{"id":7559,"date":"2022-11-15T00:26:44","date_gmt":"2022-11-15T00:26:44","guid":{"rendered":"https:\/\/cinmed.me\/veterinarski-lijekovi\/izdavanje-dozvole-za-lijek\/"},"modified":"2026-04-07T13:49:36","modified_gmt":"2026-04-07T11:49:36","slug":"placing-a-medicine-on-the-market","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/veterinary-medicines\/placing-a-medicine-on-the-market\/","title":{"rendered":"Placing a medicine on the market"},"content":{"rendered":"\t\t
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In accordance with the Law on Medicinal Products<\/a>, a medicinal product that have a marketing authorized may be marketed and used in Montenegro. \u00a0<\/p>

Institute for medicines and medical devices is, according to the Law on Medicinal Products<\/a>, responsible for issuance of marketing authorization for a medicinal product.<\/p>

For the purpose of obtaining marketing authorisation, a medicinal product must be pharmaceutically, pharmacologically-toxicologically and clinically tested and the documentation on it shall be submitted to the Institute.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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<\/i><\/span><\/i><\/span>Placing a veterinary medicinal product on the market <\/span><\/i><\/div>

Application for marketing authorization shall be submitted to the Institute. According to the Law, an applicant for marketing authorization\u00a0may be a natural or legal person established in Montenegro.<\/p>

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<\/a>\u00a0 be submitted in EU dossier form.<\/p>

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)<\/em><\/a> .<\/p>

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

More information about the Commission for placing medicinal products on the market<\/em> <\/strong>along with agendas is available here.<\/a><\/p>

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 \u00a0a medicinal product has beed granted maketing authorisation in the EU, in accordance with the Law on Medicinal Products<\/a>, evaluation process may be shortened with acceptance of relevant expert opinions.<\/p>

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.<\/p><\/div>\n\t\t\t\t\t<\/div>

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<\/i><\/span><\/i><\/span>Register of veterinary medicinal products<\/span><\/i><\/div>

In accordance with the Law on Medicinal Products<\/a> the Institute shall publish information on veterinary medicinal products that have been granted marketing authorization on its portal.\u00a0<\/p>

For each medicinal product 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:<\/p>