Montenegro Drug Product Registration

Content of EU Dossier

The European (EU) dossier is divided into four parts:

• 1st Part: Administrative Data:
  • Administrative information related to the medicinal product.
• 2nd Part: Pharmaceutical (Physico-Chemical, Biological, or Microbiological Information (Quality)):
  • Information pertaining to the pharmaceutical aspects, including Physico-chemical, biological, or microbiological data.
• 3rd Part: Pharmacological-Toxicological Documentation:
  • Documentation on either safety and residue tests of veterinary medicinal products or safety tests of immunological veterinary medicinal products.
• 4th Part: Documentation on Pre-clinical and Clinical Trials:
  • Documentation on either pre-clinical and clinical trials of efficiency for veterinary medicinal products or examination of efficiency for immunological veterinary medicinal products.

Submission Formats

• Module 1: Submission can be in either paper or electronic form.
• Modules 2, 3, 4, and 5: Submission must be in electronic form, with the possibility of submitting certain parts in paper form upon the Agency’s request.
• Parts of the EU dossier may be submitted either in paper or electronic form.

Application with Own Data

For an application with the applicant’s own data, the accompanying documentation on quality, safety, and efficacy of the medicinal product should include:

• Administrative data.
• Own data on pharmaceutical-chemical-biological testing of the medicinal product.
• Own data on pre-clinical (pharmacological-toxicological) testing of the medicinal product.
• Own data on clinical trials of the medicinal product.

Exceptionally, an application with its own data may contain data from the literature complementing and confirming the submitted data on its own testing (application with combined data).

Application with Bibliographical Data

An application for marketing authorization that includes bibliographical data on the safety and efficacy of a medicinal product should be accompanied by documentation containing the following:

• Administrative Data
• Own Data on Pharmaceutical-Chemical-Biological Testing
• Bibliographical Data on Pre-clinical (Pharmacological-Toxicological) Testing
• Bibliographical Data on Clinical Trial:
• Submission of bibliographical data obtained from published scientific literature or results of pre and post marketing studies related to clinical trials of the medicinal product.
• The use of bibliographical data is allowed only if there is proof that the active substance has been used as a medicinal product for at least ten years in Montenegro or other countries with similar standards for marketing authorization issuance.
• The literature should contain all necessary data from requested pharmacological-toxicological documentation or clinical documentation proving the safety and efficacy of the medicinal product.
• Bibliographical data should cover therapeutic indications for which the application has been submitted, including both positive and negative published data.
• In cases where certain bibliographical data are missing, the applicant shall provide an explanation in Module 2 of the CTD dossier, stating that a conclusion on the safety and efficacy of the medicinal product can still be drawn.

Application for Reference Medicinal Product

An application for marketing authorization referring to documentation of a reference medicinal product should be accompanied by documentation containing the following:

Administrative Data

Inclusion of administrative information related to the reference medicinal product.

References to Documentation

Inclusion of references to documentation about pharmaceutical-chemical-biological testing of the reference medicinal product, pre-clinical (pharmacological-toxicological) examination of the reference medicinal product, and clinical trials of the reference medicinal product.

Proof of Marketing Authorization Holder Agreement

Submission of proof that the marketing authorization holder of the reference medicinal product agrees with the reference to his documentation regarding the pharmaceutical-chemical-biological testing, pre-clinical i.e., pharmacological-toxicological examination, and clinical trial of the reference medicinal product.

Proof of Valid Marketing Authorization in Montenegro

• Submission of proof that the reference medicinal product possesses a valid marketing authorization in Montenegro.
• The reference medicinal product, in this context, has a different brand name from the medicinal product for which the application has been submitted.

Application for Marketing Authorisation for Biologically Similar Medicinal Product

An application for marketing authorization for a biologically similar medicinal product shall be submitted along with documentation containing the following:

• Administrative Data:
• Inclusion of administrative information pertaining to the medicinal product.
• Own Data on Pharmaceutical-Chemical-Biological Testing:
• Submission of data obtained from pharmaceutical, chemical, and biological testing of the medicinal product conducted by the applicant.
• Reference to Data on Pre-clinical (Pharmacological-Toxicological) Examination of the Reference Biological Medicinal Product:
• Inclusion of a reference to data on the pre-clinical examination of the reference biological medicinal product.
• Own Data on Pre-clinical Examination:
• Submission of own data, i.e., results of appropriate pre-clinical examination, including pharmacological-toxicological examination of the medicinal product, relating to differences from the reference biological medicinal product.
• Reference to Data on Clinical Trial of the Reference Biological Medicinal Product:
• Inclusion of a reference to data on the clinical trial of the reference biological medicinal product.
• Own Data on Clinical Trials:
• Submission of own data, i.e., results of appropriate clinical trials relating to differences from the reference biological medicinal product.

Own data from paragraph 1, indents 2 and 3 of this Article specifically refer to differences related to raw materials and the manufacturing process concerning the reference biological medicinal product, following the requirements of Annex I of Directive 2001/82/EC of the European Parliament and the Council of Europe. 

Application for Marketing Authorisation for Medicinal Product with Fixed Combination of Active Substances

An application for marketing authorization for a medicinal product with a fixed combination of active substances shall be submitted along with documentation containing the following:

• Administrative Data:
• Inclusion of administrative information related to the medicinal product.
• Own Data on Pharmaceutical-Chemical-Biological Testing:
• Submission of own data obtained from pharmaceutical, chemical, and biological testing of the medicinal product related to the fixed combination of active substances.
• Data on Pre-clinical (Pharmacological-Toxicological) Examination:
• Submission of data related to pre-clinical, i.e., pharmacological-toxicological examination of the medicinal product in relation to the fixed combination of active substances.
• Data on Clinical Trial:
• Submission of data related to the clinical trial of the medicinal product concerning the fixed combination of active substances.

Generic Drugs

Registration fees:  Full registration: 1,000- 4,000 EUR

                                      Renewal: 500-2,000 EUR

Global Marketing Authorisation and Generic Medicinal Products: A Comprehensive Overview

Global marketing authorisation is a regulatory framework that streamlines the approval process for medicinal products, creating a unified approach for authorisations granted in Montenegro and European Union (EU) countries. This article explores the key aspects of global marketing authorisation, with a focus on generic medicinal products and the associated protection periods.

1. Definition of Global Marketing Authorisation: Global marketing authorisation pertains to the approval of a reference medicinal product in Montenegro or EU countries. Subsequent authorisations for the same product, considering amendments related to strength, pharmaceutical form, route of administration, packaging, and additional animal species for veterinary medicinal products, are treated as part of the same global marketing authorisation.
2. Exemptions for Generic Medicinal Products:

• An applicant seeking authorisation for a generic medicinal product may be exempt from providing results of non-clinical tests and clinical trials, including safety and residue results.
• This exemption applies if the generic product is based on a reference medicinal product that has been authorised in Montenegro, an EU Member State, or through the centralised marketing authorisation procedure for at least eight years since the issuance of the global marketing authorisation for the reference product.

3. Bioavailability Studies Exemption:

Bioavailability studies need not be submitted by the applicant for a generic medicinal product if they can demonstrate compliance with relevant criteria outlined in the guidelines of the European Commission and the European Medicines Agency (EMA) for bioequivalence studies.

4. Protection Period for Generic Medicinal Products:

• The marketing authorisation holder cannot market the generic medicinal product until ten years have passed from the initial authorisation of the reference product.
• This 10-year period can be extended for one additional year for medicinal products for human use if, within the first eight years, the marketing authorisation holder obtains authorisation for new therapeutic indications deemed to bring significant clinical benefit during scientific evaluation.

5. Calculation of Protection Periods:

Protection periods, as outlined in paragraphs 2, 4, and 5, are calculated from the date of the initial authorisation within the global marketing authorisation.

6. Disclosure Requirements:

In cases exempting generic products from providing certain data, the applicant must indicate the EU Member State where the reference medicinal product is or has been authorised, along with the date of the initial authorisation.

7. Confirmation Process for Montenegro-Authorised Products:

If the reference medicinal product is or has been authorised in Montenegro, and if requested by the competent authority of an EU Member State, the Institute has 30 days to provide confirmation along with data on the full composition of the reference product and additional required information.

Application for Marketing Authorisation for Generic Medicinal Product

An application for marketing authorization for a generic medicinal product shall be accompanied by documentation containing:

• Administrative Data
• Own Data on Pharmaceutical-Chemical-Biological Testing
• Reference to Data on Pre-clinical (Pharmacological-Toxicological)
• Examination of the Reference Medicinal Product
• Reference to Data on Clinical Trial of the Reference Medicinal Product
• Proof of Essential Similarity:
• Submission of proof demonstrating the essential similarity between the reference medicinal product and the medicinal product for which the application for marketing authorization is being submitted.
• Proof of Marketed Duration:
• Submission of proof that the reference medicinal product has been marketed for at least eight years in Montenegro or in other countries with equivalent professional requirements for obtaining marketing authorization for a medicinal product.
• Proof of Safety and/or Efficacy:
• Submission of proof demonstrating that there are no significant differences in terms of safety and/or efficacy between the generic medicinal product and the reference medicinal product, or confirmation of equal safety and/or efficacy if the active substance in the generic medicinal product differs from the active substance in the reference medicinal product (e.g., salt, ester, ether, isomer, mixture of isomers, complex, or derivative).

Application for Marketing Authorisation for Generic Medicinal Product with Combined Data

An application for marketing authorization for a generic medicinal product with combined data shall be submitted along with documentation on safety and efficacy containing the following:

• Administrative Data
• Own Data on Pharmaceutical-Chemical-Biological Testing
• Reference to Data on Pre-clinical Examination of the Reference Medicinal Product
• Own Data on Safety
• Reference to Data on Clinical Trial of the Reference Medicinal Product
• Own Data on Clinical Trials