Application for marketing authorization shall be submitted to the Institute. According to the Law, an applicant for marketing authorization may be a natural or legal person established 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 EU dossier form.

In addition to laws and rulebooks applicable in Montenegro, when evaluating documentation, European and international regulation is also applied, mainly guidelines for the assessment of quality, safety and efficacy of European Medicines Agency (EMA) .

In accordance with the Law, the Institute establishes Commission for placing medicinal products on the market, as an advisory body.

More information about the Commission for placing medicinal products on the market along with agendas is available here.

Institute shall issue a national marketing authorisation valid on the territory of Montenegro. Authorisations issued in other countries do not have validity in Montenegro, but every medicinal product has to go through a marketing authorisation issuance procedure in the Institute. Nevertheless, if  a medicinal product has beed granted maketing authorisation in the EU, in accordance with the Law on Medicinal Products, evaluation process may be shortened with acceptance of relevant expert opinions.

Integral parts of marketing authorization are Summary of Product Characteristics (SmPC) which is intended for expert public, i.e. veterinary professionals and Package Leaflet (PL), intended for a user of the medicinal products, i.e. person administering a medicinal product and is in line with Summary of Product Characteristics.

The Institute shall publish information on veterinary medicinal products that have been granted marketing authorization, together with the approved summaries of product characteristics and package leaflets on its portal.

Register of veterinary medicinal products is available here.

In accordance with the Law on Medicinal Products 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 medicine on the market for each pharmaceutical form, strength and packaging. This is done using the form – Notification of placing a medicine on the  market.

After obtaining marketing authorisation, marketing authorisation holder is obliged to follow the latest scientific-technical developments and data on safety and efficacy of the medicinal product 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 medicinal product and conditions of issued marketing authorisation.  

Application for notification/approval of the variation shall be submitted to the Institute using the form Application for notification/approval of the variation.

Along with the application for amendments approval, marketing authorisation holder shall submit data and/or 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 medicinal product shall be submitted to the Institute not later than nine months before marketing authorisation ceases to be valid.

Marketing authorisation may be renewed for a further period of next five years based on reassessment of the medicinal prroduct’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 medicinal product that obtained marketing authorisation is safe, it shall issue marketing authorisation for an indefinite period.

Application for transfer of marketing authorisation shall be submitted to the Institute in line with the instruction Instruction for submitting application and documentation for the transfer of the marketing authorisation for a veterinary medicinal product using the form Application for the transfer of marketing authorisation for veterinary medicinal product.

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

The labelling and package leaflet of a veterinary medicinal product shall be consistent with the approved Summary of Product Characteristics.

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

Summary of product characteristics template for a veterinary medicinal product (6.4.2026.)

Package leaflet template for a veterinary medicinal product (6.4.2026.)

Labelling template for a veterinary medicinal product (6.4.2026.)

Combined label and package leaflet template for a veterinary medicinal product (6.4.2026.)

Product information should be provided in accordance with the QRD veterinary product-information annotated template (English) version 9.1 published on the EMA website, that is available here

Previous templates for product information

Note: Veterinary medicinal products that are labelled and have a package leaflet approved in accordance with the regulations in force until the date of entry into force of the Law on medicinal products (“Official Gazette of Montenegro”, No. 14/26)   shall be brought into line with the provisions of this Law no later than 29 January 2027.

SmPC form for a veterinary medicinal product (updated 28.9.2021.)

SmPC form for an immunological veterinary medicinal product (updated 28.9.2021.)

PL form for a veterinary medicinal product (updated 28.9.2021. )

PL form for a veterinary medicinal product (applies from 01.12.2023. on)

Labelling form for a veterinary medicinal product (updated 28.9.2021.)

Labelling form for a veterinary medicinal product (applies from 01.12.2023. on)

Note: Form for the labelling of immediate and outer packaging of a veterinary medicinal products shall be used for the proposals in Montenegrin only.

Instructions

Manner of submitting application and documentation for obtaining marketing authorisation for veterinary medicinal products (updated 5.3.2026.)

Instruction for submitting application and documentation for the transfer of the marketing authorisation for a veterinary medicinal product (updated 16.3.2026)

Manner of submitting application and documentation for variations (updated 04.3.2026.)

Forms

Note:  documents in Montenegrin  

Application form for issuance of marketing authorisation for a veterinary medicinal products (updated 28.12.2022.)

Template – the Power of Attorney for representation in the MA procedure for VMP (5.3.2026.)

Cover letter for the issuance of marketing authorisation for a veterinary medicinal product  (updated 26.02.2026.)

Notification of placing a medicinal product on the  market (26.02.2026.)

Cover letter for notification/approval of the variation for veterinary medicinal product  (18.02.2026.)

Application for notification/approval of the variation (updated 20.2.2026.)

Application for the transfer of marketing authorisation for veterinary medicinal product (updated 16.3.2026)

Application for the renewal of marketing authorisation for medicinal products 

Application for the cessation of validity of marketing authorisation (17.2.2023.)

Application form for the issuance of expert opinion within competences of the Institute for medicines and medical devices shall be submitted to the Institute using the form Application form for the issuance of expert opinion within competences of the Institute.

Application for expert opinion may refer only to one of the areas listed on the form. In case that applicant intends to apply for expert opinion referring to more than one area, it is necessary to submit separate application form for each one.

Application for issuance of expert opinion on the exemption from approved packaging shall be submitted to the Institute in accordance with the instruction – Documentation required for issuing expert opinion on the exemption from approved packaging.

Institute has the competence in issuing expert opinion on classification of a product into a medicinal product or group of medicinal products. For this purpose, it is necessary to submit documentation in line with the instruction – Documentation required for issuance of expert opinion on classification of a product into a medicinal product or group of medicinal productss.

More information on how to submit an application and required documentation for issuance of expert opinion is available in the section Expert opinions and CPP.

Fees for performing activities from the scope of competences of the Institute, are determined, in accordance with the Law on medicinal products and Law on medical devices, by appropriate decisions approved by the Government of Montenegro, i.e. Steering Committee of the Institute.

Information on the fees for the exercise of competences of the Institute for medicines and medical devices that are determined by the law is available in the section Price list.