SÚKL Procedures for Marketing Authorisation Transfers, Variations and Renewals

Transfer of a medicinal product registration, changes in manufacturing or distribution, renewal of validity – all of these steps require the correct procedure with SÚKL (the Czech State Institute for Drug Control), otherwise you may face a fine of up to CZK 20 million. In this article, you will learn how to proceed with each type of change, what the most common mistakes are, and how to avoid unnecessary complications.

Quick summary

• Transfer of a marketing authorisation is an administrative process in which the new holder automatically steps into the rights and obligations of the previous holder in the case of a merger or demerger; for a standalone sale of a medicinal product, an application for transfer must be filed.
• Variations to a marketing authorisation are divided into types IA, IB and II depending on their impact on the quality and safety of the medicinal product—ranging from simple notifications to complex approval procedures.
• Common mistakes include missing documents, incorrect classification of the variation, or missed deadlines—any of which may be penalised by a significant fine or suspension of placing the product on the market in the Czech Republic.
• Specialists from ARROWS advokátní kancelář deal with these matters on a daily basis and will ensure that all steps are taken correctly and on time under Czech law.

Decision on the transfer of a medicinal product marketing authorisation – when and how to implement it

A transfer of a medicinal product marketing authorisation means that all rights and obligations arising from the marketing authorisation decision are transferred from the current holder to a new holder. In practice, you will most often encounter this when buying or selling a company, during group restructuring, or when selling a portfolio of medicinal products. Czech legislation distinguishes the process depending on whether the transfer occurs through universal succession or through a contractual transfer.

If your company undergoes a merger or takeover as a whole, the new owner automatically assumes the rights and obligations by operation of law. In such a case, you only notify SÚKL (the Czech State Institute for Drug Control) of this fact and provide evidence of the change in legal entity.

The situation is different when you are selling a specific medicinal product or a group of products as an isolated asset (asset deal). In that case, you must file a formal application to transfer the marketing authorisation to the new holder. The application must be submitted so that SÚKL can approve the transfer as of the effective date of the transfer agreement.

What the transfer application includes and how much it costs

The application is submitted electronically using the form prescribed by SÚKL and must include a number of annexes. These include, in particular, the transfer agreement, proof of the new holder’s registered office, and the new holder’s declaration of assumption of obligations. SÚKL has a statutory 30-day deadline to issue its decision, and it may request that the documentation be supplemented.

In practice, mistakes are often made in preparing the documentation—missing signatures, pharmacovigilance documents, or details of the person responsible for the marketing authorisation.

The costs consist of an administrative fee and reimbursement of SÚKL’s expenses. The administrative fee is CZK 2,000 for each application. Reimbursement of expenses for expert acts (code O-1) is CZK 3,000. The total cost of transferring one medicinal product is therefore CZK 5,000.

If you are selling a package of ten medicinal products, you must file a separate application for each—total administrative costs will then reach CZK 50,000.

Related questions – Transfer of a marketing authorisation

1. Do I have to wait for SÚKL’s approval before I can sell the medicinal product as the new holder?
Yes, the rights and obligations transfer only once the decision on the transfer becomes final and effective. As regards selling off stock in the original packaging, Czech law allows an overlap, meaning that the original packs may remain on the market for a certain period.

2. What if the new marketing authorisation holder is based outside the EU?
The law does not allow this. The holder of the marketing authorisation decision must have its residence or registered office in an EU Member State or in a country of the European Economic Area (EEA).

3. The current holder and I have agreed on the transfer—how long does it take?
The statutory deadline is 30 days. If the documentation is flawless, SÚKL issues its decision within this period. However, when preparing the contractual documentation and compiling the supporting materials, it is advisable to allow for a process lasting two to three months.

Variations to a marketing authorisation – what they are and why they differ

Not all variations are the same. The EU regulation classifies them into three basic categories depending on their impact on the safety, quality and efficacy of the medicinal product. This classification determines the procedural route: whether it is sufficient to notify the variation, or whether it is subject to approval.

Type IA variations – what you can do immediately

Type IA variations are administrative or simple changes with minimal impact on quality or safety. These include, for example, minor changes to packaging specifications or administrative changes of addresses. For standard type IA variations, the “do and tell” principle applies—you implement the change and then notify SÚKL afterwards.

However, there is a subgroup of IA _IN (immediate notification) variations that must be notified without delay after implementation. The difference is crucial, because late notification of an IA _IN variation constitutes an administrative offence.

Many companies assume that type IA variations are trivial. That is a mistake. They must be properly documented and validated. During an inspection, SÚKL checks whether the documentation matches the actual state of affairs.

Type IB variations – a notification that requires attention

Type IB variations are those that are not defined as type IA or type II. This is a “residual” category covering variations with a moderate impact, such as certain changes in the manufacturing process or changes to product information texts. For these variations, you submit a notification and wait.

A common mistake is miscalculating the deadlines. The time limit starts running only from confirmation of validation, not from the moment of submission to CESP. In practice, you should plan for a process of around 2 months including preparation and validation.

Type II variations – material changes requiring approval

Type II variations are those that may have a significant impact on the quality, safety or efficacy of the medicinal product. These include, for example, a change of indication, dosage, a substantial change in manufacturing, or the introduction of a new active substance manufacturer without a CEP certificate.

The standard assessment period for a type II variation is 60 days. Only after a positive opinion and decision is issued may you implement the change. For type II variations, the risk of refusal is the highest and they require precise expert documentation.

Related questions – Types of variations

1. How is the assessment period for a variation calculated?
The period starts running after the so-called validation of the application (a check of formal requirements), not on the day of submission. If SÚKL requests additional information, the period is suspended until the supporting documents are provided.

2. Do I always have to consult SÚKL if I am not sure about the classification of a variation?
It is not mandatory, but Czech law allows you to ask SÚKL for a recommendation on the classification of a variation that has not yet been classified. If you submit a variation under the wrong type, SÚKL will ask you to remedy it or will reject the application.

3. Can I continue selling the medicinal product normally while the variation is being assessed?
Yes. Until the variation is approved and implemented, you continue selling the medicinal product in its original form. The exception would be an Urgent Safety Restriction, which applies immediately.

How to submit an application correctly – technical and formal requirements

All applications for variations and transfers are submitted electronically, usually in the mandatory eCTD format via the CESP portal or via a data box (datová schránka) in the Czech Republic. The format is strict and subject to technical validation.

The basis is the electronic eAF (electronic Application Form), to which a cover letter and documentation structured into eCTD modules are attached.

The most common mistakes are an invalid technical format, an outdated version of the eAF form, or missing authorisation. An incorrectly paid administrative fee is also a frequent issue.

ARROWS, a Prague-based law firm, routinely provides a legal review of the application before submission. We ensure that the formal requirements are in order and that the content meets the requirements of Czech law. Feel free to contact us at office@arws.cz.

Most common mistakes and their consequences

The registration agenda with SÚKL (the Czech State Institute for Drug Control) requires precision. Mistakes mean not only delays but also financial penalties. Below we list the main areas where companies make errors.

Incorrect classification of a variation results in SÚKL returning the application for completion or rejecting it. In such a case, you lose time—often measured in months—and you must pay the fees again.

A common reason for suspension of proceedings is incomplete or incorrect documentation. If you fail to provide the required supplements within the set deadline, SÚKL will discontinue the proceedings.

For breaching the obligation to submit an application for a variation or to notify it, the Medicinal Products Act provides for a fine of up to CZK 500,000. This mainly concerns missed notification deadlines for Type IA _IN variations or annual notifications.

Placing a medicinal product on the market without an approved variation is a serious administrative offence. For placing a product on the market contrary to the marketing authorisation decision, a fine of up to CZK 20 million may be imposed.

If you do not update documentation in connection with new safety findings, you face penalties and the risk of suspension of the marketing authorisation. This insufficient monitoring of maintenance obligations does not pay off during inspections.

Risks in marketing authorisation variations and how to address them

Renewal of the marketing authorisation – keep an eye on the 9-month deadline

A marketing authorisation for a medicinal product is valid for a standard period of 5 years. You must apply for renewal no later than 9 months before the end of this period. Note: the deadline used to be 6 months, but Czech legislation has changed.

If you do not submit the application on time, the marketing authorisation expires by operation of law upon the end of its validity period. It is not possible to renew an authorisation that has already expired—you would have to go through the entire registration process again.

After the first renewal, the marketing authorisation is usually valid for an unlimited period. The application includes a consolidated version of the quality, safety and efficacy documentation incorporating all implemented variations and adverse reaction reports.

Obligations of the marketing authorisation holder – what must be reported and when

Once you have a marketing authorisation, a number of obligations arise. You must report the start, interruption and termination of placing the medicinal product on the market. Under the amendment to the Czech Medicinal Products Act effective from 2024, these obligations have been tightened.

Failure to ensure product availability or failure to submit a notification may result in a fine of up to CZK 20 million. Notifications of interruption or termination of supplies must be submitted sufficiently in advance, typically 2 months ahead.

Adverse reactions are reported to the EudraVigilance database. The marketing authorisation holder must have a pharmacovigilance system in place and a person responsible for pharmacovigilance (QPPV).

Related questions – Obligations after obtaining a marketing authorisation

1. What happens if I miss the deadline for reporting an interruption of supply?
You may face administrative proceedings and a fine of up to CZK 20 million, especially if the outage threatens the availability of care for patients. The new legislation places strong emphasis on reporting.

2. Do I have to report adverse reactions even if they are rare?
Yes. All suspected serious adverse reactions must be reported within 15 days; others must be reported at the intervals set by law.

3. What are the fees for maintaining a marketing authorisation?
In addition to fees for variations and renewal, an annual maintenance fee is payable upon request by SÚKL.

How to ensure protection – final recommendations

The medicinal product registration agenda with SÚKL is a highly formalised process that requires a combination of legal and technical expertise under Czech legislation. If you want to maintain your marketing authorisation without issues, it is essential to have a system in place to monitor deadlines (regulatory affairs) and legislative changes.

Experts from ARROWS, a Prague-based law firm, deal with this topic on a daily basis. We help not only with one-off tasks, but also provide long-term legal support and compliance services for both start-ups and multinational corporations.

This is not just administration—it is about protecting your investment in the development and marketing of the medicinal product. Prevention is always cheaper than dealing with penalties and sales interruptions.

Conclusion of the article

Marketing authorisation of a medicinal product is a dynamic process that does not end with the issuance of the decision. Transfers, variations and renewals are a standard part of it. Each of these steps has its own specifics and risks.

Our attorneys in Prague at ARROWS, a Prague-based law firm, will help you navigate complex Czech legislation safely and efficiently. If you do not want to risk fines or loss of the marketing authorisation, entrust your agenda to us. Simply contact us at office@arws.cz to arrange a consultation.

FAQ – Most common legal questions on medicinal product marketing authorisation and variations with SÚKL

1. What is the difference between a transfer of a marketing authorisation and the sale of a medicinal product as part of a company acquisition?
If you acquire the entire company, the marketing authorisations transfer automatically. If you are acquiring only an enterprise (business undertaking) or part of it that includes medicinal products, you must file an application for the transfer of the marketing authorisation, which is decided by SÚKL (the Czech State Institute for Drug Control). For the legal structuring of your M&A transaction in the Czech Republic, contact us at office@arws.cz.

2. What happens if I forget to renew the marketing authorisation?
If you do not submit the application no later than 9 months before the expiry date, the marketing authorisation will lapse on the day when 5 years have passed since it was granted. The medicinal product may then not be placed on the market in the Czech Republic.

3. Can I implement a Type II variation before SÚKL approves it?
No, Type II variations are subject to an approval procedure. Implementing the change before the approval decision becomes final and effective is a breach of Czech law and may result in a significant fine.

4. Preparing and filing variations costs me too much money – can’t I do it myself without a lawyer?
You can, but the risk of errors is high. The costs of re-filing and the loss of profit due to delays in placing the product on the market often exceed the cost of specialised legal support. ARROWS, a Prague-based law firm, can help streamline the process.

5. How do I check the validity of my marketing authorisation and deadlines?
The date of the marketing authorisation and its validity are stated in the marketing authorisation decision. You can also verify the details in the public medicines database on SÚKL’s website. We recommend keeping an internal calendar of regulatory obligations under Czech legislation.

6. What is the risk if I do not report medicine supply disruptions?
If you fail to comply with the obligation to report an interruption of supplies, you may face a fine of up to CZK 20 million. SÚKL has been monitoring these obligations very strictly recently in order to ensure the availability of medicinal products for patients in the Czech Republic.

Notice: The information contained in this article is of a general informational nature only and is intended for basic guidance on the topic. Although we strive for maximum accuracy, legal regulations and their interpretation evolve over time. To verify the current wording of the regulations and their application to your specific situation, it is therefore necessary to contact ARROWS directly. 

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