Additional Risk Minimisation Requirements in Slovakia

Ensuring that educational materials (EMs) are developed, approved, and distributed correctly is an essential part of pharmacovigilance activities in Slovakia. Over the years, the State Institute for Drug Control (Štátny ústav pre kontrolu liečiv, ŠÚKL) has established clear procedures to guide Marketing Authorization Holders through this process. Their goal is to highlight the most important risks associated with a drug and provide clear, structured information to reduce misuse or harm.  EM are not the same as marketing/promotional materials. Each educational material is specifically designed to minimize a specific risk/risk and focuses on a specific safety issue.

The EM is intended to provide clear and concise information describing the necessary measures to prevent/minimize the risks in question. EMs do not duplicate the SPC/PIL, but are intended to complement these documents in an appropriate manner.

As a local PV professional working closely with Slovak regulatory requirements, I would like to share practical insights into how additional risk minimisation measures are handled in Slovakia and what MAHs should keep in mind.

Regulatory Framework: Guideline MP 144/2023

ŠÚKL currently follows Guideline MP 144/2023 – Submission of Educational Materials, which outlines the submission, approval, and distribution requirements for EMs. This includes the process for joint educational materials covering the same active substance for different MAHs.
At the ŠÚKL Summer Conference in June 2025, the Authority announced that this guideline is under review, with upcoming changes expected to affect joint EMs -particularly the requirement to include a table listing all registered medicinal products. The updated version is still pending, so the industry is waiting to understand how the new process will evolve.

Purpose and Types of Educational Materials

Educational materials serve as additional risk minimisation tools, complementing  – but not duplicating – the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). They highlight key risks and provide practical guidance to ensure safe use.

Patient-Focused Materials

• Patient alert/reminder/information cards
• Guides for patients, parents, and caregivers
• Audio versions of written documents
• Instructional videos
• Patient diaries

Healthcare Professional – Focused Materials

• HCP/prescriber guides
• Controlled distribution or access program materials
• Checklists for adult and paediatric populations
• Pregnancy-prevention program materials

Each EM must address specific safety concerns tied to the product’s Risk Management Plan (RMP).

Submission Requirements in Slovakia

MAHs must submit EMs to ŠÚKL:

• In Slovak language (Word format)
• Along with the original version
• Together with the approved RMP and the distribution plan
• At least 3 months before product launch or before distributing updated EMs

Submissions are made via email to: [email protected].
Once approved, ŠÚKL publishes the EMs on its website.

Cooperation on Joint Educational Materials

When several MAHs market products with the same active substance, ŠÚKL requires the preparation of joint EMs. This ensures consistent messaging and reduces the burden on healthcare professionals, who receive unified information instead of multiple versions.

How Leadership Is Selected

ŠÚKL contacts all MAHs and requests them to agree on a leading company. If they do not reach agreement, ŠÚKL appoints one  –  this can be either the originator or a generic company.

Updating the Joint EM

The table listing all approved medicinal products (included in current versions of joint EMs) is updated:

• Four times per year: March 31, June 30, September 30, December 31
• The leading company must submit updates to ŠÚKL within 15 days

If a new generic product is approved, the MAH must request contact details of the leading company from ŠÚKL and ask to be added to the table.

Distribution of Educational Materials

Distribution follows the plan approved by ŠÚKL. Options include:

• Postal distribution of printed materials
• Email distribution
• Distribution through company representatives

Vendors typically carry out the distribution, while cost sharing arrangements are managed between MAHs without any involvement from ŠÚKL.

Special Situations

If a newly registered generic enters the market after joint EM distribution:

• The MAH must notify healthcare professionals via an informative, non-promotional letter
• ŠÚKL approval is not required for this letter
• The distribution details must be reported to ŠÚKL
• Re‑distribution of certain EMs (e.g., Patient Cards) may be necessary and should be coordinated with the leading company

If a company does not plan to market its product within 12 months, it does not need to participate in the initial joint distribution.

Summary

The Slovak system for EM submission and distribution is structured but can be complex  –  especially for materials involving special programs (e.g., pregnancy prevention, controlled access) or multiple MAHs. Close coordination is essential not only between MAHs but also with vendors and regulators.

From local experience, the most critical success factors include:

• Early preparation of EMs aligned with the RMP
• Clear internal planning for translations, reviews, and approvals
• Proactive communication for joint EM updates
• Careful documentation of all distribution steps
• Ensuring all materials remain non-promotional and strictly risk‑minimization oriented

Well‑managed collaboration ensures EMs reach their intended audience on time and effectively support the safe and appropriate use of medicinal products in Slovakia.