Finnish Medicines Agency

Name

Finnish Medicines Agency

Legal name

Lääkealan turvallisuus- ja kehittämiskeskus

Website

https://fimea.fi

Company type

Private

Operating status

Operating

Headcount range

251–500 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

NAICS

Medical and Diagnostic Laboratories (62151)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Medical Device Regulators (HLAJADAC)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ), Conformity Assessment, Testing, Inspection & Certification Cooperation (BPADANAD)

Keywords

• Pharmaceutical regulation
• Medicines licensing
• Pharmacovigilance services
• Medical device oversight
• Pharmacy supervision

Headquarters

HQ city

Helsinki

HQ country

Finland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Distribution channels1 record

Marketing channels8 records

Core offering

Fimea is the national medicines regulatory authority of Finland, operating under the Ministry of Social Affairs and Health. It grants marketing authorisations for medicines and biological products, licenses and supervises pharmacies, oversees pharmaceutical manufacturers, monitors adverse effects, regulates medical devices, and operates an in-house Fimea Laboratory for pharmaceutical testing. It delivers these regulatory services through dedicated electronic portals and coordinates Finland's participation in EU and Nordic regulatory networks.

Product overview

The Finnish Medicines Agency (Fimea) is a regulatory authority under the Ministry of Social Affairs and Health, not a typical software company. Its core offering consists of regulatory and supervisory services organized into electronic service portals. The main platform架构 includes: Pharmacy Licensing Electronic Services for license applications, announcements, and management; ERKKA for special permits; Adverse Effect Reporting systems for both human and veterinary medicines; Medical Device (CERE) electronic services; NIS2 cybersecurity operator registry; Availability Disruption Notifications; and Pharmacy Operations management. These interconnected web-based systems require Suomi.fi authentication and are built on Microsoft Power Platform. The agency also provides public search tools for medicines and maintains pharmacy tax administration.

Differentiator

Problem solved

Functional benefit

Products and services

• Marketing Authorisation Services for Medicines Granting and maintenance of marketing authorisations for human and veterinary medicinal products, including new applications, variations, and renewals. Available to pharmaceutical companies seeking to market medicines in Finland.
• Pharmacy Licence Service Statutory licensing service for community pharmacies, hospital pharmacies, university pharmacies, and online pharmacies, including notifications of opening, changes, and closures. Available to pharmacy operators in Finland.
• ERKKA Electronic Service for Special Permits and Authorisations Electronic service portal for processing special permits and authorisations, including controlled substance licensing and other specific regulatory permissions. For pharmaceutical companies and pharmacy operators.
• CERE Medical Device Electronic Service Electronic service for medical device operators to register devices, place them on the Finnish market, and submit clinical investigation applications. For medical device manufacturers, importers, distributors, and authorised representatives.
• NIS2 Operator Registry Registration service for operators of essential services and critical infrastructure entities in the health sector as required under the EU NIS2 cybersecurity directive. For enterprises classified as essential or important entities.
• Availability Disruption Notification Service Electronic service for pharmaceutical companies to submit mandatory notifications when medicines are temporarily or permanently unavailable on the Finnish market.
• Adverse Effect Reporting Service Pharmacovigilance reporting channels for healthcare professionals and consumers to submit suspected adverse drug reactions, with feedback on reported cases.
• Fimea Laboratory Pharmaceutical Testing Services In-house laboratory service performing pharmaceutical, biological, and chemical testing of medicines and related products in support of regulatory supervision.
• Clinical Trial Approval Service Statutory service for processing and approving clinical trial applications on medicinal products in Finland, coordinating with ethics committees.
• Lääkehaku (Medicine Search) Public Database Public online database for searching authorised medicines in Finland, accessing package leaflets, summaries of product characteristics, and pricing information.

Quantifiable outcome

• Pharmacy sector reforms aim to reduce state pharmaceutical reimbursement spending by approximately 30 million euros per year and consumer costs by 6 million euros annually
• +2 more outcomes

Segments6 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature5 records

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Swedish Medical Products Agency (Läkemedelsverket): Sweden's national medicines and medical devices regulator, structurally analogous to Fimea: covers marketing authorization, pharmacy oversight, and adverse event reporting within a closely related Nordic jurisdiction with active bilateral cooperation.
• Norwegian Medicines Agency (Statens legemiddelverk): Norway's national medicines regulator under the Norwegian Ministry of Health, providing the closest cross-border functional analogue to Fimea via the Nordic cooperation framework and shared HTA/policy workstreams.
• Danish Medicines Agency (Lægemiddelstyrelsen): Denmark's national medicines and medical devices regulator, a direct Nordic counterpart with overlapping scope in pharmaceutical authorization, pharmacy supervision, and adverse event monitoring, frequently partnering with Fimea at EMA and on HTA joint work.

Broad incumbents

• Spanish Agency of Medicines and Medical Devices (AEMPS): Spain's national regulator for human and veterinary medicines and medical devices. AEMPS pairs the same marketing authorization, clinical trial oversight, and pharmacy licensing responsibilities as Fimea within a larger jurisdiction.
• European Medicines Agency (EMA): The EU-level medicines regulator that centralizes marketing authorization for many products. EMA coordinates the EU regulatory network of which Fimea is a member competent authority, and decisions at EMA directly flow into Fimea's scope of work.
• French National Agency for the Safety of Medicines (ANSM): France's national medicines and medical devices regulator covering marketing authorization, pharmacovigilance, and inspection, providing a comparable statutory structure to Fimea in a larger European market.
• UK Medicines and Healthcare products Regulatory Agency (MHRA): UK national regulator for medicines, medical devices, and blood products post-Brexit. Operates the same statutory model (marketing authorization, pharmacovigilance, medical device registration) as Fimea, making it a direct functional analogue in a larger market.
• German Federal Institute for Drugs and Medical Devices (BfArM): Germany's federal regulator covering drugs, medical devices, and biologics at scale comparable to Fimea's mandate but with a far larger jurisdiction. BfArM sets precedent on EU regulatory interpretation that Fimea adapts nationally.
• Italian Medicines Agency (AIFA): Italy's national regulator responsible for marketing authorization, pricing/reimbursement, and pharmacovigilance. AIFA shares the multi-stakeholder remit (industry, pharmacies, healthcare professionals) that defines Fimea's mandate.

Others

• EDQM (European Directorate for the Quality of Medicines & HealthCare): Council of Europe body that sets quality standards for medicines and operates the CEP/Certification procedure that Fimea references in national marketing authorizations. Acts as a standard-setting counterpart rather than direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/fimea
• Instagraminstagram.com/fimea.fi
• Xx.com/fimea

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 Finnish Medicines Agency