Central Project Management Agency (CPMA) in cooperation with the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (VVKT) completed the EU funded Twinning project „Harmonisation of the legislation for medicinal products with EU legislation and building capacities for its implementation“ in North Macedonia.
The project played a key roll in assitance to reform the Agency for Medicines and Medical Devices in Northern Macedonia (MALMED) in accordance with international standards and good pharmaceutical practices, and harmonized the adoption and implementation of national pharmaceutical legislation with EU legislation.
In total, 26 legislative documents of the Republic of Northern Macedonia were reviewed, MALMED experts in Lithuania improved their knowledge in the fields of drug use, monitoring system, marketing authorization procedure, clinical trials and inspections, and performed 4 joint inspections with VVKT control specialists.
The project lasted 10 months and had a budget of 250,000 EUR.
During the last steering committee / closing event of the project, the respective Project Leaders Mr. Gytis Andrulionis, director of VVKT, and North Macedonia Mrs. Merjem Haxhihamza, Head of the Medicines and Medical Devices Information Department of MALMED, together with the director of the MALMED Mrs. Visara Riza, representatives from the European Union Delegation to North Macedonia and the Ministry of Health of the Republic of North Macedonia expressed their gratitude towards effective work between all the institutions. They all agreed that the successfully finished project is an excellent base for initiating new projects that would allow strengthening and developing the achieved results, as well as deepen the cooperation and collaboration between medicines regulatory bodies of Lithuania and North Macedonia.
The EU funded Twinning Program supports cooperation between sister institutions in different countries, strengthens the administrative capacity of the beneficiary countries and helps them to adapt the union acquis.