Moldova is proposing a new framework for the temporary import and use of medicines that are not authorised nationally or are effectively unavailable, replacing the narrower exceptional-import rules established in 2024.
The Ministry of Health (Ministerul Sănătății, MoH) proposal covers patients without an effective authorised alternative, complex oncology and hospital therapies, continuation of treatment started abroad, medicine shortages and public-health emergencies. It would also implement treatment-of-last-resort programmes created by the 2025 medicines law, allowing qualifying innovative medicines in development or undergoing authorisation to be supplied free by manufacturers.
Applications would normally be assessed within 30 days. This would fall to five days for urgent cases and critical essential medicines, 24 hours where life is imminently threatened and 48 hours for medicines placed on a pre-authorised list. Medicines authorised in Romania or specified EU partner countries would have a five-working-day route.
Individual use would require approval by a hospital medical council and informed patient consent. Temporary authorisations could last up to 12 months and be renewed without repeating the complete assessment, while patients already receiving treatment could use existing stocks for a further 90 days after expiry.
The Medicines and Medical Devices Agency (Agenția Medicamentului și Dispozitivelor Medicale, AMDM) would also maintain public lists of missing essential medicines and temporary authorisations, accept quality evidence from specified stringent regulatory authorities without duplicate documentation and operate an out-of-hours urgent application channel.
The September text follows an initial consultation in June and is undergoing a second consultation until 24 September. The revised proposal explicitly covers both temporary import and use and incorporates feedback received during the earlier consultation, while retaining the wider objective of creating a faster legal route where normal registration or supply cannot meet an immediate treatment need.
Source: Ministry of Health, Moldova
Link: Acces rapid și sigur la tratamente moderne lipsă de pe piața națională: Ministerul Sănătății supune consultării publice proiectul de ordin (Rapid and safe access to modern treatments unavailable on the national market: Ministry of Health opens draft order for public consultation)
Date: 15 September 2026
Source: Government of the Republic of Moldova, Particip.gov.md
Link: Inițierea elaborării proiectului de modificare a Ordinului Ministerului Sănătății nr. 395/2024 cu privire la aprobarea Regulamentului privind autorizarea importului medicamentelor și/sau materiei prime medicamentoase neautorizate în Republica Moldova (Development of amendments to Ministry of Health Order No. 395/2024 on authorising the import of unregistered medicines and medicinal raw materials)
Date: 10 September 2026
