AmCham Healthcare Committee started the season by meeting with the Medicines and Medical Devices Agency to discuss new pharmacovigilance rules, focusing on mechanisms, deadlines, and categories of safety reporting, including via electronic means. A detailed Q&A document is now available for further reference and guidance on the matter, rendering more predictability and transparency.
Later in September, the Committee had a meeting regarding state’s price control regulations on drugs, in the context of public consultations launched by authorities. In the aftermath of this meeting, the Committee issued a letter to state authorities, asking for more alignment with the standards on over-the-counter drugs pricing applied by EU countries.
Another point of debate was the transition of EU drug manufacturers to new two-dimensional codes appearing on the packaging of pharmaceuticals, and the potential consequences of these changes in the light of national legislation on packaging. In order to avoid any disruptions in the imports of medicines from EU to Moldova, a letter articulating the issue will be sent to authorities.