The government today, March 18, on the initiative of the Health Ministry, approved new Good Manufacturing Practice (GMP) rules for medicines. The document creates a basis for the application of European norms, ensuring compliance of medicines with European safety requirements.
Both local manufacturers and importers will now require only two supporting documents instead of the previous four: a production and import authorization from the Agency for Medicines and Medical Devices (AMDM) and a GMP certificate of compliance.
The new rules also regulate the production of medicines intended not only for human treatment, but also for clinical trials. Control has been strengthened not only over domestic production, but also over imported medicines, the departmental report said.
The agency is introducing stricter measures to prevent counterfeit products. As part of the reform, digital monitoring systems (“track and trace”) are being introduced to control the path of each package from the factory to the pharmacy.
Why is this important now?
Adoption of new GMP rules is part of a large-scale reform of the pharmaceutical sector in Moldova, envisioned by the new Law on Medicines. It will allow the country not only to improve the safety of medicines for citizens, but also to attract foreign investors to the local industry.
Also, as of March 11, 2026, new rules for the control of residues of pharmacologically active substances came into force, which complements the system of ensuring the safety of medicines in the country.
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