Finnish Medicines Agency Fimea
Alternative name Fimea
The Finnish Medicines Agency Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population by regulating medicinal, blood and tissue products, and by developing the pharmaceuticals sector.
What services can I get?
Base register of drug productsServiceNationwidePublic serviceThe base register of drug products is a register maintained by Fimea concerning licenced drugs and fixed-term products under a special licence.
Batch-specific controlPermit or other obligationNationwidePublic serviceBatch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines
Certificates of a Pharmaceutical Product (CPP)Permit or other obligationNationwidePublic serviceWhen a pharmaceutical factory exports medicines (usually outside the EU/EEA), a certificate of a pharmaceutical product issued by Fimea is required.
Classification decisionServiceNationwidePublic serviceThe classification decision is based on an assessment of the effect and presentation of the product.
Exceptional permits for medicinal productsPermit or other obligationNationwidePublic serviceExceptional permit for product with marketing authorisation/registration critical to Finnish pharmaceutical service, involving risk of interruption.
Export certificates for pharmaceutical factories and wholesalesPermit or other obligationNationwidePublic serviceCertificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product
FimeaWebServiceNationwidePublic serviceFimeaWeb is a free search service for medicinal products, where one can search for information on products intended for humans and animals.
Good Laboratory Practice (GLP)Permit or other obligationNationwidePublic serviceGood Laboratory Practice (GLP) is a quality system
Import and export licences for narcotic drugsPermit or other obligationNationwidePublic serviceImport and export licences for substances or preparations (pharmaceutical preparation) qualified as narcotic drugs.
Informal Regulatory GuidanceServiceNationwidePublic serviceInformal Regulatory Guidance provides information on regulatory instructions related to drug development
Know your medicine - Facebook pagePermit or other obligationNationwidePublic serviceA channel maintained by pharmaceutical sector operators and patient organisations for finding reliable pharmaceutical information on social media.
Licences relating to industrial production of pharmaceuticalsPermit or other obligationNationwidePublic serviceLicences relating to industrial production of pharmaceuticals are pharmaceutical plant, contract manufacturing, and contract analysing licence.
Marketing authorisations and registrations of medicinal productsPermit or other obligationNationwidePublic serviceAll medicinal, veterinary medicinal and herbal medicinal products sold in Finland require a marketing authorisation from Fimea or the EMA.
Medicinal product wholesale dealer's licencePermit or other obligationNationwidePublic serviceWholesale trade in medicinal products is a subject to a licence issued by Fimea.
Medicines Education PortalServiceNationwidePublic serviceThe Medicines Education Portal is an info package on the use of medicines. It contains study modules and task ideas for basic education teachers.
Meds75+ databaseServiceNationwidePublic serviceThe database contains classifications and recommendations for almost 500 medicinal substances or their combinations when used by elderly.
Notification of suspected adverse reactions to veterinary medicinal productsServiceNationwidePublic serviceThe safety of veterinary medicinal products authorised for sale is monitored, for example, by means of adverse reaction notifications on their use.
Notification on a suspected adverse reaction to a medicinal product/vaccineServiceNationwidePublic serviceReporting a suspected adverse reaction to a medicinal product/vaccine to the authority’s monitoring system.
Preparation fault reportPermit or other obligationNationwidePublic servicePreparation fault must be reported to Fimea that will ensure that the corrective measures are adequate and sufficient.
Prior notice of a clinical trial on pharmaceuticalsPermit or other obligationNationwidePublic serviceUnder section 87 of the Medicines Act, prior notice of clinical (intervention) trials with humans to Fimea is required.
Prior notice of clinical veterinary drug researchPermit or other obligationNationwidePublic serviceUnder section 88a of the Medicines Act, prior notice of clinical trials with veterinary drugs to Fimea is required.
Reports of adverse blood products reactions and risky situationsPermit or other obligationNationwidePublic serviceAdverse reactions and risky situations observed in the transfusion, quality or safety of blood products shall be reported to Fimea.
Requests for informationServiceNationwidePublic serviceFimea registry will reply to questions and document request regarding registered documents.
Scientific advice on medicinal productsServiceNationwidePublic serviceScientific advice is provided on the documentation of the quality, efficacy and safety of a medicinal product for human or veterinary use.
Supervising blood servicesPermit or other obligationNationwidePublic serviceFimea directs and supervises blood services in Finland and collaborates with the relevant international authorities.
Supervising tissue establishmentsPermit or other obligationNationwidePublic serviceFimea directs and supervises the activities of tissue establishments in Finland and collaborates with the relevant international authorities.
Supervision of organ activityPermit or other obligationNationwidePublic serviceOrgan transplant activity is supervised in Finland by Fimea, Valvira and the Regional State Administrative Agencies.
Sustainment of sales permit or registrationPermit or other obligationNationwidePublic serviceVariation or renewal of a sales permit, transfer of a sales permit or registration to a new holder
See more service channels by this organization
Fimea Secure MailE-serviceNationwideInstructions for using the Fimea Security Mail Service
Meds75+E-serviceNationwideSearch service for medication for elderly
Notification on a suspected adverse reaction to a veterinary product/vaccineE-serviceNationwideElectronic notification on a suspected adverse reaction to a veterinary product/vaccine
Adverse effects notification form / veterinary medicinal product or vaccineFormNationwideNotification form for suspected adverse effects to veterinary medicinal products/vaccines
Meds75+FormNationwideDatabase of medication for elderly in PDF format
Product defects /FormFormNationwideThe Product defect Form for Medicinal Products shall be filled out and sent to Fimea by email at: email@example.com
Special permission application for compassionate use (veterinary medicines)FormNationwideApplication can be made by a veterinarian or a bachelor of veterinary medicine as a substitute veterinarian.
Customer service of the registry officeTelephone serviceNationwideCustomer service of Fimea's registry officeMonday-Friday 9.00–15.00Telephone:+358 295223602(local/mobile network fee)
Additional information to be submitted with narcotics licence applicationsWebsiteNationwideApplications for a licence to import, export, produce or handle narcotic drugs can be submitted using a free-format application.
Application for a pharmaceutical wholesale licenseWebsiteNationwideMore information of application for a pharmaceutical wholesale
Application for authorisation regarding pharmacy activitiesWebsiteNationwideFimea issues licences for pharmacies, hospital pharmacies and dispensaries
Applications for a licence to produce or handle narcotic drugsWebsiteNationwideApplications for a licence to import, export, produce or handle narcotic drugs can be submitted using a free-format application.
Applying for classificationWebsiteNationwideInstructions for applying for classification
Basic registerWebsiteNationwideThe basic register for medicinal products is a register maintained by Fimea
Batch-specific controlWebsiteNationwideBatch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines
Certificate of a pharmaceutical productWebsiteNationwideFimea issues marketing authorisation holders with Certificates of a Pharmaceutical Product (CPP) for export purposes (generally outside the EU/EEA).
Certificates of a Pharmaceutical Product (CPP)WebsiteNationwideForm and instructions for applying for an export certificates of pharmaceutical plants and wholesales
Clinical trials on veterinary medicinal productsWebsiteNationwideA clinical trial of a veterinary medicinal product refers to a study of the effect of a veterinary medicinal product on a target animal species
Contact form for Fimea’s registryWebsiteNationwideA contact form to be completed and sent online to Fimea’s registry
Exemption for medicinal productsWebsiteNationwideAdditional information on exceptional permits for medicinal products
FimeaWebWebsiteNationwideThis search form allows you to search for a specific medicine or drug, or create lists with the specific search criteria you want.
Good Laboratory Practice (GLP)WebsiteNationwideContact details for GLP compliance monitoring
Informal Regulatory GuidanceWebsiteNationwideThe Finnish Medicines Agency Fimea provides, at a case-by-case decision, Informal Regulatory Guidance at an early stage of drug development for client
Know your medicineWebsiteNationwideA channel maintained by pharmaceutical sector operators and patient organisations for finding reliable pharmaceutical information on social media.
Mandatory reserve suppliesWebsiteNationwideThe purpose of legislation concerning mandatory reserve medical supplies is to ensure the availability of medicines
Marketing authorisation procedures (veterinary medicines)WebsiteNationwideAll veterinary medicines used in Finland must be granted marketing authorisation by the Finnish Medicines Agency Fimea
Marketing AuthorisationsWebsiteNationwideA medicinal product must have a marketing authorisation before it can be introduced to market
Narcotics controlWebsiteNationwideFimea grants licences to import, export, produce and handle narcotic drugs for medicinal, scientific and research purposes
Prior notice of a clinical trialWebsiteNationwideInformation on prior notice of clinical trials
Renewals and variation applicationsWebsiteNationwideThe holder of a marketing authorisation or registration is obliged to actively maintain the marketing authorisation or registration.
Scientific adviceWebsiteNationwideFimea provides, at a case-by-case decision, scientific advice on the quality, efficacy and safety documentation of medicinal products
Summaries of product characteristics and package leafletsWebsiteNationwideFurther information on summaries of product characteristics and package leaflets
Sunset clause exemptionWebsiteNationwideSunset clause exemption. Fimea may decide that a marketing authorisation or registration will not expire after the set period of three years.
Supervising blood servicesWebsiteNationwideFimea directs and supervises blood services in Finland and collaborates with the relevant international authorities
Supervising tissue establishmentsWebsiteNationwideFimea directs and supervises the activities of tissue establishments in Finland and collaborates with the relevant international authorities.
Sustainment of marketing authorisations for veterinary medicinesWebsiteNationwideAdditional information about the sustainment of sales permits for veterinary drugs
Organisation identification data
Business ID: 0921536-6
Electronic invoicing detailsElectronic invoicing address (EDI code):
Registry Office+358 295223602
(local/mobile network fee)
Finnish Medicines Agency Fimea
www.fimea.fi/web/en/frontpageOpens in a new window.
P.O. Box 55