Pharmacovigilance in Sweden
How is it with the drug safety system in this Scandinavian state? 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 Swedish pharmacovigilance services:
LCPPV / EU QPPV in Sweden
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Sweden?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Sweden is the Swedish Medical Products Agency (Läkemedelsverket). This agency is responsible for the regulation and surveillance of pharmaceuticals, including the monitoring of drug safety and adverse effects. It operates from its headquarters in Uppsala.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, important pages are translated, but some deeper pages or sections are only in Swedish such as Q&A, bulletin etc.
If you’re having trouble finding the information you need, we recommend checking out the Swedish version of the website and using online translation tools like Google Translate; this could help you uncover the details you’re looking for.
Interesting website sections related to pharmacovigilance
MARKETING AUTHORISATION
This page is basically a signpost, that can direct you into the exact area that you’re looking for. It contains information regarding Product information, Centralised & Decentralised procedure, Applications for marketing authorisations and much more.
FORMS, TEMPLATES & E-SERVICES
Here you can access the all forms, they can be sorted by advanced search on the left, all forms can be dowloaded as PDF.
The Swedish section contains more than twice as much forms as does the English section, so if cannot find some forms, try the Swedish one.
LEGISLATION SECTION
On this page, you’ll find key laws and regulations, these resources are essential for understanding the framework. In the menu on the left side you can also find the section with upcoming legislation.
QUESTIONS & ANSWERS
Vast Q&A section with a massive amount of content, here you can find your answer basically to anything, not just the field of pharmacovigilance.
SEARCH A DRUG
You can find all medicinal products approved for market placement in this user-friendly database, which allows for easy searching by name or through advanced search options.
NEWSLETTERS
This page contains a variety of newsletter, which gives you the opportunity to choose exactly the right one for you, only in Swedish.
Other important institutions & industry groups
MINISTRY OF HEALTH & SOCIAL AFFAIRS
Responsible for policies related to social welfare, medical care, public health, and social services. It oversees various agencies and initiatives aimed at promoting health and ensuring care for the sick and vulnerable populations.
On ministry’s website there is not much to recommend since there is basically just the news (when you scroll down a bit), at least when you’re using English version. When using Swedish version there is also legislation section, where all legal documents regarding public health.
Ministry’s website: https://www.government.se/government-of-sweden/ministry-of-health-and-social-affairs/
PUBLIC HEALTH AGENCY OF SWEDEN (Folkhälsomyndigheten)
This agency focuses on public health issues, promoting health, preventing illness, and protecting against health threats. It serves as a national knowledge authority in public health matters.
This is particularly interested for those, who like statistics, because there is vast section of these. Here is a overall singpost that you can use to navigate yourself through the areas of statistics, if you’re interested in public health go here, if in pharmaceuticals visit Statistics Sweden, where you can find some numbers on everything. Also if you’d like more some information on public health or you want to read some publications, this agency got you covered.
Agency’s website: https://www.folkhalsomyndigheten.se/the-public-health-agency-of-sweden/
SWEDISH ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY (Läkemedelsindustriföreningen – LIF)
This trade association represents the research-based pharmaceutical industry in Sweden, with around 90 member companies. LIF advocates for the interests of its members and is affiliated with European and international trade associations, such as EFPIA and IFPMA.
Statistics can also be found on LIF’s website,the association publishes annual compilations that provide valuable insights into pharmaceutical costs, usage, and sales both in Sweden and internationally. Or you subscribe to their newsletter to receive the latest news about all areas of the pharmaceutical industry.
LIF’s website: https://www.lif.se/
SwedenBIO
A national non-profit organization that represents the life science industry, including pharmaceuticals, biotechnology, diagnostics, and medical technology. SwedenBIO has over 300 members, ranging from startups to large enterprises, and aims to promote a conducive environment for growth and innovation in the life sciences sector.
We definitely have to recommend their Reports and fact sheets section, where many interesting publications can be found, such as The Swedish Drug Discovery and Development Pipeline Report 2023, which is aims to serve as a foundation for data-driven improvements in the pharmaceutical industry, or the Life Science Barometer, which is aimed to capture the current state of the life science industry, providing you with a snapshot of its optimism, concerns, and emerging trends.
SwedenBIO’s website: https://swedenbio.se/
Some of the most important laws
Basic legislation
Swedish Medicines Act (Läkemedelslag 2015:315)
This act provides the fundamental legal basis for the regulation of medicines in Sweden.
Swedish Medicines Decree (Läkemedelsförordning)
This doicument provides detailed regulations on the implementation and operation of pharmacovigilance systems.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Läkemedelsverket’s Guidellines
Complete list of Agency’s guidelines, these are not legally binding, they’re meant to help explain and clarify the content of a constitution.
Essential EU Legislation and EMA Guidlines
Since Sweden is a member of the EU, every Marketing Authorization Holder with a product on the Swedish market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Agency).
To navigate through the European regulations, its is useful to know following:
– EMA Pharmacovigilance System Manual
– Directive 2001/83/EC
– 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 Sweden, 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
LÄKEMEDELSVERKET
→ Swedish Medical Porducts Agency / Main authority on pharmacovigilance.
Is LCPPV needed or is EU QPPV enough?
In Sweden, there is no legal requirement to appoint a Local Contact Person for Pharmacovigilance (LCPPV); the EU Qualified Person for Pharmacovigilance (QPPV) residing within the European Economic Area (EEA) is sufficient.
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 Sweden?
All suspected ADRs should be reported to the Swedish Medical Products Agency (Läkemedelsverket). Reports can be submitted by healthcare professionals (mandatory), patients, or caregivers.
Use the Online Reporting System: here you can fill out a form detailing the suspected ADR.
Local medical journals to screen
Here are few examples of Swedish local literature sources that medical authorization holders should monitor:
ACTA DERMATO-VENEREOLOGICA
It publishes high-quality research in dermatology and venereology, featuring original articles and reviews that cover both clinical investigations and new scientific observations.
Its rapid publication process and rich visual content, make it an essential resource for professionals seeking the latest advancements in skin and sexually transmitted diseases.
ISSN: 1651-2057
ACTA ONCOLOGICA
This journal is dedicated to cancer research, providing a forum for the dissemination of significant findings in oncology.
Its unique emphasis on multidisciplinary approaches to cancer treatment and prevention makes it a crucial read for oncologists and healthcare providers looking to stay abreast of the latest developments in cancer care.
ISSN: 1651-226X
SCANDINAVIAN JOURNAL OF PUBLIC HEALTH
While primarily focused on public health issues, this journal frequently publishes articles related to drug safety and the impact of medications on population health.
Its multidisciplinary approach provides valuable insights into how pharmacovigilance intersects with broader health policies and practices.
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
Country Public Health / Health System Assessments
Sweden: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Sweden” provides 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.
Publications by Läkemedelsverket
Annual reports
As it seems the INFARMED’s annual reports do not have its own section on the website, so we recommend to search it manually, when searching use “Årsredovisning “. Here is Annual report 2023, only in Swedish.
The Swedish Medicines Agency’s strategic plan 2025–2029
The Swedish Medical Products Agency’s strategic plan outlines its goals for the next five years, informed by its annual mission and environmental analysis, to enhance the safety and effectiveness of medicines in Sweden.
Publications by other important institutions
Public health in Sweden – Annual report 2023
The report explores key aspects of health and the essentials that influence it, examining how these are distributed across different groups in society and how they change over time.
Studies related to pharmacovigilance in Sweden
Adverse drug reaction reporting by nurses in Sweden
This study is xploring the potential of nurses as a valuable resource for enhancing the reporting rate of adverse drug reactions (ADRs).
This study examines the impact of a 2007 legislative change in Sweden that required nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. While overall ADR reporting by nurses didn’t significantly increase after the new law, the study reveals a rise in reports of serious and unlabelled ADRs, suggesting that more proactive steps are needed to better engage nurses in this critical reporting process.
Do you need some help with putting the Swedish 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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