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Valitse kieli
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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
Antimicrobial resistance
Medicines that have marketing authorisation in Finland
Current events
Substitution of biological medicines
Information for medicine users
Information for health care professionals
National medicines data repository
Fimea and wellbeing services counties
Coronavirus (COVID-19)
Frequently asked questions (COVID-19)
Adverse reactions reported on corona vaccines
Russian attack on Ukraine
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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
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Assessment of pharmacotherapies (HTA)
Assessment of hospital-only medicinal products
Topic selection
Nordic collaboration through JNHB
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)
Medicines Barometer
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
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Safety features
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Exemption
Interchangeable medicinal products
Herbal remedies and medicinal products
Herbal medicinal products
Traditional herbal medicinal products
Homeopathic and anthroposophic preparations
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Sunset clause - concepts
Sunset clause exemption
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Renewals and variation applications
Renewals
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OTC application
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Medical devices
What are medical devices?
Definition of medical devices
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How to identify a medical device?
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IMDRF codes
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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
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Medical Device Advisory Clinic
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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
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
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Supervision Committee
Change of pharmacist situations
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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
Search for medicinal products requiring a special permit
Frequently Asked Questions
Manufacturing medicinal products
Schengen certificates
PIC/S GMP Guide
Dose-dispensing
Supervision
Pharmacovigilance
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Frequently asked questions about reporting adverse drug reactions (ADRs)
Pharmacovigilance inspections
Product defects
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Additional risk minimisation material for medicinal product
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Clinical Drug Trials
Clinical Trials Regulation & CTIS
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GCP – Good Clinical Practice
Frequently asked questions about Clinical drug trials
Advertising of medicinal products
Classification
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Licenses
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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 Nonproprietary 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
Supervision of cybersecurity and resilience
Cybersecurity
Resilience of critical entities
Frequently asked questions
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
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