Placing a medicine on the market
Medicine for which marketing authorisation has been issued by the Institute may be placed on the market and used in Montenegro.
Institute shall issue marketing authorisation on the basis of a positive assessment of the documentation on pharmaceutical-chemical-biological tests, safety and residue tests of a veterinary medicine, i.e. safety test of an immunological veterinary medicine, preclinical and clinical tests and efficacy tests of immunobiological veterinary medicines, documenting
- and efficacy of a medicine.
The task of the benefit – risk ratio evaluation is very complex and takes into account, among other things, characteristics of active substances and pharmaceutical form of a medicine (tablets, injections), diseases and conditions a medicine is intended for, duration of the treatment…
Beside 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 medicines on the market, as an advisory body.
More information about the Commission for placing medicines 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 medicine has to go through a marketing authorisation issuance procedure in the Institute. Nevertheless, if a medicine has beed granted maketing authorisation in the EU, in accordance with the Law on Medicines, evaluation process may be shortened with acceptance of relevant expert opinions.
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.
Application for marketing authorisation for a veterinary medicine shall be submitted to the Institute in line with Instruction – Manner of submitting application and documentation for obtaining marketing authorisation for veterinary medicines.
In accordance with the Article 61 of the Law on medicines the Institute shall publish information on veterinary medicines that have been granted marketing authorization on its portal.
For each medicine in the database, wordings of reference documents are available which are approved in the procedure of the issuance of marketing authorization and are an integral part of the marketing authorisation:
- Summary of Product Characteristrics – SmPC – intended for expert public, i.e. veterinary professionals and contains essential information on safe and effective use of a medicine;
- Package leaflet – PL – attached to a medicine and contains information on a medicine intended for a user of the medicine, i.e. person administering a medicine and is complied with the Summary of product characteristics.
SmPC and PL contain accepted attitudes towards specific medicines that were formed during the assessment process of the documentation of the medicine and are approved by the Institute. Therefore, the approved SmPC and PL represent an inseparable and integral part of marketing authorisation, and once accepted, they must not be amended without prior approval of the Institute.
After the issuance of marketing authorisation, marketing authorisation holder shall inform the Institute about all new findings on quality, safety and efficacy of a medicine, through the procedure of amendments (variations) to marketing authorisation approved by the Institute. Marketing authorisation holder shall include all approved variations that amend the wording of SmPC and PL into the documents that are attached to the marketed medicine.
When searching the Register, multiple offered parameters can be used. It takes only to enter part of the name into the field, using either lower, or upper case.
Register of veterinary medicines is available here.
In accordance with the Law on medicines marketing authorisation holder is obliged to inform in writing the Institute on the date of placing the medicine 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 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 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 medicine 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 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 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 using the form Application for transfer of marketing authorization to the other marketing authorization holder.
Application for the cessation of validity of marketing authorisation shall be submitted to the Institute using the form Application for the cessation of validity of marketing authorisation.
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 medicine or group of medicines. 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 medicine or group of medicines.
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 medicines 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.
Note: documents in Montenegrin
Application form for issuance of marketing authorisation for a veterinary medicine (updated 28.12.2022.)
SmPC form for a veterinary medicine (updated 28.9.2021.)
SmPC form for an immunological veterinary medicine (updated 28.9.2021.)
PL form for a veterinary medicine (updated 28.9.2021. )
PL form for a veterinary medicine (applies from 01.12.2023. on)
Labelling form for a veterinary medicine (updated 28.9.2021.)
Labelling form for a veterinary medicine (applies from 01.12.2023. on)
Note: Form for the labelling of immediate and outer packaging of a veterinary medicines shall be used for the proposals in Montenegrin only.
Notification of placing a medicine on the market (17.2.2023.)
Application for notification/approval of the variation (updated 31.12.2021.)