Pharmacovigilance in Denmark
What’s the current landscape of drug safety in “the country of Hygge”? Use our guide and you’ll be well-informed.
Also, if you need a specific local pharmacovigilance advice, we’re here for you.
Current status of our Danish pharmacovigilance services:
LCPPV in Denmark
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Denmark?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Denmark is the Danish Medicines Agency (Lægemiddelstyrelsen), located in Copenhagen. Internationally known as DKMA, is responsible for ensuring the safety and efficacy of medicines, including the monitoring of adverse drug reactions.
In relation to DKMA, you may also come across the institution called The Danish Pharmacovigilance Council, which advises the Danish Medicines Agency on matters related to adverse reactions and pharmaceutical risks.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has English version, however it is quite simplified in terms of content volume. On the other hand, even though it is limited, the most important things are translated (while some deeper pages or sections are only in Danish).
In case you cannot find what you’re looking for, we suggest you to visit the website in the original Danish version and use a translator. This way you have potentially bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
THE DANISH PHARMACOVIGILANCE COUNCIL
Here you’ll find information about the council, including their main tasks, members etc.
Very interesting is a mention about public meeting minutes – these are available here (Danish only).
FORMS TO DOWNLOAD
Essential forms in one place: from marketing authorisation to side effects and incidents, all nicely categorized.
LEGISLATION
Though this section is named “Our targets and tasks”, it offers a better use than just definitions.
This is because fundamental laws regarding health system and pharmacovigilance in Denmark can be found here (but as always, we got you covered, so you also find these directly in the section of this guide below).
STRATEGY 2022-2026
Explore what is the Danish Medicines Agency’s mission, vision and strategy for the foreseeable future.
You can choose wheter you’d like to read short or more detailed description via link in the linked section.
ANNUAL PHARMACOVIGILANCE REPORT
In their publication section, an Annual Pharmacovigilance Report can be found – but only until 2016.
Since then, it seems nothing like that has been published (at least not in English), but some newer publications can be found on Danish version of the website.
NEWS ON PHARMACOVIGILANCE
This section provides news on specific medicines and adverse reactions, featuring insights from the PRAC and CHMP committees of the European Medicines Agency.
Once again, some materials of newer date can be found only on Danish version of the website.
NEWSLETTER
Here you can subscribe to the Danish Medicines Agency’s newsletter. It is possible to choose which areas of healthcare you are interested in and personalise it.
Other important institutions & industry groups
MINISTRY OF HEALTH (ISM)
The Danish Ministry of Health is responsible for overseeing the healthcare system in Denmark. It formulates health policies, regulates public health etc.
In 2022, the Danish government presented its healthcare plan that will cost over 900 000 EUR over the next 8 years, on their website you can read more about this reform. If you’d like to stay up to date, you can subscribe to the Ministry’s newsletter.
Ministry’s website: https://www.ism.dk/english
DANISH HEALTH AUTHORITY (Sundhedsstyrelsen / SST)
This authority is the supreme body for healthcare in Denmark and operates under the Ministry of Health. It advises the Minister and other authorities on healthcare policies and manages various health-related departments.
Though page dedicated to pharmacovigilance seems to be missing on their website, you can still view their Target and results plan (in Danish) or subscribe to their newsletter (just like with DMKA newsletter, you can personalise this one too).
Authority’s website: https://www.sst.dk/en/english
DANISH PATIENT SAFETY AUTHORITY (Styrelsen for Patientsikkerhed / STPS)
This authority is responsible for ensuring patient safety across the healthcare system. It works on iniciatives to prevent medical errors and improve the quality of care.
We recommend their publication section offering a variety of documents (you can sort these by subject word or year). For example annual reports can be found here, or questionnaire results.
Authority’s website: https://en.stps.dk/
DANISH GENERIC AND BIOSIMILARS MEDICINES INDUSTRY ASSOCIATION (IGL)
Founded in 2002, IGL focuses on the interests of companies producing generic and biosimilar medicines. It has 12 member companies and addresses issues related to patents and market conditions specific to generics and biosimilars.
It educates public on what generic medicines are, some interesting facts and their advantages. It also allows to explore how does the drug market work or why there are often large fluctuations in prices.
IGL website: https://www.igldk.dk/
DANISH ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY (Lægemiddelindustriforeningen / Lif)
Lif represents 41 member companies, both Danish and international, involved in the pharmaceutical sector. The association advocates for favorable conditions for research, innovation, and market access for its members.
We suggest you explore Danish pharmaceutical industry in figures (document is from 2021), read the analysis examining how clinical research is going or subscribe to their newsletter.
Lif website: https://www.lif.dk/en/
Some of the most important laws
Basic legislation
Danish Medicines Act (Lægemiddelloven)
This is the primary legislation defining the framework for the regulation of medicines in Denmark.
Outlines the overall framework for health services in Denmark.
Specifies the procedures and responsibilities for reporting adverse drug reactions.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities in member states of EU, including Denmark.
Essential EU Legislation and EMA Guidlines
Since Denmark is a member of the EU, every Marketing Authorization Holder with a product on the Danish 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 & terms to know
If you want to study local materials about pharmacovigilance in Denmark, 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.
CHMP (Committee for Medicinal Products for Human Use)
→ EMA’s assessment committee for medicines (more details nicely described here).
DKMA (Lægemiddelstyrelsen)
→ Danish Medicines Agency
Rådet for Lægemiddelovervågning
→ Danish Pharmacovigilance Council / It advises the DKMA on issues concerning adverse drug reactions and other risks associated with medications.
Is LCPPV needed or is EU QPPV enough?
Denmark does not require the appointment of a LCPPV unless specifically mandated by the Danish Medicines Agency (Lægemiddelstyrelsen).
In most cases, having an EU Qualified Person Responsible for Pharmacovigilance (EU QPPV) residing within the European Economic Area (EEA) is sufficient.
If you need a translation of Danish 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 Denmark?
Reports can be submitted through the Danish Medicines Agency (Lægemiddelstyrelsen). This can be done using their online reporting form available on their website.
There is also a general educational part of DKMA’s website related to side effects.
Local medical journals to screen
Here are few examples of Danish local literature sources that medical authorization holders should monitor:
DANISH MEDICAL JOURNAL (Ugeskrift for Læger)
Important local 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 prior to the renaming can be found here.
ISSN: 2245-1919
DANISH SCIENTIFIC JOURNAL (DSJ)
Denmark’s scientific journal that covers also health and medical fields.
As the journal is focused on international audience, articles are accepted in any language – the goal is to publish “materials on the most significant issues of our time”.
ISSN: 3375-2389
DANISH MEDICINES AGENCY PUBLICATIONS
While not a traditional journal, the Danish Medicines Agency regularly updates its publication section with reports and guidelines that include important data on adverse drug reactions and pharmacovigilance practices in Denmark.
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
Denmark: Country Health Profile 2023
SoHEU Denmark – Country Health Profile 2023
A publication “State of Health in the EU” by European Observatory on Health Systems and Policies and OECD is available here in Denmark-specific version.
HEALTHCARE OVERVIEW DOCUMENT BY DANISH AUTHORITIES
The Ministry of the Interior and Health of Denmark, along with Healthcare Denmark, has published a well-organized overview on Danish healthcare, where you’ll also find information about licensing of medicines, pharmacovigilance or new clinical trials regulation (all in section 9).
WEBSITE OF Healthcare denmark
Healthcare Denmark is a dynamic non-profit organization that brings together public and private sectors to showcase and promote Danish healthcare solutions on the global stage.
Keep yourself in the loop with the newest advancements in Danish healthcare innovation via their publications section or dive into the latest health data from the OECD’s database and discover how different countries compare in their healthcare systems.
Scientific publications rELATED TO DANISH pharmacovigilance
Pharmacovigilance on biologicals and biosimilars: a Danish perspective
Article focused on DKMA’s action plan for biological medicinal products.
A paper that compares the consistency of adverse drug reaction (ADR) information medications in Denmark and the USA.
Do you need some help with putting the Danish PV System together? We’re here for you.
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…consider also our global end-to-end PV solution!
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