Pharmacovigilance in Finland
How is it with drug safety system in European country? Follow our guide and you will be in the picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Finnish pharmacovigilance services:
Finland’s LCPPV/EU QPPV
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Finland?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Finland is The Finnish Medicines Agency, commonly known as Fimea, headquartered in Helsinki. Fimea is responsible for the regulation and supervision of medicinal products, including pharmacovigilance activities.
Its activities are governed by the Finnish Ministry of Social Affairs and Health.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version and practically every page is translated, some deeper pages or section might be only in Finnish.
Therefore, if you cannot find what you’re looking for, we suggest you to use the website originally in Finnish (Suomi) and use translator, this way you have potentially much bigger chance to find it.
Interesting website sections related to pharmacovigilance
MARKETING AUTHORISATION
A signpost where you can find everything important regarding MA such as application, electronic submission, introduction to market and more.
FORMS & OTHER PERMITS
You can find Fimea’s forms organized by topic right here, making it easy to navigate. Forms are covering everything from marketing authorizations to various permits and certificates related to medicinal products.
PUBLICATIONS
You can find all Fimea publications (basically only in Finnish) conveniently in Julkari, an open publication archive managed by the Ministry of Social Affairs and Health, making it easy to access essential insights.
In this section you can also find Finnish Statistics on Medicines, the latest number is from 2022.
FREQUENTLY ASKED QUESTIONS
On this page, you’ll find answers to frequently asked questions about Fimea’s operations, covering topics like biological drugs, clinical drug trials, and marketing authorizations.
NEWSLETTER
Subscribe to the Fimea’s newsletter, you can choose which areas of healthcare interest you and personalise the newsletter, accesible only in Finnish.
FIMEAWEB
This is Fimea’s medicine database, search here for any medicine placed on Finnish market, search simply by name or use advanced search.
Other important institutions & industry groups
MINISTRY OF SOCIAL AFFAIRS AND HEALTH (Sosiaali- ja terveysministeriö)
This ministry is responsible for drafting legislation, guiding the development of healthcare and social welfare services, and coordinating health policies at a national level.
Find out more about both legislation projects, such as The European Accessibility Act or National service reform, and completed projects or dive into ministry’s publications section offering various articles in English.
Ministry’s website: https://stm.fi/en/frontpage
FINNISH INSTITUTE FOR HEALTH AND WELFARE (THL)
An expert agency that supports municipalities and hospital districts in health promotion and disease prevention, THL operates under the Ministry of Social Affairs and Health.
Check out their list of many ongoing projects and researches, such as Healthy Finland Survey or Action Plan on Alcohol, Tobacco, Drugs and Gambling. Also THL provides a wealth of statistics and registers that offer valuable insights into social welfare and healthcare, you can find out more here, and if you like statistics visit some of these databases.
THL website: https://thl.fi/en/main-page
PHARMA INDUSTRY FINLAND (PIF)
Represents the research-based pharmaceutical industry operating in Finland and is the industry’s opinion leader.
Discover what PIF is all about, explore their statistics on exports and imports, as well as investments in the pharmaceutical industry. You can also dive into their commitment to responsible marketing practices, which ensure that medicines are promoted ethically and transparently, reflecting Finland’s dedication to patient safety and informed healthcare decisions.
PIF website: https://www.pif.fi/
FINNISH PHARMACISTS’ ASSOCIATION
Represents 8,000 pharmacists, including 500 working in over 100 hospital pharmacies in Finland.
Explore what does Finnish pharmacists’s association do, discover what hospital pharmacists actually do in short video, or stay informed about advancements in the field and how they impact patient care through a monthly EU monitor by EAHP.
EAHP website: https://www.eahp.eu/members/finland
Some of the most important laws
Basic legislation
Finnish Medicines Act (Lääkelaki 395/1987)
An absolutely crucial act in Finnish health care outlining the regulatory framework.
Fimea’s Administrative Regulation 4/2013
This regulation provides detailed guidelines on pharmacovigilance practices in Finland.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Essential EU Legislation and EMA Guidlines
Since Finland is a member of the EU, every MAH with a product on the Finnish market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Is LCPPV needed or is EU QPPV enough?
No, LCCPV is not required, according to the Medicines Act 30 c §. Nevertheless, Fimea may request the nomination of a pharmacovigilance contact person at national level (LCPPV) for marketing authorisation holders (MAHs).
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Finland?
To submit a report, you can use the electronic reporting form available on Fimea’s website, which requires identification through Suomi.fi.
This form allows you to report suspected ADRs related to medicines used in humans or animals. It is also possible to report via email or phone.
Local medical journals to screen
Here are few examples of Finnish local literature that medical authorization holders should monitor:
FINNISH MEDICAL JOURNAL (Suomen Lääkärilehti)
A leading publication that keeps healthcare professionals in Finland informed with the latest medical research, case studies, and expert opinions.
With a focus on advancing medical knowledge and practice, it serves as an essential resource for doctors and healthcare workers looking to stay updated on developments in the field.
ISSN: 0039-5560
DUODECIM
Duodecim Medical Journal is a leading Finnish publication that serves as a vital resource for healthcare professionals, offering a mix of original research, case studies, and expert opinions.
Known for its commitment to evidence-based medicine and continuous medical education since 19th centruy.
ISSN: 2242-3281
SCANDINAVIAN JOURNAL OF PUBLIC HEALTH
A peer-reviewed journal that focuses on public health issues across the Nordic countries, making it a unique platform for sharing research and insights specific to this region.
With its emphasis on demographic changes and health service responses, this journal is essential reading.
ISSN: 1651-1905
THE SIC!
Engaging online magazine created by Fimea specifically for healthcare professionals and other stakeholders in the pharmaceutical field. Best of all, it’s free for everyone to read.
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Finland: Country Health Profile
The 2023 editions provide a comprehensive look at the health landscape in the country, exploring key topics such as overall health status, important health determinants and risk factors, and how the health system is organized and funded.
MEDICINES EDUCATION
The Medicines Education Portal
The UKK Institute and the Fimea have teamed up to enhance medicines education for children and young people. Their collaborative effort aims to provide reliable and unbiased information specifically for teachers and students in comprehensive schools.
HEALTHCARE system in finland
Find out more about Finnish healthcare system, how healthcare services are divided or how is it with private healthcare, about that and much more here.
Fimea's annual report
Fimea’s final accounts and annual report can be found in News archive, though it seems you have search for it as there is no page, on Fimea’s website, dedicated to annual reports.
Scientific publications regarding pharmacovigilance
Parental reporting of adverse drug events and other drug-related problems in children in Finland
Drug-related problems (DRPs) are surprisingly common in pediatric pharmacotherapy, yet few studies have explored them from the parents’ perspective. This survey investigates the lifetime prevalence and types of DRPs affecting children in Finland, shedding light on an often-overlooked issue.
Since 1994, the Finnish Prescription Register (FPR) has been a key resource for pharmacoepidemiology research, but it only includes data on reimbursed dispensations. This study aims to explore the contents of the Kanta database, which stores all electronically issued prescriptions since 2017, and compare its coverage with the FPR.
Pharma Industry Finland has released an exciting and comprehensive document that dives into the pharmacovigilance life cycle, highlighting the crucial roles of various stakeholders in monitoring drug safety.
Adverse drug reaction (ADR) reporting has been extensively studied in the Nordic countries, but Finland stands out because its reporting is completely voluntary, leading to significant under-reporting. This study aims to uncover how this voluntary system affects healthcare professionals’ willingness to report ADRs, explore the reasons behind incomplete reporting.
Do you need some help with putting the Finnish PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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