Pharmacovigilance in Norway
How is it with the drug safety system in this Scandinavian country? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Norwegian pharmacovigilance services:
LCPPV / EU QPPV in Norway
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Norway?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The Norwegian Medicines Agency (DMP, formerly NoMA) is the main authority responsible for pharmacovigilance, located in Oslo. DMP has the overall responsibility for the national ADR reporting system and database.
Norway operates a national network consisting of four regional medicines information and pharmacovigilance centers (RELIS) that handle and assess ADR reports submitted by healthcare professionals.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, basically all important pages seems to be translated, but some deeper pages or sections are only in Norwegian such as forms etc.
If you’re having trouble finding what you need, we recommend checking out the website in its original Norwegian version and using a translator. This could significantly increase your chances of discovering what you’re looking for.
Interesting website sections related to pharmacovigilance
GOALS & TASKS
If you want to dive deeper into what exactly does and does not NoMA do, this is the page you were looking for, you’ll also find more information about individual departments here.
HEALTHCARE & PHARMACEUTICAL SYSTEM
This introduction offers a friendly overview of Norway’s pharmaceutical system, including how medications are priced and reimbursed, at the bottom there are also some interesting links such as Norwegian Pharma Profile.
PHARMACOVIGILANCE
All general information regarding pharmacovigilance in one place, regarding PRAC, reporting side effects, monitoring helath products and more.
PHARMACOVIGILANCE FOR MAH
Page specifically designed for marketing authorisation holders, regarding legislation, educational materials, FAQ and much more. The page might seem a bit empty at first sight, but there is menu on the left side, where all mentioned is sorted into individual categories.
APPROVAL & MAINTENANCE OF MA
All general information regarding this topic in one place, some shortcuts are placed in the middle, but all main individual categories are listed in the menu on the left side.
MEDICINE DATABASE
This is NoMA’s medicine database, search here for any medicine placed on Norwegian market, search simply by name or use advanced search.
FORMS TO DOWNLOAD
There are two sections from which you can download the forms. One contains those in English, and the other one contains those in Norwegian, where there are more than four times as many forms, so if you cannot find the right one, try both sections.
Other important institutions & industry groups
ROYAL NORWEGIAN MINISTRY OF HEALTH
This ministry is responsible for health policy, public health, healthcare services, and health legislation in Norway. It ensures equitable access to healthcare services for the population and oversees various health-related agencies and regional health authorities.
The linked government site contains all ministeries as subpages, thus that there is not much important information in the Ministry of Health section. However, we can mention their news section, where you can read more about the state budget and examine how much of it goes to health care or see some of their plans and strategies such as the one regarding women’s health.
Ministry’s website: https://www.regjeringen.no/en/dep/hod/id421/
NORWEGIAN INSTITUTE OF PUBLIC HEALTH
This institute conducts research and provides advice on public health issues, playing a vital role in monitoring health trends and outbreaks. Norway has four regional health authorities that manage hospitals and health services in their respective areas.
See their Public Health Report, which provides a detailed look at the health status of Norway, offering valuable insights and statistics. However, it is not a single report, it is divided into individual chapters. If you like statistics, you can also visit their section dedicated to drug consumption.
Institute’s website: https://www.fhi.no/en/
NORWEGIAN PHARMACY ASSOCIATION
Founded in 1881, this association represents all Norwegian pharmacies. It focuses on legislative and economic issues affecting pharmacies, professional development, and the advancement of technology and e-health services.
If you like both numbers and pharmacy industry, you will love this site, many numbers and statistics are waiting for you. We recommend Key Figures 2023, Top 10 Pharmaceuticals and Pharmacy & Drug staticstics (these two seems to be accessible only in Norwegian). And if you just want to watch something, the association’s got you covered, there is a short film about Norwegian pharmacies.
Association’s website: https://www.apotek.no/in-english/about-us
ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY IN NORWAY (LMI)
LMI is the primary trade organization representing both Norwegian and foreign pharmaceutical companies involved in the development, production, and marketing of medications in Norway.
This website does not provide English version, though there is a quick summary about pharmaceutical industry and a video “Why does it take so long for Norwegian patients to gain access to new medicines?“. If you want to know more about the industry here is a link for Norwegian version.
LMI’s website: https://www.lmi.no/
Some of the most important laws
Basic legislation
Medicines Act (Legemiddelloven)
This act provides the fundamental legal basis for the regulation of medicines in Norway.
Medicines Regulation (Legemiddelforskriften)
The Medicines Regulation provides detailed rules for the implementation of the Medicines Act.
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
As part of the European Economic Area (EEA), Norway has adopted the complete EU acquis on medicinal products through the EEA agreement such as the EU Regulation on Pharmacovigilance (Regulation (EU) No 1235/2010).
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
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Norway, following terms will be helpful for you to get familiar with:
EMA (European Medicine Organization)
→ Key part of the EU, dedicated to ensuring the safety and effectiveness of medicines.
EVPM (EudraVigilance post-authorization module)
→ Dedicated to the collection of ICSRs related to all medicinal products authorised in the EEA.
PRAC (Pharmacovigilance Risk Assessment Committee)
→ Committee responsible for assessing and monitoring the safety of human medicines
DMP (Direktoratet for medisinske produkter)
→ NoMA / Norwegian Medicines Agency
Is LCPPV needed or is EU QPPV enough?
In Norway, there is no legal requirement for a Local Contact Person for Pharmacovigilance (LCPPV) as the European Qualified Person for Pharmacovigilance (EU QPPV) is sufficient. The EU QPPV must reside within the European Economic Area (EEA) and is responsible for ensuring compliance with pharmacovigilance obligations.
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 Norway?
To submit a report, you can use the electronic reporting form available on NoMA’s website, for both healthcare professionals (dedicated platform) and public.
This form allows you to report suspected ADRs related to medicines used in humans. It is also possible to report via email or phone.
Local medical journals to screen
Here are few examples of Norwegian local literature that medical authorization holders should monitor:
THE JOURNAL OF THE NORWEGIAN MEDICAL ASSOCIATION
This is a well-respected peer-reviewed scientific journal that serves as a membership magazine for the Norwegian Medical Association.
It publishes articles on medical research, clinical practice, and health policy, aiming to enhance medical education and professional development within the medical community.
ISSN: 0807-7096
NORWEGIAN JOURNAL OF EPIDEMIOLOGY
This journal focuses on epidemiological research and public health issues in Norway.
It publishes original research articles, reviews, and methodological papers relevant to the field of epidemiology.
ISSN: 1891-5477
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
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
Norway: 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.
NoMA's annual report
NoMA’s annual report can be found in Organization and tasks, you can also search for it on NoMA’s website or Google, we reccomend to use Norwegian term for annual report “årsrapport”.
Government: Marketing Authorisation
Marketing authorisation of medicinal products
On this governmental website you’ll find basic information regarding procedures for marketing authorisation of medicinal products.
Scientific publications regarding pharmacovigilance
Adverse Drug Reactions in Norway
This systematic review has shed light on the current state of adverse drug reaction (ADR) reporting and monitoring within the Norwegian healthcare system, revealing both strengths and weaknesses.
Personalized medicine is revolutionizing healthcare by tailoring treatment strategies to fit each individual’s unique characteristics, such as their genetic makeup and lifestyle. The RELIS service stands out as a shining example of this personalized approach in action and in this analysis, not only you’ll find out why, but you also discover how personalized medicine is not just a buzzword but a vital shift towards a more tailored healthcare experience.
Characteristics and quality of adverse drug reaction reports by pharmacists in Norway†
In an eye-opening analysis of adverse drug reaction (ADR) reporting, researchers delved into the differences between reports submitted by pharmacists and physicians, uncovering some surprising trends. What makes this study particularly fascinating is the revelation that even though pharmacists’ reports were often less serious and had lower documentation quality, they still provided invaluable information that complemented the data from physicians.
Do you need some help with putting the Norwegian PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
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