Introduction

As the Republic of Moldova progresses on its journey as an EU candidate, its pharmaceutical market presents a significant and evolving opportunity for foreign manufacturers. With a regulatory landscape rapidly aligning with EU standards and a structural reliance on imported medicines, understanding this market is key to a successful entry. As a leading pharmaceutical importer and distributor in Moldova, we've created this guide to provide you with the latest market statistics and a clear, practical overview of the regulatory requirements. This manufacturer's guide on Moldova's pharma market will cover the market snapshot, the role of the regulatory authority, and the key regulatory and post-marketing obligations you need to know.

Pharmaceutical sector - Statistics

Country population: 2.381 million people (as of 01.01.2025).

Current health expenditure (2022, % of GDP): 6.97%.

Life expectancy at birth (2024): 72.0 years.

Pharmaceutical market size in EUR (2024, in manufacturer prices): €273 million, with 93% representing imported pharmaceuticals.

Pharmaceutical market size in packs (2024): 99.11 million, with ~85% representing imported pharmaceuticals.

Annual pharmaceutical expenditure per capita (2024): ~€115.

Out-of-Pocket spending on health (2022): ~31.7% of Current Health Expenditure (CHE).

The State Nomenclature of Medicines entries (29.10.2025): 6141 pharmaceuticals.

Top countries for import of pharmaceuticals (2024)

Germany (13%).
Romania (10%).
Hungary (8%).
Turkiye (8%).
Slovenia (7%).

Top imported pharmaceuticals by active substance (2024, in million EUR)

Ibuprofenum - 4.94.
Dapagliflozinum - 4.76.
Rivaroxabanum - 4.63.
Rosuvastatinum - 3.76.
Ceftriaxonum - 2.88.
Dexketoprofenum - 2.83.
Homeopatic medicines - 2.68.
Acidum acetylsalicylicum - 2.59.
Pancreatinum - 2.56.
Fluconazolum - 2.53.

Top foreign manufacturers of pharmaceuticals (2024, in million EUR)

Gedeon Richter - 16.59.
KRKA - 15.21.
Berlin-Chemie - 12.41.
World Medicine - 7.95.
Nobel - 7.90.
Abbott - 6.97
Bilim - 6.80
Bayer - 6.74
GlaxoSmithKline - 6.73
Sanofi - 6.27

Top local manufacturers of pharmaceuticals (2024, in million EUR)

SC Balkan Pharmaceuticals SRL - 16.78.
Farmaprim SRL - 3.18.
SC Flumed-Farm SRL - 1.34.
ÎCS Eurofarmaco SA - 1.08.
ElaDum Pharma SRL - 0.56.

Key Takeaways from the 2024 data

A market defined by imports: The 93% import dependency in value (€273 million) underscores a significant, structural reliance on foreign manufacturers. This is not a market where you compete against a dominant local industry; it is a market built for partners like you.
Diverse & high-standard sourcing: The top import countries are a mix of major EU players (Germany, Romania, Hungary, Slovenia) and strong regional manufacturers (Turkiye). This shows a diversified, competitive supply chain that values high-standard production (e.g., EU-GMP).
Standard European therapeutic needs: The list of top active substances—dominated by pain/inflammation (Ibuprofen, Dexketoprofenum), chronic disease (Dapagliflozin, Rivaroxaban, Rosuvastatinum), and antibiotics (Ceftriaxonum) - indicates a market with standard, European-aligned therapeutic demands.
A competitive, brand-driven landscape: The top foreign manufacturers include a healthy mix of major European pharmaceutical companies (Gedeon Richter, KRKA, Bayer, GSK, Sanofi) and powerful regional brand-generic manufacturers (World Medicine, Nobel).
The high Out-of-Pocket spending of over 31% on health underscores that the dominant sales channel for many medicines remains the private, retail pharmacy sector, meaning market success relies on effective commercial and reimbursement strategies, not just government tenders.
A "high-friction" but improving regulatory environment: While harmonization is the goal, manufacturers should know that complex registration and pricing rules have historically created market access hurdles. In fact, data from previous years (e.g., 2016-2021) showed a temporary decrease in the number of registered medicines, particularly from Europe. This trend is reversing as the new legislation (like Law 153/2025) aims to stabilize the framework. It underscores that a successful market entry requires expert regulatory navigation, not just a quality product.

The regulatory framework: harmonization with EU standards

Moldova’s journey towards European integration significantly influences its pharmaceutical regulatory landscape. The primary goal is to harmonize national legislation with the European Union (EU) acquis communautaire, particularly in the healthcare and pharmaceutical sectors. This commitment translates into a regulatory framework that is increasingly aligning with EU directives and good practices.

The main regulatory body overseeing the pharmaceutical sector in Moldova is the Medicines and Medical Devices Agency (AMDM). The AMDM is responsible for the following in the pharmaceutical sector:

Expertise of the dossier and issuance of a Marketing Authorization: All pharmaceutical products must obtain Marketing Authorization from the AMDM before they can be placed on the Moldovan market*. The process involves submitting a comprehensive dossier, mirroring the Common Technical Document (CTD) format used in the EU.
* Exceptions exist for government procurements or in the presence of a public health emergency or absence of analogues or substitutes on the pharmaceutical market.
Pharmacovigilance: The AMDM is responsible for monitoring the safety of medicines on the market, collecting and assessing adverse drug reaction reports, and implementing risk minimization measures. This system is continuously being strengthened to align with EU pharmacovigilance guidelines.
Government oversight of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Pharmacy Practices (GPP): The AMDM enforces adherence to these quality standards throughout the pharmaceutical supply chain, from manufacturing to dispensing. Inspections are regularly conducted to ensure compliance.
Manufacturer price registration of pharmaceuticals, with the establishing maximum wholesale and retail prices for medicines.
Approving and monitoring of advertising and promotion of pharmaceuticals: Regulations govern the advertising and promotion of medicinal products to ensure they are accurate, balanced, and not misleading, again drawing parallels with EU restrictions.
Specific advertising prohibitions: The alignment with EU standards includes strict rules on advertising. Manufacturers must be aware of:
- No Direct-to-Public advertising for Rx medicines: There is a strict prohibition on advertising prescription-only medicines (Rx) to the general public.
- HCP-Specific channels: Advertising for Rx medicines is permitted only in specialized medical or pharmaceutical publications and at scientific events intended for healthcare professionals (HCPs).
- Prohibited endorsements: It is illegal to use the image or name of healthcare professionals, scientists, or public figures to promote any medicinal product.
- No public sampling: Providing free samples of medicines directly to the public is prohibited. Samples can only be provided to healthcare professionals under strict conditions.

Key regulatory aspects for foreign exporters and manufacturers

For foreign pharmaceutical manufacturers and exporters, understanding the specific requirements for placing your products on the Moldovan market is the first step to a successful partnership.

Here are the critical aspects you need to manage:

Marketing Authorization

Before any product can be exported to or sold in Moldova, it must have a valid Marketing Authorization issued by the AMDM. The full process of receiving the Marketing Authorization is outlined in the Ministry of Healthcare Order no. 739/2012.

Authorization prerequisite: The medicine submitted for authorization in Moldova must already be authorized in its country of manufacture or the country where the Marketing Authorization Holder is based. If this is not the case, the product must hold an authorization from the European Medicines Agency (EMA) or in at least one EEA country or Switzerland.
Registration timeline: The registration timeline for a general authorization procedure is 210 days. If, during the expertise, it is found that the documents and information submitted are not compliant, the applicant is sent a list of objections; the authorization term being suspended (with the "timer stopped") until the applicant provides additional information.
Dossier format: The AMDM accepts registration dossiers in the Common Technical Document (CTD) format.
Language: The full technical dossier (Modules 1-5) can be submitted in English, Russian (soon the dossier in Russian may stop being accepted), or Romanian. However, product-specific documents from Module 1, such as the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and packaging mock-ups, must be translated into Romanian. AMDM may allow the use of packaging with text in a foreign language of international circulation with a leaflet in Romanian in the following cases: a) exceptional situations (cataclysms, catastrophes, epidemics, epizootics, mass poisonings, other cases threatening public health); b) medicinal products issued on the basis of a medical prescription (medicinal products for hospital use, medicinal products for special therapy, oncological medicinal products, for rare diseases, substitution therapy, vaccines, orphan medicinal products); c) medicinal products for which there is a single international non-proprietary name in the Republic of Moldova.
European pharmacopoeia compliance: The finished product specification (3.2.P.5.1. and related modules), and active substance specification (3.2.S.4.1. and related modules) must comply with the requirement of the European Pharmacopeia - the tests, acceptance criteria and analytical procedures must reference the European Pharmacopeia. The only exception is made for US-manufactured pharmaceuticals, for which United States Pharmacopeia (USP) is accepted, and for Japanese-manufactured pharmaceuticals, for which Japanese Pharmacopeia (JP) is accepted.
Finished product samples, reference standards for registration: After all dossier corrections are made according to objections by AMDM (if there are any), for the finalization of registration the finished product, you must provide product samples in sufficient quantity to ensure 3 full analyses in accordance with the quality parameters, provided for in the specification of the finished product, according to the methods presented in the analytical-normative documentation and reference substances, impurities and degradation products according to the dossier in sufficient quantity to ensure 3 full analyses. By way of derogation from the general rule, samples of finished product, reference substances, impurities and degradation products will not be submitted by manufacturers who hold a GMP certificate issued by at least one country in the European Economic Area or Switzerland, the United Kingdom, the USA, Canada, Japan, Australia or hold a GMP certificate issued by a PIC/S member state.
Simplified registration procedure: If your product is already authorized in a high-standard jurisdiction (EEA, Switzerland, USA, Canada, Japan, or Australia), Moldova offers streamlined registration, with recognition of the dossier filed in the respective jurisdiction, and a registration time of 60 working days from dossier validation.
Marketing Authorization validity: A new Marketing Authorization is valid for 5 years.
Marketing Authorization renewal deadline: The application for renewal must be submitted to the AMDM at least 9 months before the 5-year authorization is set to expire. This is a critical administrative deadline to ensure market continuity.
Marketing Authorization unlimited validity after renewal: After the first 5-year renewal, the Marketing Authorization can be granted for an unlimited period (no expiration date), unless the AMDM decides, based on pharmacovigilance data, to require one additional 5-year renewal.

Contact Us for details on obtaining the marketing authorization in the Republic of Moldova. Our experts can provide you with details and assist you with obtaining the marketing authorization in the shortest possible period.

Pricing & Reimbursement

Receiving Marketing Authorization is the first step toward placing your pharmaceutical product on the market. Next, for the importer to be able to import your pharmaceutical into the Republic of Moldova, the importer must obtain an import permit. For the import permit to be issued by AMDM, the pharmaceutical's manufacturer price must be registered in the National Catalog of Manufacturer Prices for Medicines (via the Manufacturer Price Registration process).

A) Manufacturer Price Registration (Mandatory)

Manufacturer Price – the price of the purchased goods, excluding taxes (ex works), which was declared by the manufacturer or its official representative for approval and inclusion in the National Catalog of Manufacturer Prices for Medicines.

Manufacturer Price Registration must be approved and registered by the AMDM. The process usually takes 1-2 months and and must usually be renewed annually, as the registration is typically valid for one year. It can, however, be registered for three years; this requires a special negotiation process with AMDM. The process can be handled by the manufacturer directly with AMDM or through a local representative on the basis of a power of attorney. Missing the price registration can lead to a gap in the ability to import.

This process involves submitting a detailed pricing dossier to AMDM justifying a specific Manufacturer Price. Moldova uses an External Reference Pricing (ERP) system, where your proposed price is compared against a basket of reference countries. The External Reference Pricing (ERP) system requires your proposed manufacturer price to be benchmarked against a specific basket of reference countries, which currently includes markets such as Romania, Republic of Bulgaria, Republic of Serbia, Republic of Croatia, Slovak Republic, Republic of Lithuania, Republic of Hungary, Czech Republic, Republic of Greece (Note: This list is subject to official updates).

The AMDM then approves a Maximum Manufacturer Price, which serves as the maximum import price and affects subsequent wholesale and retail markups.

The manufacturer price is approved in Moldovan Leu (MDL). The legislation specifies that this is calculated based on the average exchange rate of the 12 months preceding the application. This is a critical detail for financial planning, as it locks in an exchange rate and exposes the Manufacturing Authorization Holder to currency fluctuation risk for the duration of the price's validity.

The approved manufacturer price is valid for one year from the date of the AMDM's order. The Manufacturing Authorization Holder can apply for a price reduction at any time, but a price increase can only be requested at the time of renewal.

B) The Reimbursement List (Optional, Strategic)

To gain broad access in the public sector and ensure uptake for many chronic-care drugs, your product should be included in the List of Reimbursed Medicines. This list is managed by the National Health Insurance Company (CNAM).

This is a separate application process, often involving Health Technology Assessment (HTA) principles, where you must demonstrate your product's value and cost-effectiveness.

Our Expertise: Navigating the manufacturer price registration and compiling reimbursement dossiers is one of the more legally complex parts of market entry.

Contact Us to learn how we can manage this process for you and develop a successful market access strategy.

Good Manufacturing Practices (GMP)

Your manufacturing site's compliance with GMP is non-negotiable and is a critical part of the registration dossier. Holding a recognized GMP certificate facilitates the registration and also waives the requirement for mandatory laboratory analysis of registration samples, saving considerable time and resources:

PIC/S GMP: Moldova’s recognition of international standards is a significant benefit. If your manufacturing site holds a GMP certificate from a PIC/S member country (which includes all EU authorities, the US FDA, Swissmedic, etc.), the process of obtaining a marketing authorization is much simpler - no requirement for product samples, reference standards must be provided at the registration phase.
EudraGMP: Moldova’s recognition of EudraGMP (EU-GMP) also allows for a simpler process of obtaining a marketing authorization is much simpler - no requirement for product samples, reference standards must be provided at the registration phase.

Site inspection of the manufacturing facility may be required if PIC/S GMP or EU-GMP is not available, however site inspections are, generally, very rare. In 2025 there was only one foreign manufacturer site inspection (as of 22.10.2025).

Local Representation (The "Applicant")

A foreign manufacturer cannot directly submit a registration dossier. You must appoint a local entity (the "Applicant") to manage the dossier and act as your legal representative. Furthermore, the Manufacturing Authorization Holder requires a local, 24/7 Qualified Person for Pharmacovigilance (QPPV) resident in Moldova. As your full-service partner, we provide both of these essential services.

This requirement for a local Applicant is a key mandate of the Law on Medicines No. 153/2025 and ensures a responsible entity is physically available to the AMDM for all compliance and official matters.

Contact Us, as we can assist you with this.

Post-Marketing Obligations

Gaining Marketing Authorization is the beginning, not the end, of your regulatory responsibilities. As the Marketing Authorization Holder, you are accountable for the product's entire lifecycle on the Moldovan market. The new legislation (Law No. 153/2025) solidifies these responsibilities, aligning them almost completely with EU standards.

Your local representative (the Applicant) manages the direct interactions with the AMDM, but the ultimate responsibility for compliance rests with you, the Manufacturing Authorization Holder.

Here are the most critical ongoing obligations:

A) Managing Dossier Changes (Variations)
You must ensure that the approved registration dossier is kept up-to-date with your latest manufacturing processes and scientific data. Any change to the approved dossier is a "variation" and must be filed with the AMDM.
The new law formally adopts the EU's classification system, a significant step that brings predictability for foreign manufacturers. Variations are now classified as:

Type IA/IB (Minor Variations / "Do and Tell"): These are for minor changes (e.g., an administrative change or a minor update to a manufacturing process) that have minimal or no impact on the product's quality, safety, or efficacy. These are typically submitted via a notification procedure.
Type II (Major Variations): These are major changes that could have an impact on the product (e.g., a change in the drug substance manufacturer or an update to the SmPC based on new efficacy data). These require a formal approval from the AMDM before implementation.

What this means for you: Your internal change control processes must account for the Moldovan registration. Any change you make globally must be evaluated for its impact on the Moldovan dossier and filed with the AMDM by your local partner according to this new EU-aligned framework.

Warning: A pharmaceutical arriving at Moldova's National Control Laboratory for testing with a Certificate of Analysis with a modified specification, that was not approved by AMDM, leads to suspension of the Marketing Authorization until the relevant variation for the change of the specification is filed and approved by AMDM.

B) Pharmacovigilance and Safety Reporting

This is one of the most serious post-marketing obligations. As the Manufacturing Authorization Holder, you are solely responsible for monitoring the safety of your product. Key requirements include:

Pharmacovigilance System Master File (PSMF): You must maintain a PSMF, just as you do for the EU, and make it available to the AMDM upon request.
Periodic Safety Update Reports (PSURs): You must submit PSURs to the AMDM. The schedule and content requirements are aligned with EU Good Pharmacovigilance Practice (GVP).
Local QPPV: You must appoint a qualified person responsible for pharmacovigilance (QPPV) who is resident in the Republic of Moldova and available 24/7.
Adverse Event Reporting: You must ensure that all adverse drug reactions (ADRs) reported in Moldova are collected, assessed, and transmitted to the AMDM within the legally required timelines.
Mandatory PV activity fees: The legal framework establishes a clear fee structure for pharmacovigilance activities. As the Manufacturing Authorization Holder, you must budget for these compliance costs, which (as of 2025) include fees for:
- Evaluation of Periodic Safety Update Reports (PSURs).
- Evaluation of Risk Management Plans (RMPs).
- Assessment of post-authorization safety studies (PASS).

C) Notification of Supply Interruption

A critical aspect of the new legislation is the obligation to ensure continuity of supply. As the Manufacturing Authorization Holder, you have a legal duty to inform the authorities of any potential supply issues.

You must formally notify the AMDM (and, in practice, your local distributor) of any temporary or permanent interruption in the supply of your medicine to the Moldovan market.

This notification must be made at least two months in advance, allowing the health system to prepare and seek alternatives. This is a standard requirement in the EU (under Article 23a of Directive 2001/83/EC) and is now a firm obligation in Moldova.

D) Labeling and Packaging

You must ensure that the packaging (labeling, leaflet) of commercial batches exported to Moldova are fully compliant with the packaging that was approved by the AMDM as part of your marketing authorization. Any deviation or update to the packaging (which would be a "variation") must be approved before the new packaging is imported.

Aligning with the EU's Falsified Medicines Directive (FMD), Law 153/2023 mandates that prescription-only medicines must have safety features on their outer packaging, aligning with the EU's Falsified Medicines Directive. This includes:

A Unique Identifier (UI): A 2D data matrix code to allow for verification of authenticity.
An Anti-Tampering Device (ATD): A seal or other feature to show whether the package has been opened.

E) Suspension/revocation of Marketing Authorization by AMDM

As the Manufacturing Authorization Holder, you are responsible for all aspects of the product on the market. The AMDM has the legal authority, granted by Law 153/2023, to suspend or revoke your Marketing Authorization if the product or the Manufacturing Authorization Holder is found to be non-compliant.

While the warning about mismatched specifications is a perfect practical example, formal grounds for suspension or revocation include:

The product is found to be harmful.
The product lacks therapeutic efficacy.
The risk-benefit balance is no longer favorable.
The qualitative or quantitative composition does not match what was authorized.
Critical non-compliance with pharmacovigilance or manufacturing (GMP) obligations.

This underscores the importance of a diligent local partner to manage all post-marketing compliance.

Contact Us, as we can assist you with this.

Importation Logistics: From Your Factory to the Patient

Once your product has its Marketing Authorization and registered price, the physical importation begins. This is not a simple "ship-to-border" process. As your licensed importer, we manage these critical steps:

Import License: We hold the necessary licenses from the AMDM to legally import pharmaceutical products.
Batch-by-Batch Quality Control: Every single batch that arrives in Moldova is subject to control. This includes a full documentary review upon arrival. Thanks to Moldova's adherence to PIC/S and EU-GMP standards, products with a recognized GMP certificate and batch release certificate from an EU/PIC/S-qualified person can often be released without redundant local lab testing, saving time and money.
GDP-Compliant Supply Chain: From the moment your product enters our control, it is managed under strict EU Good Distribution Practices (GDP). Our state-of-the-art, temperature-controlled warehousing and validated cold-chain logistics ensure your product's integrity and quality are protected all the way to the pharmacy or hospital.

Recent Developments and Future Outlook

Moldova's regulatory framework is not static. Continuous efforts are being made to:

Government priority for the pharmaceutical industry: The pharmaceutical industry (together with 5 other industries) is designated as a priority sector for Moldova's economic development by 2030. The EU has launched a Call for Expressions of Interest for EU/EEA/Moldova-based businesses to invest in the Republic of Moldova's strategic sectors, including Health. Projects must have a minimum total size of €10 million and require the investor to provide at least 15% own equity. The remaining funding is supported by the EU and partner financial institutions through tools like financial guarantees and favourable loans up to 85%.
Further harmonize with EU legislation: This includes adopting new EU directives and guidelines as they emerge.
Digitalize processes: Development and implementation of Electronic Health Records for 90% of citizens by 2030, full digitalisation of medicines prescription and others.
Strengthen market surveillance: There is a plan to implement a mechanism for full-scale pharmaceutical track and trace system (serialization) to monitor medicines from import to pharmacy.
By the end of 2025, in the beginning of 2026 new legislation will be approved, overhauling the legal basis for activity of pharmacies, and the registration process for pharmaceuticals.

Conclusion

The Moldovan pharmaceutical market, while requiring careful navigation of its regulatory landscape, offers significant potential for foreign companies. The ongoing harmonization with EU standards provides a familiar framework for many international players. However, successful entry and operation necessitate a thorough understanding of local requirements and a reliable local partner.

As experienced pharmaceutical importers and distributors in Moldova, we are not just well-versed in these regulations—we manage them daily. Our ISO 9001:2015 certification assures you of a meticulous, quality-controlled, and transparent partnership from day one. We are committed to facilitating a smooth and compliant market entry for our partners, with a proven track record in regulatory affairs, market access, and GDP-compliant logistics that ensures your product's compliance and commercial success.

Disclaimer: This guide provides a general overview and should not be considered legal advice. This guide is a high-level overview. For a specific assessment of your product's potential and a tailored regulatory and market-access strategy, we invite you to contact our expert team. In case of any corrections required in this material, please get in touch with us using the contact form on the page Contact Us.

References

Last modified: 30.10.2025

A Manufacturer’s Guide to Moldova’s Pharma Market: 2025 Regulations & Statistics

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