Pharmacovigilance in Liechtenstein
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 Liechtenstein pharmacovigilance services:
LCPPV / QPPV in Liechtenstein
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
NOTICE
Since Liechtenstein is one of the smallest countries in Europe, with total population around 40 000 inhabitants, the amount of information regarding pharmacovigilance is noticeably less.
They have their own PV authority, but more important to them is that of Austria (BASG) and Switzerland (Swissmedic), with whom they work closely, thus information regarding Liechtenstein’s PV system can also be found at their websites.
Who is the main PV authority in Liechtenstein?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Liechtenstein is the Office of Public Health (Amt für Gesundheit), located in Vaduz. This office is responsible for overseeing the safety and efficacy of medicinal products within the country.
The tasks related to pharmacovigilance are primarily managed in collaboration with Austrian authorities
Useful insights about the authority website
NOTICE
The Office of Public Health (Amt für Gesundheit) do not have it’s own website as such, there is only one common website for governmental bodies, which is accessible in English.
CONTENT IN ENGLISH
The website has English version, and everything important seems to be translated. Though page dedicated to pharmacovigilance seems to be missing.
Still, if you cannot find what you’re looking for, we suggest you to use the website originally in German and use translator, this way you have potentially much bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
HEALTH SURVEY
In November 2014, the Office of Statistics has released a comprehensive health survey that offers valuable insights into the health behaviors and status of the population, along with information about the healthcare system. It seems that no more recent survey has been conducted since 2014.
HEALTH STATISTICS
Explore statistics regarding healthcare system in Liechtenstein in nicely organized, interactive infographics, accessible only in German.
Other important institutions & industry groups
LIECHTENSTEIN MEDICAL ASSOCIATION
This association represents medical professionals and plays a role in maintaining standards in healthcare delivery and medical practice within the country.
Association’s website: https://www.aerztekammer.li/
LIECHTENSTEIN INSTITUTE FOR HEALTH (LIG)
The LIG conducts research and provides data on health-related issues, contributing to evidence-based policy-making and public health strategies.
The Liechtenstein Institute for Health (LIG) does not appear to have a dedicated official website.
LIECHTENSTEIN INSTITUTE FOR HEALTH (LIG)
The LIG conducts research and provides data on health-related issues, contributing to evidence-based policy-making and public health strategies.
The Liechtenstein Institute for Health (LIG) does not appear to have a dedicated official website.
Some of the most important laws
Basic legislation
Law of December 18, 1997 (EEA Medicinal Products Act; EEA-AMG)
Establishes the regulatory framework for the authorization, safety, efficacy, and quality control of medicinal products and human tissues/cells within the EEA.
As of December 1, 2010, Liechtenstein has an agreement with Austria that allows for the automatic recognition of human and veterinary medicinal products authorized in Austria.
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), Liechtenstein 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
Cooperation with Swizterland and Austria
Liechtenstei has agreements with both countries ensuring coordinated safety monitoring of medicinal products, here are key points:
Cooperation
→ In pharmacovigilance and market surveillance with both BASG and Swissmedic.
Agreement with BASG
→ As of December 1, 2010, an agreement allows for the automatic recognition of human and veterinary medicinal products authorized in Austria.
Swissmedic’s network – Customs Treaty
→ ADRs related to products authorized in Switzerland must be reported to Swissmedic.
Permitting medicines
→ Liechtenstein automatically permits on its market the medicines approved by Swissmedic, the Swiss Agency for Therapeutic Products.
Is LCPPV needed or is EU QPPV enough?
No, a Local Contact Person for Pharmacovigilance (LCPPV) is not required in Liechtenstein.
The pharmacovigilance officer must be resident and active in the European Economic Area and is responsible for setting up and managing the pharmacovigilance system.
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 Liechtenstein?
Local medical journals to screen
Liechtenstein seems to rely on broader regional and international medical journals so, here are few examples of Swiss and Austrian local literature that medical authorization holders should monitor:
SWISS MEDICAL WEEKLY
The official scientific publication of several Swiss medical societies, including the Swiss Society of General Internal Medicine.
It publishes original and review articles across all fields of medicine.
ISSN: 1424-3997
SWISSMEDIC JOURNAL
The official periodical of the Swiss Agency for Therapeutic Products, published in German and French.
It covers topics related to therapeutic products, including legal regulations, risks, and announcements about medicinal products.
ISSN: 2234-9456
WIENER KLINISCHE WOCHENSCHRIFT
Founded in 1888, this is considered one of the most prestigious medical journals in Austria.
It is published by Springer and covers a wide range of medical topics.
ISSN: 1613-7671
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.
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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