Application for marketing authorization shall be submitted to the Institute. According to the Law on medicinal products, an applicant for marketing authorization may be may be a natural or legal person established in Montenegro, and from the date of Montenegro accession to the European Union, also a natural or legal person established in the European Union.

Documentation required for issuance of marketing authorization shall, in line with the Rulebook on more detailed conditions for issuance of marketing authorisation for a medicinal product  be submitted in a CTD form – Common Technical Document).

After receiving the application, the formal assessment of the documentation is performed, i.e. the determination of completeness of the application. The Institute shall assess whether the application for marketing authorisation is valid within 30 days from the date of receipt of the application. If the application is not complete, the Institute shall notify the applicant and set a deadline for correcting the deficiencies, which may not exceed 30 days. In justified cases and at the request of the applicant, the Institute may extend the deadline for correcting deficiencies by an additional 30 days.

After determining that the application is complete, the Institute shall inform the applicant on it and expert-scientific assessment of documentation on quality, safety and efficacy begins. Within the marketing authorisation issuance procedure, the Institute creates a report on the documentation assessment with the opinion on results of non-clinical and clinical testing of the medicine, on RMP and pharmacovigilance system. If necessary, in this stage also the applicant is required to submit additional documentation, or to provide additional explanations (clock stops).

When dealing with the assessment of pharmaceutical and pharmacological-toxicological and clinical documentation on quality, safety and efficacy of a medicine, experts employed in the Institute closely cooperate with external experts from Montenegro and the region, while Advisory Body – Commission for placing medicines on the market, gives expert opinion on the issuance of marketing authorization for a medicine. In addition to laws and rulebooks applicable in Montenegro, experts, when assessing, also apply European and international regulation, mainly guidelines for the assessment of quality, safety and efficacy of the European Medicines Agency and ICH – International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).

Institute shall issue marketing authorization, or bring the decision rejecting the application for the issuance of marketing authorization based on the assessment of the documentation on quality, safety and efficacy of the medicine.

The procedures and deadlines for issuing a marketing authorisation for a medicinal product are in line with EU directives. The length of the documentation assessment procedure may vary depending on the type of medicinal product and the quality of the initially submitted documentation, i.e. whether and to what extent the documentation needs to be supplemented as part of the assessment procedure.

The Institute issues a national marketing authorisation valid on the territory of Montenegro. Marketing authorisations for medicinal products issued in other countries do not have automatic validity on the territory of Montenegro, but each medicinal product must undergo the marketing authorisation procedure at the Institute. However, if the medicinal product is already registered in the EU, in accordance with the Law on Medicinal Products, the evaluation procedure may be shorter with the acceptance of relevant expert opinions.

Integral parts of marketing authorization are Summary of Product Characteristics (SmPC) which is intended for expert public, i.e. healthcare professionals and Package Leaflet (PL), intended for a patient, i.e. user a of a medicine and is in line with Summary of Product Characteristics.

Information on medicines authorized for marketing and approved SmPCs and PLs may be found in the section Register of medicines for human use.

In accordance with Article 25 of the Law on medicines, the Institute for medicines and medical devices shall establish the Commission for marketing authorization of medicines as an advisory body.

The Commission is a professional body that carries out tasks related to the granting and renewal of marketing authorizations for medicines, as well as the approval of variations to marketing authorizations.

Members of the Commission may be permanent members or ad hoc members invited for specific types of medicines. The Commission is professional, independent and autonomous within the scope of its work.

The detailed manner of operation of the Commission is regulated by its Rules of Procedure

In accordance with the Article 64 of the Law on Medicinal Products, after the marketing authorisation has been granted, the marketing authorisation holder shall notify the Institute of the date on which the medicinal product is placed on the market in Montenegro, for each pharmaceutical form and pack size and, within 15 days from the date of placing the product on the market, using the notification form published on the Institute’s official website.

After obtaining marketing authorisation, marketing authorisation holder is obliged to follow the latest scientific-technical developments and data on safety and efficacy of the medicine that may affect the benefit-risk ratio of its use and to report to the Institute throughout the life cycle of the medicine all changes to approved documentation, information on the medicine and conditions of issued marketing authorisation. 

Application for notification/approval of the variation shall be submitted to the Institute on the form available here (updated 16.2.2026.).

Variations are classified in accordance with the Regulation 1234/2008/EC and Guidelines 2013/C 223/01 on variations of European Union.

Along with the application for amendments approval, marketing authorisation holder shall submit data and documentation pertaining to the variation which provides sufficient data for its assessment, depending on the type of amendment to marketing authorisation.

Application for renewal of marketing authorization for a medicine shall be submitted to the Institute not later than nine months before marketing authorisation ceases to be valid, in line with the Instruction –  Manner of submitting application and documentation for the renewal of marketing authorisation for medicines for human use  on the application form for renewal of marketing authorization for a medicine that is available here.  

Marketing authorisation may be renewed for a further period of next five years based on reassessment of the medicine’s benefit-risk ratio. If, based on pharmacovigilance data within a period of five years from the date of issuance, or renewal of marketing authorisation, the Institute determines that the medicine that obtained marketing authorisation is safe, it shall issue marketing authorisation for an indefinite period.

Application for transfer of marketing authorization to the other marketing authorization holder shall be submitted to the Institute in line with the Instruction – Manner of submission of application and documentation for the transfer of marketing authorisation to the other marketing authorisation holder (updated 17.2.2023.) on the form available here.

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In accordance with Article 83 of the Law on Medicinal Products,

The Institute shall, without delay, publish on its website information on granted marketing authorisations together with the approved summaries of product characteristics, package leaflets and specific obligations or conditions under which conditional marketing authorisations have been granted, including the deadlines for the fulfilment of such obligations or conditions, as well as information on marketing authorisations that have ceased to be valid.

Register contains information about all medicines authorized for marketing, and also about medicines whose marketing authorization ceased to be valid.  

There are Summary of product characteristics and Package leaflet for each medicine from the database.

Register of human medicines is available here.

Summary of product characteristics (SmPC) is a summary of expert information on a medicine approved within the marketing authorisation issuance procedure and intended for the expert public.

Package leaflet (PL) is a document intended for a user, which is attached to a medicine and contains information about it.

Labelling of a medicine includes the data from outer, or immediate packaging.

In accordance with the Law on Medicinal Products, Rulebook on more detailed conditions for issuance of marketing authorisation for a medicinal product, Rulebook on the contents and method of labelling the outer and immediate packaging of a medicine and contents of the package leaflet, the documentation required for obtaining marketing authorization must contain proposals of Summary of product characteristics, Package leaflet and immediate and outer packaging (labelling).

Proposals of SmPC, Package leaflet and labelling are submitted within the Module 1 of marketing authorisation dossier in line with Instruction on submitting application and documentation for obtaining marketing authorisation for medicines for human use available on the portal of the Institute, in the section Instructions and forms.

When creating proposals of SmPC, Package leaflet and labelling for Montenegro, please use following forms:

• SmPC form  (updated 18.9.2024.)
• Package Leaflet form (updated 18.9.2024.)
• Labelling form (updated 25.5.2020.)
  Note: The labelling form for immediate and outer packaging of a medicine is used for packaging proposals in Montenegrin only.

Proposals of SmPC, Package leaflet and labelling and all following versions of these documents containing corrections, shall be submitted to the Institute in docx format.

Instructions

• Manner of submitting application and documentation for obtaining marketing authorization for medicines for human use (updated 25.8.2025.)
• Manner of submission of application and documentation for the transfer of marketing authorisation to the other marketing authorisation holder (updated 17.2.2023.)
• Manner of submitting application and documentation for the renewal of marketing authorisation for medicines for human use  (updated 25.8.2025)
• Manner of submitting application and documentation for variations  (published 16.1.2026.)
• Manner of submitting application and documentation for notifications (published 8.9.2025.)

Forms

• Application form for the issuance of marketing authorisation for a medicine (updated 28.12.2022.)

• Cover letter – issuance of marketing authorisation for a human medicine (update 25.02.2026.)

• Application for notification/approval of the variation (updated 16.2.2026.)

Note: Variations are classified in accordance with the Regulation 1234/2008/EC and Guidelines 2013/C 223/01 on variations of European Union.

• Notification on placing a medicine on the market (update 25.02.2026.)
• Application for the transfer of marketing authorisation to the other marketing authorisation holder (updated 17.2.2023)
• Application for the renewal of marketing authorisation for medicines  (updated 2.8.2023.) 
• Cover letter – issuance of the renewal of marketing authorisation for medicines
• Application for cesation of validity of marketing authorisation for a medicine (updated 17.2.2023)
• Notification form (update 25.02.2026.)