Application for marketing authorization shall be submitted to the Institute. According to the Law, an applicant for marketing authorization may be:

– manufacturer seated in Montenegro, or its representative, or agent that is seated in Montenegro;

– for medicine’s manufacturer who is not seated in Montenegro, its representative, or its agent who is seated in Montenegro;

– representative of a foreign legal person who is not the manufacturer of a medicine in question, but is a marketing authorisation holder in European Union member states who is seated in Montenegro.

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, in accordance with applicable legislation. In case that the application is incomplete, the Institute requires in writing that the applicant supplements the documentation with necessary data and sets the deadline for it.

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.

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 Law on medicines, the Institute for medicines and medical devices establishes the Commission for placing medicines on the market, as an advisory body.

Commission for placing medicines on the market is an expert body performing the tasks related to issuance and renewal of marketing authorization and approval of amendments to marketing authorization for a medicine (variations).

Members of the Commission may be permanent members, or members engaged upon invitation for specific types of medicines.

 Mandate of permanent members of the Commission is four years and they may be re-elected.

Commission is expert, independent and stand-alone within its domain.

Please find below agendas of Commission’s sessions:

In accordance with the Law on medicines, marketing authorisation holder is obliged to inform in writing the Institute on the date of placing the medicinal product on the market within 15 days from the date of placing the medicinal product on the market for each pharmaceutical form, strength and packaging.

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 24.7.2024).

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 61 of the Law on Medicines, the Institute publishes on its portal information on issued marketing authorisations, summaries of product characteristics, package leaflets and conditions under which the authorisation was granted with deadlines for fulfilling those conditions, as well as on marketing authorisations that 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.

When issuing marketing authorization for a medicine, the Institute also determines its dispensing mode, i.e. whether a medicine is only permitted to be dispensed with a medical prescription, or without it.

Additionally, it specifies non-prescription medicines that may be advertised in the media, as well as in other manners. Information about these medicines may only be provided in accordance with approved Summary of the characteristics of the medicine, a document that is an integral part of marketing authorisation.

In accordance with Article 199 of the Law on medicines the list of non-prescription medicines that may be advertised in the media is available on the portal of the Institute. 

• List of non-prescription medicines that may be advertised in the media

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 medicines, 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

• Instruction on submitting application and documentation for obtaining marketing authorisation for medicines for human use (updated 24.5.2022.)
• 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 20.5.2024)
• Manner of submitting application and documentation for variations  (published 09.7.2024)

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

• Application for notification/approval of the variation (updated 24.7.2024.)

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
• 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)