD, missing PSMF, or an incorrect power of attorney leads to suspension of the proceedings and increased costs.	Preparation and review of documentation: ARROWS, in cooperation with regulatory experts, will ensure the formal correctness of the submission.
Missing the renewal deadline: If the renewal application is not submitted 9 months before the end of validity, the authorisation will irreversibly expire.	Monitoring and management of deadlines: ARROWS monitors the deadlines of your authorisations and will prompt you in time to start the steps for renewal.
Breach of distribution rules: Failure to comply with the obligation to ensure availability of the medicinal product (amendment to the Act on Medicinal Products) may lead to high sanctions.	Compliance advice: ARROWS will help you set up contractual relationships and processes so that you meet the statutory availability requirements.

Specifics for different types of medicinal products

1. Generics and similar products

Generic registration is procedurally simpler thanks to the absence of proprietary toxicology and clinical studies. However, for market entry it is crucial not only to obtain the marketing authorisation, but also to secure reimbursement from public health insurance. As a rule, the first generic entering the market must offer a significantly lower price than the originator in order to meet the conditions for accelerated entry into the reimbursement system.

2. Biosimilars – biologically similar medicinal products

Biosimilars are not generics in the true sense of the word, because biological medicinal products are complex molecules and an exact copy cannot be made. The regulator requires evidence of biosimilarity, i.e., comprehensive comparative quality studies, preclinical and clinical studies. Most biosimilars are authorised via the centralised procedure through the EMA.

3. Medicinal products for rare diseases (orphan drugs)

If your medicinal product is intended for the diagnosis, prevention, or treatment of a life-threatening condition affecting no more than 5 in 10,000 people in the EU, you can apply for orphan drug status. This status provides 10 years of market exclusivity, reduced EMA fees, and expert assistance in preparing study protocols.

Audits and inspections – what to expect

SÚKL (the Czech State Institute for Drug Control) carries out both regular and targeted inspections, which may concern good manufacturing practice, good distribution practice, or pharmacovigilance. Inspectors verify whether reality corresponds to the registration documentation and statutory requirements. For failure to comply with obligations related to supplying medicinal products to the market or for unauthorised export, distributors and marketing authorisation holders may face fines in the millions of Czech crowns.

If SÚKL contacts you with a notice of inspection, it is sensible to have legal support. In recent years, inspections have also focused on safety features and on ensuring the availability of medicinal products for Czech patients. ARROWS’ Prague-based attorneys regularly represent clients during inspections and in administrative proceedings.

What costs you should plan for

Registration costs consist of an administrative fee and, in particular, reimbursement of expenses for SÚKL’s expert acts. According to the schedule of fees, reimbursement for a new national marketing authorisation is in the hundreds of thousands of Czech crowns, depending on the type of medicinal product and the legal basis. For generics, the amount is lower, but still significant.

In addition to SÚKL fees, you should budget for the preparation of the eCTD, translations of texts, and above all the costs of development and studies themselves. After authorisation, a so-called annual maintenance fee must be paid for each variant of the medicinal product.

Table of risks and issues – practical situations

Risks and sanctions	How ARROWS helps (office@arws.cz)
Misunderstanding the differences between procedures: You choose a national authorisation even though you plan to expand, which will make entry into other EU markets more expensive and complicated in the future.	Strategic advice: ARROWS will help you choose the optimal procedure (MRP/DCP/Centralised) according to your business plan.
SÚKL inspections identify non-compliance: An inspection finds that the pharmacovigilance system (PSMF) is not up to date or that supplier audits are missing.	Preparation for inspections: ARROWS will guide you through audit preparation and represent you in dealings with inspectors.
Anti-counterfeiting measure (FMD): Failure to comply with the obligation to include safety features on the packaging will prevent the medicine from being dispensed in a pharmacy.	Compliance: ARROWS will provide a legal review of contracts with code repository providers and ensure compliance with Regulation 2016/161.
Sanctions for supply disruptions: If you do not comply with the new rules for reporting supply interruptions and ensuring availability, you face high fines.	Availability advisory: We will help set up reporting processes so that you avoid sanctions under the amendment to the Czech Act on Pharmaceuticals.

Practical tips – how to avoid the most common mistakes

Mistake No. 1: Submitting incomplete documentation. SÚKL strictly requires the eCTD format and all formal requirements. Validation is a sieve—anything that does not pass is returned or rejected. Do not cut corners on expert preparation of the dossier. Deadlines for renewal of the marketing authorisation or for reporting variations are unforgiving.

Mistake No. 2: Underestimating pharmacovigilance. A QPPV is not just a name on paper; it must be a qualified person who is genuinely reachable (24/7) and fulfils their obligations. Failure here has a direct impact on patient safety and carries the highest risk of sanctions. Retrospective changes are expensive.

Conclusion

Marketing authorisation of a medicinal product is a complex administrative procedure that requires precision. You must understand that it is more than just paying a fee and sending documents. It is an intersection of law, medicine, and pharmacy governed by strict Czech and European regulations. A missed renewal deadline, an incorrectly classified variation, or pharmacovigilance errors can lead to fines in the millions of Czech crowns.

The lawyers at ARROWS, a Prague-based law firm, have experience in the regulation of medicinal products and medical devices. We know what documents SÚKL requires and how to prevent procedural mistakes. In addition, we are insured for damages up to CZK 400 million, so your investment is protected. Simply contact ARROWS advokátní kancelář at office@arws.cz and we will help ensure that your marketing authorisation process is compliant with Czech law.

FAQ – Most common legal questions on medicinal product authorisation in the Czech Republic

1. How long does it take to obtain a marketing authorisation in the Czech Republic?
The standard assessment time is 210 days, but when you add validation time and clock-stops for supplementing documentation, you should realistically expect 12–18 months for the national procedure. If you need to accelerate market entry, contact us for a strategy consultation.

2. What is the difference between national and centralised authorisation?
A national marketing authorisation (issued by SÚKL) is valid only in the Czech Republic. A centralised marketing authorisation (issued by the European Commission based on the EMA’s assessment) is valid in all EU Member States at once. The centralised procedure is mandatory for biotechnological medicinal products, orphan drugs, and certain other innovative medicines.

3. What happens if I miss the deadline for renewal of the marketing authorisation?
If you do not submit the application no later than 9 months before expiry, the marketing authorisation will lapse upon the end of the period for which it was granted. The product becomes unauthorised and may no longer be placed on the market. Renewal is not possible; you must submit a new marketing authorisation application.

4. Do I have to report all adverse effects?
The marketing authorisation holder is obliged to record all suspected adverse reactions. Serious cases must be reported to the EudraVigilance database within 15 days and non-serious cases within 90 days (for cases occurring in the EEA).

5. What are the registration fees?
The administrative fee is CZK 2,000, but the key cost is reimbursement of SÚKL’s expenses, which typically amounts to hundreds of thousands of Czech crowns (approx. CZK 200,000–450,000 depending on the type of application). You also pay annual maintenance fees. For an accurate cost calculation, please contact us.

Notice: The information contained in this article is of a general informational nature only and is intended to provide basic guidance on the matter based on the legal status as of 2026. Although we take utmost care to ensure accuracy, legal regulations and their interpretation evolve over time. We are ARROWS advokátní kancelář, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client protection we maintain professional liability insurance 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 advokátní kancelář directly (office@arws.cz). We accept no liability for any damages arising from the independent use of the information in this article without prior individual legal consultation.

Read also: