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Slovenia Drug Product Registration

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Slovenia Drug Product Registration

Slovenia Drug Product Registration

MOH

Ministry of Health of the Republic of Slovenia

MOH Website 

https://www.gov.si/e

Regulatory Authority 

The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Regulatory Website

https://www.jazmp.si/en/human-medicines/

Local Authorized Representative Required 

Yes

Drug Approval Process

Legally, pharmaceuticals cannot be placed on the market unless they have received marketing authorization. A natural person or legal business in the EEA must apply before a marketing authorization can be granted.

Obtaining a marketing authorization can be done through a nationwide procedure.

1. Mutual recognition process;

2. A decentralized

3. Centralized  process.

The following five modules must be included in the common technical document (CTD) that is used to apply for a marketing authorization:

Module 1: administrative data containing information on the medication (labeling, patient information leaflets, and summary of product characteristics, or SmPC); –

Module 2: condensed data regarding the medication’s efficacy, safety, and quality;

Module 3: comprises data pertaining to quality;

Module 4: concerns safety;

Module 5: concerns the medical product’s efficacy.

Annex I to Directive 2001/83/EC, as amended, provides a detailed description of the form, content, and features of the modules for certain applications and medicinal goods.

  • 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 to get market authorization, in particular 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 laboratory and animal studies are carried out to evaluate a drug’s safety and effectiveness before to trying it on humans.

Clinical Trials 

A medicine is put through human clinical trials if preclinical research yields encouraging findings. There are various stages to these trials:

Phase I: Small-scale research to evaluate dose and safety in healthy participants.

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

Phase III: Extensive patient trials to verify effectiveness, track side effects, and assess how well the medication works in comparison to current therapies.

Application Submission 

Following the successful conclusion of clinical trials, the pharmaceutical company applies to JAZMP for marketing permission.

JAZMP Evaluation  

The application and the results from clinical and preclinical investigations to see if the medication satisfies quality, safety, and efficacy requirements. A group of specialists comprising statisticians, doctors, and pharmacologists may be involved in this assessment.

Approval Decision

JAZMP decides whether to accept or deny the marketing authorization application considering the evaluation. The medication may be sold and delivered in Slovenia if it is approved.

Post-Marketing Surveillance

JAZMP keeps an eye on the efficacy and safety of medications even after they have been approved. This entails gathering and examining information on negative reactions and additional safety issues.

Registration Timeline

  • National procedure: 210 days
  • Mutual recognition procedure: 90 days + 30 days for the review of translations
  • Decentralized procedure: 210 says + 30 days for the review of translations
  • Centralized procedure: 210 days + the time required by the decision process of the European Commission.

Pharmacovigilance

Monitoring the Safety of Medicinal Products

Pharmacovigilance, the term for the monitoring of pharmaceutical products’ safety throughout use, encompasses all activities pertaining to the identification, evaluation, comprehension, and avoidance of adverse drug responses and other potential issues associated with pharmaceutical products. 

To make sure that the balance between benefit and risk for patients taking the medication stays positive, it is crucial to monitor and evaluate the risks and benefits of the medical product.

Pharmacovigilance-related activities include

  • Gathering and evaluating reports on adverse drug reactions, evaluations of the benefit-risk ratio of pharmaceuticals, and assessments of additional data pertaining to the safety of pharmaceuticals (research, data published in scientific publications, etc.)
  • Identifying safety indicators, evaluating risks that have been found, and establishing and putting into practice safety procedures for the use of pharmaceuticals
  • Evaluation of safety data provided by the holder of the marketing authorization in the Periodic Safety Update Reports (PSUR) evaluation of risk management plans, including risk minimization strategies activities in the global pharmacovigilance system, such as reporting to the World Health Organization’s Vigi Base database and the European database of adverse drug reactions Surveillance as part of the WHO Programme for International Drug monitoring.
  • Encouraging medical practitioners and patients to report adverse medication reactions by carrying out pharmacovigilance checks of marketing authorization holders
  • Educating the public and healthcare professionals on the pharmacovigilance of pharmaceuticals.

License validity 

      5 years

Registration fee

      9 600,00.€

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