After 19 years and more than 20 amendments to the law currently in force, the authorities are preparing a new law on medicines aimed at full alignment with European legislation. Health Minister Sasho Klekovski announced this following a national consultation on the issue.
Representatives of patient associations, pharmaceutical chambers and the pharmaceutical industry took part in the consultation, along with experts and representatives of government institutions.
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Klekovski explained that the new framework will replace the current law, adopted in 2007. Medicines and medical devices will be covered by separate laws, while a dedicated law on pharmaceutical activities is also expected to be adopted at a later stage.
“For patients, a well-organized medicines system means receiving treatment on time, having confidence in its quality and safety, and getting accurate information on its use,” the minister said.
Planned steps include reviewing all submitted comments, creating stronger mechanisms to prevent medicine shortages, and making it easier to report adverse reactions. A plan for implementing the law will also be prepared in cooperation with the Agency for Medicines and Medical Devices (MALMED).
“The value of the law depends on its implementation. For this reason, every new obligation must specify who will carry it out, with what staff and resources, and within what timeframe,” Klekovski said.
The process is being carried out with the support of the World Health Organization (WHO) in Macedonia.
