FiMVO Finnish Medicines Verification Organisation

What FiMVO Finnish Medicines Verification Organisation does

FiMVO Finnish Medicines Verification Organisation (legal name Suomen Lääkevarmennus Oy) is a Finnish non-profit company founded in December 2016 to operate Finland's national medicines verification system in compliance with the EU Falsified Medicines Directive (Delegated Regulation 2016/161). It is owned by six Finnish pharmaceutical industry stakeholders: Lääketeollisuus ry (Pharma Industry Finland), Orion Oyj, Rinnakkaislääketeollisuus ry (Generic Pharmaceutical Industry), Suomen Lääkerinnakkaistuojat ry (Parallel Importers), Suomen Apteekkariliitto ry (Finnish Pharmacy Association), and Lääke- ja Terveyshuolto. The organization operates the Finnish Medicines Verification System (FiMVS), launched on 9 February 2019, which verifies unique identifiers on every medicine package dispensed in the Finnish supply chain to prevent counterfeit medicines from reaching patients. The system is interconnected with the European Medicines Verification System (EMVS) via the EU Hub managed by EMVO, enabling cross-border data exchange across EU member states.

The core technology consists of three components: (1) the FiMVS production environment (currently at Core version 1.11, deployed October 2022), which serves as the national node for verification queries and master data; (2) the NMVS User Portal, a browser-based platform for managing organization credentials, facility data, and IT system connections via interface version 5; and (3) the Alert Handling System, which manages verification failure alerts using standardized error codes with documentation in Finnish, Swedish, and English. The underlying infrastructure is provided by Solidsoft Reply Ltd as core technology partner, with Microsoft providing cloud/data processing infrastructure and Visma providing electronic contract signing (Visma Sign) and invoicing. Operations are run by a 7-person team comprising the CEO (Maija Gohlke), Finance and Administration Manager, Quality Manager, IT Manager, Administration and Communications Coordinator, and Customer Service Manager.

FiMVO's business model is subscription-based and non-profit. Revenue is generated through annual fees from marketing authorization holders (pharmaceutical companies placing products on the Finnish market) and user fees from pharmacies, hospital pharmacies, and medicine wholesalers who are legally required to connect to FiMVS to operate in Finland. The go-to-market is enterprise/field-based direct engagement with mandatory participants; pricing is not publicly disclosed. FiMVO uses digital marketing channels (website, LinkedIn, Instagram, bi-annual newsletters) and runs training sessions, webinars, and educational content for pharmacies, wholesalers, IT partners, and pharmacy students. The company is headquartered at c/o Lääketeollisuus ry, Itämerentori 2, 00180 Helsinki.

Name

FiMVO Finnish Medicines Verification Organisation

Legal name

Suomen Lääkevarmennus Oy

Website

https://laakevarmennus.fi

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

FiMVO (Suomen Lääkevarmennus Oy) is a Finnish non-profit operating the national FiMVS medicines verification system mandated by EU regulation, serving pharmacies, wholesalers, and pharmaceutical companies to prevent counterfeit medicines from reaching patients.

Ownership category

akta.pro rank

Product category

Pharmaceutical Verification Systems

NAICS

Testing Laboratories and Services (54138)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

Keywords

• Pharmaceutical verification
• Medicines traceability
• Counterfeit prevention
• Pharmaceutical supply chain
• Regulatory compliance systems

Headquarters

HQ city

Helsinki

HQ country

Finland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Annual fees from marketing authorization holders: Non-profit organization that generates revenue through annual fees charged to pharmaceutical companies (marketing authorization holders) for system access and maintenance.
2. User fees from pharmacies and wholesalers: Organizations using the system (pharmacies, hospital pharmacies, medicine wholesalers) pay fees for system access and usage.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

FiMVO operates the Finnish Medicines Verification System (FiMVS), a regulatory compliance platform mandated by EU Directive 2011/62/EU that verifies the authenticity of medicinal packages in the Finnish pharmaceutical supply chain. The system connects to the European Medicines Verification System (EMVS) via the EU Hub for cross-border verification, and includes a web-based NMVS User Portal for organization and user management, plus an Alert Handling System for verification failures.

Product overview

FiMVO operates the Finnish Medicines Verification System (FiMVS), a regulatory compliance platform for pharmaceutical traceability mandated by EU Directive 2011/62/EU. The system consists of the FiMVS production environment (Core version, currently at 1.11 as of October 2022), a browser-based NMVS User Portal for organization and user management, and an Alert Handling System for managing verification failures. The FiMVS is part of the pan-European European Medicines Verification System (EMVS), with the EU Hub as the central database. Organizations connect their pharmacy, hospital, or wholesaler IT systems through the NMVS portal using interface version 5.

Differentiator

Problem solved

Functional benefit

Products and services

• FiMVS (Finnish Medicines Verification System) National medicines verification system that verifies the authenticity of medicinal packages in the Finnish pharmaceutical supply chain, preventing counterfeit medicines from reaching patients through pharmacies and hospitals. Connects to the European Medicines Verification System via the EU Hub for cross-border data exchange.
• NMVS User Portal Web-based browser portal for managing organization data, facility management, user accounts, and credentials for connecting IT systems of pharmacies, hospital pharmacies, and wholesalers to the medicines verification system.
• Alert Handling System System component that manages and processes alerts generated when medicines verification fails, including error codes NMVS_NC_PCK_06, NMVS_NC_PCK_19, and NMVS_NC_PCK_27, with handling guidelines available in Finnish, Swedish, and English.

Quantifiable outcome

• Effective counterfeit prevention in Finnish pharmaceutical supply chain
• +1 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature2 records

Partnerships

Ten partnerships are on record, tiered core and supporting.

• EMVO (European Medicines Verification Organisation)coreTechnology or IntegrationEMVO manages the European Medicines Verification System (EMVS) and the EU Hub, which connects all national medicines verification systems across EU member states. FiMVO is an active participant in EMVO activities and its CEO serves as an observer on EMVO's board.
• Solidsoft Reply LtdcoreTechnology or IntegrationTechnology partner providing the underlying medicines verification system infrastructure. Mirka Koski, FiMVO's IT Manager, works closely with Solidsoft Reply to ensure system functionality.
• VismacoreTechnology or IntegrationSoftware provider used for electronic contract signing (Visma Sign) and potentially other internal systems.
• MicrosoftsupportingTechnology or IntegrationTechnology infrastructure provider for data processing and storage.
• Lääketeollisuus ry (Pharma Industry Finland)coreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO. Represents pharmaceutical companies in Finland.
• Orion OyjcoreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO. Major Finnish pharmaceutical company.
• Rinnakkaislääketeollisuus ry (Generic Medicines Industry Finland)coreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO. Represents generic pharmaceutical companies.
• Suomen Lääkerinnakkaistuojat ry (Finnish Parallel Importers Association)coreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO. Represents parallel medicine importers.
• Suomen Apteekkariliitto ry (Finnish Pharmacy Association)coreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO. Represents Finnish private pharmacies.
• Lääke- ja TerveyshuoltocoreStrategic or Co-development PartnerOne of the six owners/operators of FiMVO.

Scale indicators2 records

Recent moves6 records

Expansion highlights3 records

Direct peers

• France MVO: France MVO runs France's national medicines verification system, delivering FMD-compliant authentication and serialization services structurally identical to FiMVO's FiMVS. Same mandate, same stakeholder ecosystem, same non-profit governance model.
• BeMVO (Belgian Medicines Verification Organisation): BeMVO runs Belgium's national medicines verification system, fulfilling the same FMD mandate as FiMVO. Direct peer with comparable structure, fee model, and stakeholder ecosystem for pharmacies, wholesalers, and MAHs.
• European Medicines Verification Organisation (EMVO): EMVO operates the pan-European Medicines Verification System (EMVS) and the EU Hub that connects every national medicines verification system, including FiMVO. It is the closest functional peer — the European-level counterpart to FiMVO's national FiMVS, with an identical regulatory mandate.
• Stichting NMVO: Stichting NMVO operates the Dutch national medicines verification system under the same EU directive. Direct peer in mandate, system architecture, fee model, and multi-stakeholder ownership structure.
• securPharm e.V. securPharm operates Germany's national medicines verification system under the same EU Falsified Medicines Directive framework as FiMVO. Direct peer serving pharmacies, wholesalers, and MAHs with the same FMD-mandated authentication architecture.
• Medicines Verification Programme Ireland (IMVO): IMVO operates Ireland's national medicines verification system, delivering equivalent FMD-compliant authentication and serialization services as FiMVO. Direct peer serving a similar pharmacy, wholesaler, and MAH stakeholder set.

Others

• Arvato Systems: Arvato Systems provides pharmaceutical serialization and track-and-trace solutions to manufacturers and supply chain participants. It is an adjacent technology provider within the same medicines verification ecosystem FiMVO operates in.
• TraceLink: TraceLink provides pharmaceutical supply chain serialization and traceability platforms to MAHs and supply chain participants globally. It sits in the same medicines verification ecosystem, serving many of the same manufacturers FiMVO serves via FiMVS.
• Solidsoft Reply: Solidsoft Reply is FiMVO's core technology partner, supplying the underlying medicines verification platform used by multiple national MVOs across Europe. Adjacent ecosystem participant — not a competitor, but the technology backbone that powers FiMVS.
• SAP (Advanced Track and Trace for Pharma): SAP's ATTP platform provides serialization, authentication, and traceability software used by pharmaceutical manufacturers and supply chain participants across Europe. It operates as an enabling technology layer comparable to the FiMVS system.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/fimvo-finnish-medicines-verification-organisation
• Instagraminstagram.com/fimvo.suomenlaakevarmennus

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FiMVO Finnish Medicines Verification Organisation