Finnish Medicines Agency Fimea
Organisation
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?
- Finnish Medicines Agency Fimea
Applications and notifications related to performance studies of IVD devicesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceThe sponsor of a performance study shall enter and submit an application to Fimea if the study is to be conducted in Finland. - Finnish Medicines Agency Fimea
Applying for a GMP certificateFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceFimea issues GMP certificates to Finnish medicinal product manufacturers and competent authorities of export countries for medicinal product exports. - Finnish Medicines Agency Fimea
Applying for an exemption to place a medical device on the marketFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceFimea may grant a temporary derogation for the placing on the market or putting into service of a medical device. - Finnish Medicines Agency Fimea
Applying for authorization for a clinical investigation with medical devicesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceAll clinical investigations with medical devices under the MD Regulation must be notified to Fimea or be subject to an authorization request. - Finnish Medicines Agency Fimea
Base register of drug productsFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe base register of drug products is a register maintained by Fimea concerning licenced drugs and fixed-term products under a special licence. - Finnish Medicines Agency Fimea
Batch-specific controlFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceBatch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines - Finnish Medicines Agency Fimea
Certificate of free saleFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceUpon request, Fimea issues certificates of free sale for medical devices that have been notified to Fimea in the CERE register or to Eudamed. - Finnish Medicines Agency Fimea
Certificates of a Pharmaceutical Product (CPP)Finnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceFimea issues marketing authorisation holders with Certificates of a Pharmaceutical Product for export purposes. - Finnish Medicines Agency Fimea
Classification decisionFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe classification decision is based on an assessment of the effect and presentation of the product. - Finnish Medicines Agency Fimea
Exemptions for medicinal productsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceExemption for medicinal product with marketing authorisation/registration critical to Finnish pharmaceutical service, involving risk of interruption. - Finnish Medicines Agency Fimea
Export certificates for pharmaceutical factories and wholesalesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceCertificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product - Finnish Medicines Agency Fimea
FimeaWebFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceFimea’s databases contain information on both human and veterinary medicines and on their rational use. - Finnish Medicines Agency Fimea
Good Laboratory Practice (GLP)Finnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceGood Laboratory Practice (GLP) is a quality system - Finnish Medicines Agency Fimea
Import and export licences for narcotic drugsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceImport and export licences for substances or preparations (pharmaceutical preparation) qualified as narcotic drugs. - Finnish Medicines Agency Fimea
Informal Regulatory GuidanceFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceInformal Regulatory Guidance provides information on regulatory instructions related to drug development - Finnish Medicines Agency Fimea
Know your medicine - Facebook pageFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceA channel maintained by pharmaceutical sector operators and patient organisations for finding reliable pharmaceutical information on social media. - Finnish Medicines Agency Fimea
Licences relating to industrial production of pharmaceuticalsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceLicences relating to industrial production of pharmaceuticals are pharmaceutical plant, contract manufacturing, and contract analysing licence. - Finnish Medicines Agency Fimea
Maintenance of marketing authorization or registrationFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceAfter a marketing authorisation has been granted, the holder of a marketing authorisation is obliged to actively maintain the marketing authorisation. - Finnish Medicines Agency Fimea
Marketing authorisations and registrations of medicinal productsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceAll medicinal, veterinary medicinal and herbal medicinal products sold in Finland require a marketing authorisation from Fimea or the EMA. - Finnish Medicines Agency Fimea
Medical Device Advisory ClinicFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceFimea offers free advice on planned clinical investigations with medical devices in Finland. - Finnish Medicines Agency Fimea
Medical device manufacturer's incident reportFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceMedical device manufacturers must report incidents, and the procedure depends on the event and the applicable legislation. - Finnish Medicines Agency Fimea
Medical device operator and device registrationsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceBefore selling or placing a device on the market, the operator must notify Fimea of its operations and devices in the CERE or EUDAMED register. - Finnish Medicines Agency Fimea
Medicinal product manufacturer's licenceFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceLicence under the Medicines Act (395/1987) for pharmaceutical manufacturers and wholesale distributors operating in Finland. - Finnish Medicines Agency Fimea
Medicinal product wholesale dealer's licenceFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceWholesale trade in medicinal products is a subject to a licence issued by Fimea. - Finnish Medicines Agency Fimea
Medicine shortages searchFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceInformation submitted by pharmaceutical companies on shortages and their duration is published in the shortage search. - Finnish Medicines Agency Fimea
Medicines Education PortalFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe Medicines Education Portal is an info package on the use of medicines. It contains study modules and task ideas for basic education teachers. - Finnish Medicines Agency Fimea
Meds75+ databaseFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe database contains classifications and recommendations for almost 500 medicinal substances or their combinations when used by elderly. - Finnish Medicines Agency Fimea
Notification of a clinical investigation with medical devicesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceAll clinical investigations with medical devices under the MD Regulation must be notified to Fimea or be subject to an authorization request. - Finnish Medicines Agency Fimea
Notification of interruption or discontinuation of the supply of a medical deviceFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceThe manufacturer of a medical device must give notice of an anticipated interruption or discontinuation of the device it manufactures. - Finnish Medicines Agency Fimea
Notification of suspected adverse reactions to veterinary medicinal productsFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe safety of veterinary medicinal products authorised for sale is monitored, for example, by means of adverse reaction notifications on their use. - Finnish Medicines Agency Fimea
Opinions on devices under special procedure for notified bodiesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceNotified body must seek Fimea’s opinion if EMA opinion is not required. - Finnish Medicines Agency Fimea
Preparation fault reportFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic servicePreparation fault must be reported to Fimea that will ensure that the corrective measures are adequate and sufficient. - Finnish Medicines Agency Fimea
Prior notice of clinical veterinary drug researchFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceUnder section 88a of the Medicines Act, prior notice of clinical trials with veterinary drugs to Fimea is required. - Finnish Medicines Agency Fimea
Registration to the NIS2 Entity ListFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceRegistration to the NIS2 entity list for operators supervised by Fimea. - Finnish Medicines Agency Fimea
Reports of adverse blood products reactions and risky situationsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceAdverse reactions and risky situations observed in the transfusion, quality or safety of blood products shall be reported to Fimea. - Finnish Medicines Agency Fimea
Scientific advice on medicinal productsFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceScientific advice is provided on the documentation of the quality, efficacy and safety of a medicinal product for human or veterinary use. - Finnish Medicines Agency Fimea
Shortage notificationsFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceThe marketing authorization holder can report a medicine availability disruption to Fimea electronically. - Finnish Medicines Agency Fimea
Supervising blood servicesFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceFimea directs and supervises blood services in Finland and collaborates with the relevant international authorities. - Finnish Medicines Agency Fimea
Supervising tissue establishmentsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceFimea directs and supervises the activities of tissue establishments in Finland and collaborates with the relevant international authorities. - Finnish Medicines Agency Fimea
Supervision of organ activityFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceOrgan transplant activity is supervised in Finland by Fimea, Valvira and the Regional State Administrative Agencies.
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See more service channels by this organization
Device and operator notifications to CERE
E-serviceNationwideCERE is a national register of medical device operators and their devices maintained by Fimea.E-service for shortage notifications
E-serviceNationwideThe marketing authorization holder can electronically report a medicine availability disruption to Fimea.Electronic service for special permits
E-serviceNationwideThrough the electronic service for special permits, you can apply to Fimea for a special permit for a medicinal product.Fimea Secure Mail
E-serviceNationwideInstructions for using the Fimea Security Mail ServiceFimea's e-service
E-serviceNationwideThrough e-service, you can access Fimea's servicesMeds75+
E-serviceNationwideSearch service for medication for elderlyNotification on a suspected adverse reaction to a veterinary product/vaccine
E-serviceNationwideElectronic notification on a suspected adverse reaction to a veterinary product/vaccineRequesting an opinion, devices with a special additional procedure
E-serviceNationwideAs part of the conformity assessment process, the notified body must request an opinion from the competent pharmaceutical authority.Requests for Medical Device Advisory Clinic
E-serviceNationwideRequests for Medical Device Advisory Clinic and other inquiries should be sent by e-mail to: cie@fimea.fi.
Adverse effects notification form / veterinary medicinal product or vaccine
Printable formNationwideNotification form for suspected adverse effects to veterinary medicinal products/vaccinesApplication for an exemption for placing a medical device on the market or putting one into service
Printable formNationwideThe derogation is applied for by using Fimeas application form or with a free-form application.Application form for clinical investigations with medical devices
Printable formNationwideThe application form is used to apply for authorisation for clinical investigations conducted with medical devices under the MD RegulationManufacturer’s notification form for interruption or discontinuation of deliveries
Printable formNationwideThe manufacturer reports the information to the competent authority using the form MDCG 2024-16.Meds75+
Printable formNationwideDatabase of medication for elderly in PDF formatProduct defects /Form
Printable formNationwideThe Product defect Form for Medicinal Products shall be filled out and sent to Fimea by email at: tuotevirheet@fimea.fiSpecial permission application for compassionate use (veterinary medicines)
Printable formNationwideApplication can be made by a veterinarian or a bachelor of veterinary medicine as a substitute veterinarian.
Customer service of the registry office
Telephone serviceNationwideCustomer service of Fimea's registry officeMonday-Friday 9.00–15.00Telephone:+358 295223602(local/mobile network fee)
Application for a pharmaceutical wholesale license
WebsiteNationwideMore information of application for a pharmaceutical wholesaleApplication for authorisation regarding pharmacy activities
WebsiteNationwideFimea issues licences for pharmacies, hospital pharmacies and dispensariesApplication for modification of a pharmaceutical manufacturing license
WebsiteNationwidePharmaceutical manufacturers must apply to Fimea in advance to amend or expand their manufacturing authorisation (Medicines Decree, Section 1).Applications for a licence to produce or handle narcotic drugs
WebsiteNationwideApplications for a licence to import, export, produce or handle narcotic drugs can be submitted using a free-format application.Applying for classification
WebsiteNationwideInstructions for applying for classificationBasic register
WebsiteNationwideThe basic register for medicinal products is a register maintained by FimeaBatch-specific control
WebsiteNationwideBatch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccinesCertificate of a pharmaceutical product
WebsiteNationwideFimea issues marketing authorisation holders with Certificates of a Pharmaceutical Product for export purposes.Certificates of a Pharmaceutical Product (CPP)
WebsiteNationwideForm and instructions for applying for an export certificates of pharmaceutical plants and wholesalesClinical trials on veterinary medicinal products
WebsiteNationwideA clinical trial of a veterinary medicinal product refers to a study of the effect of a veterinary medicinal product on a target animal speciesContact form for Fimea’s registry
WebsiteNationwideA contact form to be completed and sent online to Fimea’s registryExemption for medicinal products
WebsiteNationwideAdditional information on exceptional permits for medicinal productsFimeaWeb
WebsiteNationwideFimea’s databases contain information on both human and veterinary medicines and on their rational use.Good Laboratory Practice (GLP)
WebsiteNationwideContact details for GLP compliance monitoringIncident report
WebsiteNationwideThe page describes the medical device manufacturer’s incident reporting procedure and the deadlines for submitting reports to the authorities.Informal Regulatory Guidance
WebsiteNationwideFimea provides, at a case-by-case decision, Informal Regulatory Guidance at an early stage of drug development.Instructions for applying for a certificate of free sale
WebsiteNationwideA webpage containing instructions for applying for a certificate of free sale and an email address.Instructions for applying for a GMP certificate
WebsiteNationwideA web page containing instructions for applying for a GMP certificate and the email address.Know your medicine
WebsiteNationwideA channel maintained by pharmaceutical sector operators and patient organisations for finding reliable pharmaceutical information on social media.Mandatory reserve supplies
WebsiteNationwideThe purpose of legislation concerning mandatory reserve medical supplies is to ensure the availability of medicinesManufacturing license for a pharmaceutical company
WebsiteNationwideThe manufacturing licence can be applied for from Fimea by submitting a free-form licence pplication to Fimea's registrar's office.Marketing Authorisations
WebsiteNationwideA medicinal product must have a marketing authorisation before it can be introduced to marketNarcotics control
WebsiteNationwideFimea grants licences to import, export, produce and handle narcotic drugs for medicinal, scientific and research purposesPerformance studies of IVD-devices
WebsiteNationwideAn application or notification to Fimea is required for IVD performance studies in Finland.Prior notice of a clinical trial
WebsiteNationwideInformation on prior notice of clinical trialsRenewals and variation applications
WebsiteNationwideThe holder of a marketing authorisation or registration is obliged to actively maintain the marketing authorisation or registration.Scientific advice
WebsiteNationwideFimea provides, at a case-by-case decision, scientific advice on the quality, efficacy and safety documentation of medicinal products.Shortages
WebsiteNationwideOn the medicine shortages website, the information reported by the pharmaceutical company about the medicine shortage is published.Summaries of product characteristics and package leaflets
WebsiteNationwideMore information about summaries of product characteristics and package leaflets.Sunset clause exemption
WebsiteNationwideSunset clause exemption. Fimea may decide that a marketing authorisation or registration will not expire after the set period of three years.Supervising blood services
WebsiteNationwideFimea directs and supervises blood services in Finland and collaborates with the relevant international authoritiesSupervising tissue establishments
WebsiteNationwideFimea directs and supervises the activities of tissue establishments in Finland and collaborates with the relevant international authorities.Sustainment of marketing authorisations for veterinary medicines
WebsiteNationwideAdditional information about the sustainment of sales permits for veterinary drugs
Information on all service channels is not available in your chosen language. Change the language of the site to receive information on service channels in other languages.
Registry Office
registry@fimea.fi
Address
Mannerheimintie 166
00300 Helsinki
Address
Microkatu 1
70210 Kuopio
Address
Itsenäisyydenaukio 2
20800 Turku
Address
Biokatu 10
33520 Tampere
Address
Aapistie 1
90220 Oulu
Organisation identification data
Business ID: 0921536-6
Electronic invoicing details
Electronic invoicing address (EDI code):003709215366
Intermediator code:
FI28768767
Telephone number
Registry Office
+358 295223602
(local/mobile network fee)
Website
Finnish Medicines Agency Fimea
www.fimea.fi/web/en/frontpageOpens in a new window.
Postal address
P.O. Box 55
00034 Fimea