Market requirements · MD
Moldova
Moldova replaced its medicines statute in 2025: Law No. 153 of 19 June 2025 was published in the official gazette on 17 July 2025, repealing the 1997 act. The regulator is the Agency for Medicines and Medical Devices, and classification turns on entry in the State Nomenclature of Medicines. The new law simplifies authorisation and import for medicines from EU member states, but simplification is not automatic recognition and a Moldovan authorisation is still required.
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The regime
How compounds are classified in Moldova
| Governing law | The governing act is Law No. 153/2025 on medicinal products, in force from publication on 17 July 2025, sitting alongside the 1993 law on pharmaceutical activity, which is the licensing base for wholesale and import operators. Consignment-level import is governed by agency Order No. 1 of 16 January 2006 approving the regulation on authorising import and export of medicines, amended in 2011 and again in 2022. Controlled substances are separately regulated by the 1999 law on the circulation of narcotic and psychotropic substances and precursors and by Government Decision No. 1088/2004. VAT is set by Article 96 of the Fiscal Code. |
|---|---|
| What determines classification | The agency decides through its medicines commission, and the operative record is the State Nomenclature of Medicines. The Fiscal Code mirrors that register for tax purposes: the reduced rate attaches to goods under tariff headings 3001 to 3004 that are either listed in the nomenclature or authorised by the health ministry, so a product outside both is neither treated as a medicine for tax nor authorised for sale. The customs service applies the same law at the border and states plainly, citing Law No. 153/2025, that import and export of medicines by natural persons is prohibited, with personal baggage the only exception. A buyer cannot therefore use an individual as an import route. |
| EU candidate and recognition of foreign authorisations | Moldova is an EU candidate operating a deep and comprehensive free trade area and has aligned its medicines framework to European directives. The agency describes Law No. 153/2025 as an essential step in that alignment and lists among its principal provisions the simplification of authorisation and import procedures for medicines from EU member states. On the specific question: this is a simplified pathway resting on the assessment already performed in a reference jurisdiction, not automatic recognition. A European marketing authorisation on its own does not permit sale in Moldova, and the product must still be authorised nationally and entered in the nomenclature. The agency also maintains operational accommodations, for example an order of December 2024 approving import of authorised medicines in Ukrainian-language packaging. On Transnistria there is no published position, so none is asserted. |
| Prescription and controlled substances | Not established for named peptides. Prescription or over-the-counter status follows agency and health-ministry classification orders applied to the specific authorised product, including the 2010 order on classification of authorised medicines and the criteria for legal status on dispensing. Narcotic and psychotropic control runs through the 1999 law and Government Decision No. 1088/2004, and no named research peptide was found in those tables. One dated development matters here: Law No. 174 of 27 June 2025 on preventing and combating illicit trafficking in doping substances was published in the same gazette edition of 17 July 2025. Whether it names peptide substances is unverified, and no published list was found. |
| Enforcement posture | The agency is administratively active but no peptide-specific enforcement was found. It publishes monthly authorisation decisions, maintains published lists of rejected and withdrawn medicines, runs manufacturing, distribution and pharmacy inspection programmes with published tariffs, and announced in August 2026 that it is receiving Polish expertise to strengthen inspection capacity. No published enforcement action against the import or resale of research peptides was found on either the agency or the customs service site. That is an absence of published evidence rather than evidence of tolerance. |
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Your obligations
What a buyer in Moldova needs settled
- Hold an agency licence for pharmaceutical activity covering wholesale distribution or import before contracting, applying through the single-window permit service.
- Obtain an agency import authorisation for each transaction under the regulation approved by Order No. 1 of 16 January 2006, and attach the required specification annex to the contract.
- Confirm every product is entered in the State Nomenclature of Medicines before ordering, and do not accept a European marketing authorisation as a substitute for Moldovan authorisation.
- Budget 8 per cent import VAT only for goods under tariff headings 3001 to 3004 that are in the nomenclature or health-ministry authorised, and budget the standard 20 per cent for everything else.
- Never route a commercial consignment through a natural person, because the customs service states that import and export of medicines by natural persons is prohibited.
- Keep good distribution practice records and a named pharmacovigilance contact for inspection, and retain the import authorisation and specification for each consignment.
We will ask about this at enquiry. We check the authorisations your activity requires before quoting, and we confirm the position per compound rather than for the market as a whole.
Sources
Check this yourself
Every position above traces to a dated public document. The authority, the document, the date and the link are below.
| Authority and document | Date | Link |
|---|---|---|
| Monitorul Oficial al Republicii Moldova Edition 372-374: Law No. 153 of 19 June 2025 on medicinal products, and Law No. 174 of 27 June 2025 on doping substance trafficking | 2025 | monitorul.gov.md/ro/monitor/3124 |
| Agency for Medicines and Medical Devices Publication of the law on medicinal products, listing its principal provisions | 2025 | amdm.gov.md/ro/news/legea-cu-privire-la-medicamente-public... |
| Agency for Medicines and Medical Devices Authorisation of import and export of medicines, Order No. 1 of 2006 and subsequent orders | 2006 to 2024 | amdm.gov.md/ro/page/autorizarea_import_export_medicamente |
| Customs Service of the Republic of Moldova Medicines: import and export by natural persons prohibited under Law No. 153/2025 | 2025 | customs.gov.md/en/articles/medicamente-1915-ro |
| Agency for Medicines and Medical Devices Licensing of pharmaceutical activity: legislation, guide and licence register | 2026 | amdm.gov.md/ro/page/legislatie_licentiere_ |
| Agency for Medicines and Medical Devices Legislation index, including the 2010 order on classification and legal status on dispensing | 2026 | amdm.gov.md/en/page/legislation |
Links go to the issuing body wherever one exists. Positions change. If you are relying on any of this, check the source rather than this page.
Market brief
Take the Moldova brief as a PDF
The regime, the buyer obligations and all 6 sources, dated and linked, in one document you can forward.
Nearby
Eastern Europe and nearby markets
Buyers supplying one of these usually supply the others. The requirements are not the same.
| Code | Market | Sources | |
|---|---|---|---|
| UA | Ukraine | 6 sources | Ukraine regulates medicines under the Law on Medicinal Products of 4 April 199... |
| RS | Serbia | 5 sources | Serbia applies the Law on Medicines and Medical Devices, published in the offi... |
| BA | Bosnia and Herzegovina | 5 sources | Bosnia and Herzegovina applies a single state-level act, the Law on Medicinal ... |
Scope
How to use this page
A summary of the published regulatory position in Moldova as at 2026-08-20, written for procurement teams deciding how to source. Every source is dated and linked so it can be checked at origin.
It is not legal advice. Full terms of supply, including where responsibility sits, are set out in our terms of supply.
Questions
Supplying into Moldova
Do you supply into Moldova?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Moldova depends on that compound and on your authorisations, and we confirm it per compound at the enquiry stage.
Who carries the compliance obligation?
The importer of record and the party placing the product on the market, which is the buyer. We supply the batch documentation that supports your file. We cannot hold your authorisations for you.
How current is this page?
It was reviewed on 2026-08-20 and is scheduled for review again on 2026-11-18. Every source is dated and linked, so you can check the original.
We already supply into Moldova. What changes if we source from you?
The batch documentation. You receive a Certificate of Analysis per batch, which can be issued under your own brand. The import and market-placing responsibilities stay where they are.
Is this legal advice?
No. It is a summary of the regulatory positions those authorities have published, as at the review date above. Take advice in your own market before you rely on it.
Enquire about supply into Moldova
Tell us the compounds and your authorisations. We confirm per compound before anything ships.