The Montenegrin Institute for Medicines and Medical Devices issued 231 decisions last year on issuing marketing authorizations for medicines, while in 21 cases it accepted requests to abandon the registration process for medicines, which companies submitted mainly for commercial reasons, i.e. a small market.
According to the institution's annual report, the Institute operated positively last year, with a result of 2,2 million, while the previous year, 2023, also ended positively with a result of 1,8 million.
Last year, the Institute states, the Sampling Plan was successfully initiated and implemented in the Laboratory of that institution. Out of the planned 222 drugs, 175 were sampled and analyzed.
They claim that laboratory controls in 2024 did not register any occurrences of counterfeit medicines or those that do not meet the approved specifications and prescribed quality standards.
The report states that the inspection detected irregularities in nine samples during the phase of assessing the packaging of the drug in relation to what was approved. It also states that analyses were conducted for 18 samples for commercial purposes, at the request of individuals and legal entities.
Last year, the Institute received 180 applications for drug registration, as well as 2.659 applications for amendments to drug licenses. Companies also submitted 167 applications for renewal of drug licenses, as well as 16 applications for termination of their validity.
According to a report adopted by the Government, a total of 536 import permits for medicines for human use that do not have a marketing authorisation were issued last year, through so-called emergency imports. They claim that the number of import permits issued has fallen over the past decade, as 10 years ago the market was mostly supplied with medicines through the emergency import mechanism.
"It can be concluded that in the last four years, intervention imports have been of stable volume with minor variations, which are mainly influenced by unforeseen health situations, as well as the emergence of new therapeutic options for certain diseases. For each individual request for approval to import a medicine that does not have a marketing authorization in Montenegro, the justification for the import is determined, taking into account the existence of parallels that have received a marketing authorization in Montenegro, as well as the reasoned request of the import proposer," the Institute claims.
They emphasize that they have prioritized processing requests for approval to import vaccines, as well as all other medicines that belong to the risky category (blood and plasma medicines, immunological medicines).
"During 2024, 56 licenses were issued for the import of 19 immunological medicines and blood and plasma medicines that have a marketing authorization, and which belong to the category of risky medicines that require approval for the import of each batch...", the Institute says, explaining that last year, for the first time since emergency imports began, the Rulebook was adopted, detailing the conditions for issuing approval for the import of a medicine that does not have a drug license.
The Institute had 73 employees at the end of last year. The report states that 17 new employees started working, while six terminated their employment by mutual consent.
According to the report, the Institute began work on setting maximum drug prices last year, immediately after the new Regulation came into force in March. Last year, prices were set for a total of 1.312 drugs.
"Since the international price comparison (IPR) methodology, which is the most commonly used methodology in most European Union countries, is used to establish maximum drug prices, the change to the Regulation in 2024 related to the change of one of the reference countries. The reference countries in the previous Regulation were the Republic of Serbia, the Republic of Croatia and Romania. The Republic of Croatia (Croatian Health Insurance Institute), by amending the Law on Health Care of the Republic of Croatia, prescribed that the prices on the Croatian List of Drugs are not published on the portal of the Croatian Health Insurance Institute, which caused a new reference country with transparent drug prices to be selected instead of Croatia. After detailed analyses, the Czech Republic was selected as the reference country instead of Croatia. If it is not possible to determine a comparable price in any of the listed countries, the reference country is the European Union country in which the drug is manufactured, or in which the drug has received a marketing authorization, with the lowest comparable drug price," they explained.
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