Moldova to regulate the production, distribution of medicines according to European standards

The parliament has voted, in the second reading, on a draft law that modernizes the entire process of authorizing, manufacturing, importing and distributing medicines, aligning the legal framework with European Union standards

The draft law, presented in plenum by MP Adrian Belii, establishes clear rules regarding the testing, labeling, pharmacovigilance, pricing, advertising and monitoring of medicines. It also introduces the possibility of parallel import, which will allow the acquisition of authorized medicines in other countries, but which are not available on the local market.

An essential element of the reform is facilitating Moldova’s participation in international clinical trials and attracting foreign investors in the pharmaceutical industry.

The new regulations include stricter measures to prevent the counterfeiting of medicines, including personnel assessment inspections and pharmacovigilance system evaluations, conducted by the Medicines and Medical Devices Agency.

The draft was developed by the Ministry of Health, in collaboration with the Medicines Agency, and was consulted with the World Health Organization.