Skopje, 27 March 2026 (MIA) – Health Minister Azir Aliu said at Friday’s press conference that a new law on medications, aligned with European standards will be published on the National Electronic Register of Regulations (ENER) next week.

He noted that the current legal framework on medications is outdated and that there is a need to align it with European regulations. He also informed that work on the new legal solution has been ongoing for three years.

“Through this law, we are introducing modern measures to ensure more efficient and faster processes for the approval and registration of new medications. We are establishing a system to monitor supply and prevent shortages, along with advanced electronic tools for tracking and analyzing consumption. Our goal is to create a more efficient and safer system for all citizens,” Aliu said.

He added that the law strengthens control of medicaments at all stages, while the monitoring of adverse effects introduces organized tracking of safety signals and improved coordination between the Ministry of Health, the Health Insurance Fund, and the Medicines and Medical Devices Agency (MALMED) through the digitalization of processes and interoperability between institutions.

“Clinical trials will be aligned with EU regulations and conducted in accordance with the principles of the Good Clinical Practice guidelines, ensuring greater rights for participants and mandatory approval from an ethics committee before the trial is carried out,” Aliu said.

He also announced that pharmaceutical waste from households will be collected at designated points within a national network.

Photo: MIA