Pharmacovigilance in Latvia
How is it with the drug safety system in this Baltic 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 Latvian pharmacovigilance services:
LCPPV / EU QPPV in Latvia
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Latvia?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Latvia is the State Agency of Medicines (ZVA).
ZVA is responsible for the supervision and regulation of medicinal products, including monitoring adverse effects and ensuring the safety of medicines used in the country. The State Agency of Medicines, the agency is located in Riga.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has an English version and it seems to provide almost all of the important information regarding pharmacovigilance, though some deeper pages (as some statistics or some information for MAH for example) are accessible only in Latvian version.
If you’re struggling to find what you need, we recommend checking the Latvian version of the website and using translation tools like Google Translate; this could help you uncover the information you’re after.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE FOR MAH
Here you will find basic information on pharmacology, SAM activities, National level contact person and more. There is also pharmacovigilance page as a subsection to Healthcare professionals where, in addition to the above, you will also find, for example, statistics. Also some information, such as regarding PSURs, RMP and others, can be found only when using the Lithuanian version.
MARKETING AUTHORISATION HOLDERS
The main signpost for all important information related to MAH, you’ll find here information regarding renewal and withdrawa of MA, Pre-authorisation, Post-authorisation and more.
MEDICINAL REGISTER
The Online Medicinal Product Register search form is a handy tool for finding information on medicines listed in Latvia and those authorized in the European Union, allowing users to easily search by product name, active substance, marketing authorization holder, or ATC code, with options to refine their results further.
DRUG CONSUMPTION STATISTICS
Here you’ll find individual tables regarding drug consumption for each year from 2010, only in Latvian. There is also table for 2024 and it is continuously updated as the months go by. There is also a statistic for the drug market dynamics.
LEGISLATION
This section contains all the important laws and regulations regarding health, laws and regulations are sorted into individual categories, links for the legislation provide English versions of the texts.
BULLETIN
“Cito!” is an informative bulletin designed for physicians, pharmacists, and other healthcare professionals, providing them with the latest scientifically-backed updates and recommendations on medication safety, along with important changes in the Drug Register of the Republic of Latvia.
Other important institutions & industry groups
MINISTRY OF HEALTH & HEALTH INSPECTORATE
The ministry is responsible for defining national health policies, regulations, and overseeing public health initiatives, it also plays a central role in health promotion and disease prevention strategies.
On the other hand, Health Inspectorate is responsible for monitoring and ensuring compliance with healthcare regulations, conducting inspections of medical institutions, and safeguarding public health.
When using the Inspectorate website, we reccomend to use the Latvian verison, since the English one offer very limited content. Though content regarding pharmacovigilance seems to be missing, you can see some infographics on Public Health, Pharmacy and other areas or see the Health Inspectorate Monitoring Results Reports, though materials in both sections are only in Lithuanian.
Ministry’s website: https://www.vm.gov.lv/lv
Inspectorate’s website: https://www.vi.gov.lv/lv
LITHUANIAN GCP & RA ASSOCIATION
As it seems, this association was formerly known as the Association of the Latvian Chemical and Pharmaceutical Industry (LAKIFA). It represents companies involved in manufacturing and distributing pharmaceuticals, chemicals, and related products. It promotes innovation, competitiveness, and cooperation among its members.
If you want to know more about the chemical industry in Latvia, you should visit this page, where you can find variety of videos regarding stories and oppurtunities. When scroll down a bit, there is also a infographic section, providing you overall information about the industry in numbers.
Association’s website: https://lifescience.lv/
PHARMACEUTICAL CARE ASSOCIATION OF LATVIA
This organization unites pharmacy companies to improve pharmaceutical care in Latvia. Its objectives include enhancing the regulation of the pharmaceutical sector and increasing the availability of services provided by pharmacies.
To learn more information about the pharmaceutical industry visit this page, it’s basically a Q&A. You won’t find much infographics on this website, only two, but still – they are worth seeing. One of them is regarding how has the number of pharmacies developed and the other one industry turnover.
Association’s website: https://lfaa.lv/en/
Some of the most important laws
Basic legislation
This law regulates the activities of individuals and entities in the pharmaceutical sector.
Regulation No 47 “Pharmacovigilance Procedures”
This regulation outlines the procedures for pharmacovigilance specifically for medicinal products intended for human use.
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
Since Latvia is a member of the EU, every Marketing Authorization Holder with a product on the Latvian 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 Latvia, 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
ZVA (Zāļu valsts aģentūra)
→ State Agency of Medicines / Main authority on pharmacovigilance.
Is LCPPV needed or is EU QPPV enough?
The Local Contact Person for Pharmacovigilance (LCPPV) is necessary unless the EU Qualified Person for Pharmacovigilance (QPPV) is both residing and working in Latvia, based on Regulation No 47 “Pharmacovigilance Procedures”.
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 Latvia?
Healthcare professionals and marketing authorization holders can submit reports electronically through the EudraVigilance system, more information here.
Patients and Healthcare professionals can use online reporting via forms linked here.
Local medical journals to screen
Here are few examples of Latvian local literature sources that medical authorization holders should monitor:
PROCEEDINGS OF THE LATVIAN ACADEMY OF SCIENCES
This peer-reviewed journal publishes original research and reviews across various scientific disciplines, including biological and medical sciences.
It serves as a platform for significant research findings from Latvia and beyond, making it essential for anyone, who is interested in the latest scientific advancements.
ISSN: 2255-890X
MATERIA MEDICA (only print)
Published by the Latvian Society of Pharmacists, this journal provides critical information on pharmacology and therapeutic practices and drug development.
It’s particularly useful for pharmacists looking to enhance their knowledge and practice standards.
ISSN: 1024-1590
LATVIJAS ĀRSTS
This national medical journal focuses on a wide range of health topics relevant to Latvian healthcare professionals.
It features articles that address both practical and theoretical aspects of medicine, making it an essential read for those involved in patient care.
ISSN: 1019-5068
DOCTUS
Aimed at physicians and pharmacists, DOCTUS offers insights into current medical practices, innovations, and continuing education.
It is a valuable resource for healthcare professionals seeking to stay updated on clinical guidelines and emerging therapies.
ISSN: 1407-821X
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
Latvia: Country Health Profile 2023
The 2023 edition of “State of Health in the EU: Latvia” 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 ZVA
ZVA’s annual reports can be found in About the agency, reports are sorted by year and each report can be downloaded as PDF document.
Book “Introduction in Pharmacovigilance”
The authors of this insightful book emphasize the importance of considering medication use as a potential factor in health disorders during diagnosis, highlighting how physicians’ observations can lead to safer medication practices and further research.
Baltic Statistics on Medicines 2016-2018
It provides a deep dive into medication consumption trends across Lithuania, Latvia, and Estonia over three years, marking its third edition since 2013. This comprehensive analysis not only highlights similarities in medicine use among the Baltic States but also features expert insights on how changes in reimbursement and treatment guidelines have influenced specific drug categories.
When you come across a pharmaceutical term in Lithuanian and want to be sure of the correct translation, visit this site.
Studies related to pharmacovigilance in Latvia
An expert review of clozapine in Eastern European countries: Use, regulations and pharmacovigilance
This study compares the prevalence, regulations, and pharmacovigilance practices surrounding clozapine, revealing surprising insights, you’ll discover how clozapine prescription rates vary wildly and why improving monitoring practices is crucial for enhancing patient safety.
Do you need some help with putting the Latvian 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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