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Pharmaceutical /Medicine/Drug/OTC Registration in Slovakia

Pharmaceutical /Medicine/Drug/OTC registration in Slovakia

MOH- Ministry of Health of the Slovak Republic

MOH Website- https://www.health.gov.sk/ 

Regulatory Authority- The State Institute for Drug Control (SIDC)  

Regulatory Website- https://www.sukl.eu/sukl 

Local Authorized Representative Required- Yes

Classification

Prescription Medicine- A prescription medicine is a medicine that can only be made available to a patient on the written instruction of an authorized health professional. Examples of prescription medicines include blood pressure tablets, cancer medicine and strong painkillers.

OTC Medicine – Over the counter (OTC) medicines are those that can be sold directly to people without a prescription. OTC medicines treat a variety of illnesses and their symptoms including pain, coughs and colds, diarrhea, constipation, acne, and others.

Drug Approval Process

  • Decentralized Process

The Decentralized Procedure (DP) can be used for medications that are not yet approved in the European Union. Manufacturers of these medications may submit simultaneous permission applications to several EU member states. This process is governed by Directive 2004/27/EC. Any state that is only one member of the DP may decide to evaluate the application on its own.

  • Mutual Recognition Procedure

Market authorization issued in one EU member state is recognized in other EU member states under the Mutual Recognition Procedure (MRP). Only in cases where the manufacturer has already received market permission in an EU nation is MRP applicable. The Directive 2001/83/EC establishes the rules for market authorization through MRP. It is necessary to make sure that all MRP applications are comparable if they are sent to multiple EU nations. The nation reviewing the application is referred to as the Reference Member State, and it is its responsibility to inform the other relevant Member States of the application’s status.

  • Centralized Procedure

 Manufacturers can submit a single Market Authorization Application (MAA) to the EMA through the consolidated approach. Manufacturers who intend to sell their goods both inside the EU and in Iceland, Liechtenstein, and Norway—members of the European Economic Area (EEA)—will find the CP helpful. Following European Commission (EC) approval, producers can sell their products to healthcare professionals through a centralized mechanism under Regulation (EC) 726/2004.

  • National Procedure

The national procedure (NP) authorizes medications not covered by the centralized procedure or approved prior to the EMA’s formation. Manufacturers who want market authorization, particularly EU member states, can find it helpful. Applications in this procedure are examined by the relevant EU member state authorities. Every EU member state has its own national protocol.

Process

Preclinical Studies: Extensive preclinical studies are carried out to evaluate the safety and efficacy of new drugs before they are tried on humans. These investigations, which are typically carried out in lab environments, test the medication on animals, tissues, and cells to learn more about its pharmacological characteristics, possible toxicity, and impacts on biological systems.

Clinical Trials: A medicine moves on to clinical trials if preclinical research yields encouraging results and it is judged safe for use in human testing. Clinical trials are carried out in multiple stages:

Phase I: Small-scale research in fit participants to evaluate pharmacokinetics, dose, and safety.

Phase II: Extensive patient trials to gauge safety and effectiveness further.

Phase III: Extensive patient trials to verify effectiveness, track side effects, and evaluate the medication to existing treatments. 

Submission of Application: The pharmaceutical company applies for marketing authorization to the State Institute for Drug Control following the successful conclusion of clinical studies. Comprehensive information about the drug’s effectiveness, safety, and quality is included in this application, along with findings from preclinical and clinical research.

Assessment by ÚKL: The State Institute for Drug Control assesses the application for a marketing authorization to make sure the new medication satisfies safety, effectiveness, and quality requirements. In addition to reviews of the drug’s manufacturing procedures and labeling information, this examination may entail reviewing the data presented, including preclinical and clinical trial outcomes.

Approval Decision: The State Institute for Drug Control decides whether to approve or reject the application for marketing authorization based on the evaluation. If authorized, Slovakia will be able to market and distribute the novel medication for the authorized uses.

 Post Marketing Surveillance: After gaining clearance, post-marketing surveillance keeps an eye on the new drug’s efficacy and safety in actual clinical settings. This aids in the identification of any uncommon or persistent side effects that might not have been noticeable during clinical trials.

Pharmacovigilance

The only way to determine if a medication is safe and effective before it is approved for use is through the outcomes of clinical trials, in which participants are carefully chosen and intensively monitored in highly regulated environments. This indicates that a treatment has only been evaluated in a few carefully chosen patients for a short period of time at the time of authorization.

The medication may be used for a long term, with other medications, and on many patients after authorization. In certain situations, certain adverse effects might manifest. Hence, it is vital to oversee the safety of all medications during their administration in medical settings.

License Validity- 5 years

Registration Fee- 9 600,00 €