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
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
Certificates of a Pharmaceutical Product (CPP)Finnish Medicines Agency Fimea
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. - 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
Exceptional permits for medicinal productsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceExceptional permit for 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 serviceFimeaWeb is a free search service for medicinal products, where one can search for information on products intended for humans and animals. - 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
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
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
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 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
Notification on a suspected adverse reaction to a medicinal product/vaccineFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceReporting a suspected adverse reaction to a medicinal product/vaccine to the authority’s monitoring system. - 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 a clinical trial on pharmaceuticalsFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceUnder section 87 of the Medicines Act, prior notice of clinical (intervention) trials with humans to Fimea is required. - 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
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
Requests for informationFinnish Medicines Agency Fimea
ServiceNationwidePublic serviceFimea registry will reply to questions and document request regarding registered documents. - 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
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. - Finnish Medicines Agency Fimea
Sustainment of sales permit or registrationFinnish Medicines Agency Fimea
Permit or other obligationNationwidePublic serviceVariation or renewal of a sales permit, transfer of a sales permit or registration to a new holder
Information on all services is not available in your chosen language. Change the language of the site to receive information on services in other languages.
See more service channels by this organization
Fimea Secure Mail
E-serviceNationwideInstructions for using the Fimea Security Mail ServiceMeds75+
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/vaccine
Adverse effects notification form / veterinary medicinal product or vaccine
FormNationwideNotification form for suspected adverse effects to veterinary medicinal products/vaccinesMeds75+
FormNationwideDatabase of medication for elderly in PDF formatProduct defects /Form
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)
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)
Additional information to be submitted with narcotics licence applications
WebsiteNationwideApplications for a licence to import, export, produce or handle narcotic drugs can be submitted using a free-format application.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 dispensariesApplications 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 (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 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
WebsiteNationwideThis 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 monitoringInformal Regulatory Guidance
WebsiteNationwideThe Finnish Medicines Agency Fimea provides, at a case-by-case decision, Informal Regulatory Guidance at an early stage of drug development for clientKnow 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 medicinesMarketing authorisation procedures (veterinary medicines)
WebsiteNationwideAll veterinary medicines used in Finland must be granted marketing authorisation by the Finnish Medicines Agency FimeaMarketing 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 purposesPrior 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 productsSummaries of product characteristics and package leaflets
WebsiteNationwideFurther information on summaries of product characteristics and package leafletsSunset 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:
E204503
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