Pharmacovigilance in Iceland
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 Icelandic pharmacovigilance services:
Iceland’s LCPPV/QPPV
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Iceland?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Iceland is the Icelandic Medicines Agency (IMA).
This agency is responsible for monitoring the safety of medicinal products and managing reports of adverse drug reactions. It operates from its headquarters located in Reykjavík.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, however there’s limited content, but the most important things seems to be translated, some deeper pages or sections are only in Icelandic.
Therefore, if you cannot find what you’re looking for, we suggest you to use the website originally in Icelandic and use translator, this way you have potentially much bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
General information about Pharmacovigilance, Reporting adverse reactions and EudraVigilance with important links.
EDUCATIONAL MATERIALS
The approval of a medication can come with extra safety measures ensuring that the product is used safely and effectively, Instructions for submitting educational materials and on electronic publication and removal of educational materials can be found in this linked section.
MARKETING AUTHORISATION
This section includes every important info you should know as MA, with more thorough information about Authorised Medicinal Products in the middle and about Electronic Applications, Package labelling & leaflets and more.
FAQ
Have you ever wondered wheter does the Icelandic Medicines Agency issue approval letters or whether does IMA require literature reports for Icelandic cases? Should a copy of the literature article be attached? Answers for that and more can be found in this section.
MEDICINE DATABASE
Here you’ll find information about all medicines that are marketed in Iceland, you can search simply only by name or use filters, such as Active ingredien, Pharmaceutical form and others. Databse is only in Icelandic.
FORMS TO DOWNLOAD
Section containing all the important forms, such as for licensing of medicines, reporting shortage, importation, manufacturing and distribution of medicinal products and more. Forms are sorted into categories, so it’s easy to find the one you’re looking for.
NEWS, PUBLICATIONS
The news section contains up to date news both in Icelandic and English, arranged by date of publication. The publication section, which is only in Icelandic, includes educational materials, podcast and more
Other important institutions & industry groups
MINISTRY OF HEALTH
It is responsible for administration and policy making in the healthcare sector, as prescribed by law, regulations and other directives. Nontheless it is also responsible for overseeing the healthcare system, ensuring that citizens have access to high-quality healthcare services.
You can visit legislation section on the ministry’s website, where you can filter in which area are you particularly interested and even find legislation regarding other ministeries. You can also read about the Health Services Act overall and see useful links.
Ministry’s website:
DIRECTORATE OF HEALTH
It is responsible for supervising healthcare services, promoting health and well-being, and preventing diseases in Iceland. It grants licenses to healthcare professionals and issues certificates confirming valid licenses to practice.
See the interactive statistics section on a variety of topics related to health, such as Healthcare Professionals, The Use of Pharmaceuticals, Drug-related deaths and more. What is worht mentioning is also section regarding published materials and forms. Statistics are only in Icelandic.
Directorate’s website: https://island.is/en/o/directorate-of-health
BIOTECH & MEDTECH ASSOCIATION OF ICELAND
The Biotech & Medtech Association of Iceland represents companies in the biotechnology and medical technology industries. Many pharmaceutical manufacturers are members of this association.
The association is a member association of the Federation of Icelandic Industries sadly does not posses a website as such.
Association’s LinkedIn: https://www.interpharma.ch/?lang=en
FRUMTÖK (The Icelandic Association of the Pharmaceutical Industry)
An internal body that represents the pharmaceutical industry in Iceland. It serves as an industry association for companies operating in the pharmaceutical sector.
Their website in English is trully simplified and basically without interesting information, at least regarding health and pharmacovigilance itself. When you switch to the Icelandic verison, you can find Brochures & documents, conatining a document named “Nordic summary – questions and answers” offering guidance for pharmaceutical companies on how to comply with local laws and industry codes when advertising to healthcare professionals in the Nordic countries.
Association’s website: https://frumtok.is/en/
Some of the most important laws
Basic legislation
This act regulates the marketing, distribution, and monitoring of pharmaceuticals in Iceland.
This is a key legal document that outlines the requirements for obtaining marketing authorizations for proprietary medicinal products.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
On educational materials, on marketing authorization withdrawals, on pricing and reimbursement and more.
Essential EU Legislation and EMA Guidlines
As part of the European Economic Area (EEA), Iceland 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
Is LCPPV needed or is QPPV enough?
In Iceland, the regulatory framework does not specifically require the appointment of a Local Contact Person for Pharmacovigilance (LCPPV) if the Qualified Person for Pharmacovigilance (QPPV) is already fulfilling the role and can communicate effectively in Icelandic, the QPPV must be located within the EEA.
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 Iceland?
The IMA provides online forms for reporting adverse reactions. There are separate forms for drug use in humans and for veterinary medications. After filling out the appropriate form, submit it directly through the IMA’s online system.
Local medical journals to screen
Here are few examples of Icelandic local literature that medical authorization holders should monitor:
ICELANDIC MEDICAL JOURNAL (Læknablaðið)
This is the most important local medical journal in Iceland is the.
It’s a open-access journal with peer-reviewed publication that covers a wide range of topics related to health and medicine in Iceland.
ISSN: 1670-4959
ICELANDIC JOURNAL OF NURSING
This a open-access journal focuses on advancements in nursing practices and promotes excellence across various nursing disciplines in Iceland.
It serves as significant platform for healthcare professionals to share research, clinical experiences, and insights relevant to the Icelandic healthcare system.
ISSN: 2298-7053
DANISH MEDICAL JOURNAL (Ugeskrift for Læger)
While not local journal, we have to mention of the most important medical journal in Denmark, that publishes research articles, reviews, and clinical studies relevant to the Danish healthcare system and medical practice.
Before 2012 it was called Danish Medical Bulletin and articles published before the renaming can be found here.
ISSN: 2245-1919
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
IMA ANNUAL REPORT
It provides a detailed overview of its activities, including statistics on drug approvals, clinical trials, and adverse drug reactions reported.
Iceland: 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.
Do you need some help with putting the Icelandic 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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