Implementing institutions
Ministry of Health of the Republic of Lithuania, State Medicines Control Agency of Lithuania, National Health Insurance Fund under the Ministry of Health of the Republic of Lithuania, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Objective of the project
The MMDA is a health agency in transition. Currently the EU acquis regarding medicinal products and medical devices is transposed into Moldovan legislation. Adopting laws is only the first step which has to be followed by adoption of EU regulatory practice as well as implementation of the EU principles and standards. Strengthening of this practice, with regards to clinical trials, marketing authorisation, manufacturing and distribution authorisation, vigilance, central procurement, pricing, reimbursement and distribution of medicinal products and medical devices, authorisation of pharmaceutical activity as well as supervision and reinforcement, is the main purpose of the twinning project. The completion of this project should deliver a health agency with capacities at the same level as peer institutes in the EU member states. The MMDA should be able to cooperate in the EU networks of regulatory agencies.
