Cinmed
20 years of Montenegro independence
Human medicines
Veterinary medicines
Medical devices
Inspectorate
Laboratory
Laboratorija

Clinical trials

Home » Human medicines » Clinical trials

 

In accordance with the Law on Medicinal Products, the Institute for Medicines and Medical Devices of Montenegro is responsible for issuing clinical trials authorizations, approving substantial modifications, registering non-interventional studies, trial inspecions, and monitoring the safety of investigational medicinal products.

Clinical trials in Montenegro are conducted in accordance with the Law on Medicinal Products, the Rulebook on Detailed Requirements and Documentation Necessary for the Approval and Conduct of Clinical Trials of Medicinal Products for Human Use, the Guideline for Good Clinical Practice (harmonized with ICH E6(R3)), and the Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11(R1)), while respecting the principles of medical ethics set out in the Declaration of Helsinki.

Medicinal products used in clinical trials must be manufactured in compliance with Good Manufacturing Practice (GMP) and must be labelled in accordance with the Rulebook. Where a medicinal product has a marketing authorization, it must also be labelled in accordance with the applicable regulations governing the labelling of medicinal products.

Within the Institute’s development policy, particular emphasis is placed on establishing the necessary infrastructure for conducting clinical trials in Montenegro, thereby increasing patients’ access to modern diagnostic methods and therapies. At the same time, the Institute devotes special attention to educating healthcare professionals and the general public in this field in order to reduce risks associated with the conduct of clinical trials in Montenegro.

General Information

A clinical study is any investigation involving human subjects conducted for the purpose of determining the safety and/or efficacy of medicinal products and intended to:

  • discover or verify the clinical, pharmacological, or other pharmacodynamic effects of one or more medicinal products;
  • identify any adverse reactions to one or more medicinal products; or
  • study the absorption, distribution, metabolism, and excretion of one or more medicinal products.

A clinical trial is a clinical study that meets any of the following conditions:

  • the assignment of subjects to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice in Montenegro or the concerned Member State of the European Union;
  • the decision to prescribe the investigational medicinal product is taken together with the decision to include the subject in the clinical study; or
  • diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

A low-intervention clinical trial is a clinical trial that fulfils all of the following conditions:

  • the investigational medicinal products, excluding placebos, are authorized medicinal products;
  • according to the clinical trial protocol:
  1. a) the investigational medicinal products are used in accordance with the terms of their marketing authorization; or
  2. b) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those medicinal products in any of the competent Member States of the European Union; and
  • the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared with normal clinical practice in any of the competent Member States of the European Union.

A non-interventional study is a clinical study that does not constitute a clinical trial.

Submission of Applications and Reports

Human medicines

Search register

Here you can search for medicines in our register

Sign up for

Newsletter