Both the public bodies in charge with public health and pharmaceutical industry should make substantive efforts to master challenges on harmonisation of regulatory framework for pharmaceuticals and medical devices with EU standards. This was concluded by an expert group that analysed Serbian regulations’ compliance with EU ones, within the PLAC project.
The PLAC project, in cooperation with the Ministry of Health, organised an expert workshop on the regulatory framework for pharmaceuticals and medical devices in the Republic of Serbia. The workshop gathered 47 representatives from public institutions, industry, academia and civil society was.
PLAC expert Tobias Schulte in den Baumen presented an analysis of the current compliance of the 2010 law on Medicinal Products and Medical Devices with the acquis. The analysis was followed by recommendations for changes which are improving the approximation to standards in the European Union.
Both the analysis and the recommendations were warmly welcomed by the participants who shared their experience with the current law and who expressed their expectations for the upcoming accession phase.
Serbia will have the screening process in the field of Public Health at the end of the year 2014. Important reform steps shall already be initiated before the screening is conducted. After a welcome address of the Assistant Minister in charge of the Health Insurance Sector at the Ministry of Health, Mrs Gordana Basta, PLAC project Team Leader, Mrs Marija Pejčinović Burić provided an introduction about the project.
