Skip to Content
Select search type
Page search
Medicine search
Search from site...
Search
Hakukenttä
Search
Move to advanced medicine search
Search
Close search
Menu
Kieliversion valinta
Valitse kieli
Suomi
Välj språket
Svenska
Select language
English
Contact Information
Close
Close
Kieliversion valinta
Valitse kieli
Suomi
Välj språket
Svenska
Select language
English
For public
What is a medicine?
Generic substitution
Generic products
Frequently asked questions
What is a biosimilar?
Frequently asked questions about biological drugs and biosimilars
What is a food supplement?
Safety of medicines
Monitoring the safety of medicinal products
Adverse reactions
Submitting a report on an adverse reaction
Medicinal products under additional monitoring
Product defects
Drug interactions
Pharmaceutical injuries
Correct use of medicines
Ensure the safety of your medication
Instructions for the safe use of medicines
Monitor the effects of your medication
How to store medicines?
How should medicines be disposed of?
List of medicines
Where can I find reliable information about medicines?
How can I assess the reliability of drug information?
Medicinal product packs
Package leaflet
How are medicines supplied to users in Finland?
What factors affect the availability of medicines?
Why might a pharmacy run out of my medicine?
Obligatory storing of medicines
Exemptions and special permits
Ordering medicines online
Why is the food supplement I ordered considered to be a medicine?
Medicines for children
Developing better medicines for children
Collaboration on medicines education
Medication of the elderly
What medicines can I bring abroad?
Pain relievers and self-care
Bringing medicines to Finland
Fimea’s services to citizens
Cooperation with patient associations
Influenza
Influenza vaccinations
Antiviral medication
Pandemic
Vaccines
Falsified medicines
Medicines and pregnancy
Pharmaceuticals and the environment
Current events
Substitution of biological medicines
Information for medicine users
Information for health care professionals
Fimea and wellbeing services counties
Coronavirus (COVID-19)
Frequently asked questions (COVID-19)
Adverse reactions reported on corona vaccines
Russian attack on Ukraine
News archive
Subscribe newsletter
Databases and registers
FimeaWeb
Meds75+
Frequently asked questions
National High-Risk Medicines Classification
Frequently asked questions
Consumption
Self-medication products
Basic register
Plasma-derived products with marketing authorisation
Substitutable medicinal products
Textfile for databases
Criteria used in compiling the list
ATC codes
Shortages
Development and HTA
Assessment of pharmacotherapies (HTA)
Assessment of hospital-only medicinal products
Topic selection
Nordic collaboration (FINOSE)
Assessment reports (in Finnish)
Medicines information
National Medicines Information Network
Materials of the Medicines Information Network
Medication Therapy Indicators
Use of Avoidable Medications in the Elderly
Significant Polypharmacy in the Elderly
Drug Expenses for the Elderly
Patient advisory board
Research
Research Network for Rational Pharmacotherapy (RATTI)
Marketing authorisations
Marketing authorisation application
Finland as a Reference Member State in the decentralised procedure (DCP)
Finland as a Reference Member State in the Mutual Recognition / Repeat Use Procedure (MRP/RUP)
Changing of Reference Member State duties to Finland
Finland as a rapporteur in the centralised marketing authorisation procedure (CP)
Granted and cancelled marketing authorisations
Pending marketing authorisation applications
Biological Medicinal Products
Orphan drugs
Paediatric medicines
European Pharmacopoeia
Active substance names and standard terms
Product Information
Summary of product characteristics
Package leaflet
Package labelling
Text templates
Braille and package leaflets for the visually impaired
Trade names of medicinal products
Strength
Translating influenza vaccines in Finland
Electronic marketing authorisation submissions
What's new
Instructions for electronic marketing authorisation submissions
Special characteristics of the electronic marketing authorisation process for veterinary medicines
Introduction to market
Shortage notifications
Frequently asked questions about reporting shortages
Innovation Office
Informal Regulatory Guidance
Scientific Advice
SNSA advice
Safety features
Other permits
Exemption
Interchangeable medicinal products
Herbal remedies and medicinal products
Herbal medicinal products
Traditional herbal medicinal products
Homeopathic and anthroposophic preparations
Parallel import
Cancelling a marketing authorisation or registration and sunset clause
Cancelling a marketing authorisation or registration
Expiration of marketing authorisations and registrations (sunset clause)
Sunset clause - concepts
Sunset clause exemption
List of expired marketing authorisations and registrations
Renewals and variation applications
Renewals
Variation applications
Changes to labelling
Transferring a marketing authorisation to a new holder
Article 5 classification requests for variation applications
OTC application
Frequently asked questions about marketing authorisations
Medical devices
What are medical devices?
Definition of medical devices
Special device groups
Software
Biomaterials
Nanomaterials
How to identify a medical device?
Topical information about devices
Fees for medical devices
Notifications and applications
Certificate of free sale
Derogation
Incident reports
Device registration
Device and operator notifications to Eudamed
Device and operator notifications to CERE
Legislation related to medical devices
Device manufacturers
Intended purpose and classification
General safety and performance requirements
Clinical evaluation and clinical investigations
Conformity assessment
CE marking
Labelling and instructions for use
Post-market surveillance
System and plan
Reports to be prepared
Manufacturer's incident reporting procedure
Incident report
IMDRF codes
Device distributors and importers
Importers
Distributors
Distributors' obligations
National language requirements
Reporting of incidents
Import to Finland of at-home tests
Repackaging and making of translations
Products without a medical purpose
Investigations with devices
Clinical investigations of devices
Performance studies of IVD-devices
Medical Device Advisory Clinic
Notified bodies
Designation of notified bodies
Supervision of notified bodies
Devices subject to specific additional procedures
Marketing of medical devices
Pharmaceutical safety and information
Pharmaceutical safety
Reporting adverse reactions
Frequently asked questions about reporting adverse reactions
Biological medicinal products
Advanced Therapy Medicinal Products
Biosimilars
Biosimilars in Finland
The position of Fimea towards interchangeability of biosimilars
Regulation on Medicinal Products for Paediatric Use
Paediatric Committee
Paediatric Investigation Plan
Coordination and communication
Rewards and incentives
Symbol in the labels of medicinal products
Pharmacies
Pharmacy licences
How to apply for a pharmacy licence
How to apply for a subsidiary pharmacy licence
Supervision Committee
Change of pharmacist situations
Pharmacy tax
Special permits
Applying for a special permit – Information for prescribers
Applying for a special permit – Information for the releasing party
Decision on the special permit, processing times and fees
Fixed-term special permits
Frequently Asked Questions
Manufacturing medicinal products
Schengen certificates
PIC/S GMP Guide
Dose-dispensing
Supervision
Pharmacovigilance
ICSR reporting to the EudraVigilance system
Pharmacovigilance inspections
Product defects
Summaries of risk management plans
Product-specific risk minimisation material
Pharmacovigilance requirements for parallel distribution and parallel import products
Clinical Drug Trials
Clinical Trials Regulation & CTIS
Trials under the EU Regulation
Trial application and modifications
Transition of clinical trials
Safety reporting in clinical trials
GCP inspections
Frequently asked questions about Clinical drug trials
Advertising of medicinal products
Classification
Principles of classification
Classification application
List of medicines
After classification
Pharmaceutical industry
Licenses
Local pharmaceutical wholesale license holders
Registered brokers of medicinal products
Good Laboratory Practice (GLP)
Obligatory storing of medicines
List of products to be stocked as obligatory storage
Notifying the obligatory storages
Applying for a permit to maintain lower obligatory storage levels
Applying for an exemption
Special arrangements for the fulfilment of storage obligation
Establishments
Supervising tissue establishments
Supervision of organ activity
Certificates of a Pharmaceutical Product (CPP)
Applying for an export certificate
Narcotics control
Additional information to be submitted with narcotics licence applications
Frequently asked questions
Batch-specific control
GMP certificates
Gene technology
Supervision of contained use
Inspection process
Supervision of deliberate release
Gene technology register
Laboratory of Fimea
National and international collaboration
Legislation, regulations and guidelines
European Pharmacopoeia
National pharmacopoeia documents
To users of the Pharmacopoeia
CEP Procedure
International Non-proprietary Names for Pharmaceutical Substances (INN)
Additional Pharmacopoeia materials
Administrative regulations and guidelines
Blood services
Licence of a Blood Establishment
Hospital Blood Banks
Hemovigilance
Blood as a starting material for medicines
Legislation on blood service activities
Biobanks
Biobank consent
National biobank register
Guidance and supervision of biobanks at Fimea
Tissue establishments
Licence for tissue establishment
Tissue establishment register
Biovigilance
Regulations on human tissues and cells
Instructions for tissue establishments
Veterinary
Marketing authorisation procedures
National procedure
Mutual recognition procedure
Decentralised procedure
Centralised procedure
Validity of marketing authorisations
Applications for variations to marketing authorisations for veterinary medicines
Special permits for compassionate use
Applying for special permit
FAQ
A Questions and answers on how to fill in the form
B Questions and answers regarding the technical aspects of permit application
C Questions and answers regarding the decision and the processing of the application
D Other questions and answers
List of special permits for veterinary medicinal products
Adverse effects
Consumption of veterinary antimicrobials
The European Surveillance of Veterinary Antimicrobial Consumption ESVAC
Clinical trials on veterinary medicinal products
Immunological products
Withdrawal period and MRL
What is a withdrawal period?
MRL
Horses as food-producing animals
Private import
About us
Contact us
Change of address
Copyright
Contact
Personnel
Secure Mail
Open positions
Forms
Organisation
Strategy
Sustainability
International representation
Fimea committees
Publications
Fees
Frequently asked questions about invoicing
Estimated processing times
Data requests
Data access authorisations
Open data
Reports of breaches in accordance with the act on whistleblower protection
Frequently asked questions
Frontpage
en
Marketing authorisations
Frequently asked questions - marketing authorisations
Frequently asked questions - marketing authorisations
FAQ Frequently asked questions about electronic marketing authorisation applications
Summary of Product Characteristics is to be available also in Swedish
Local representative
Print
Hidden
close-info