Pharmacovigilance in Ireland
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 Irish pharmacovigilance services:
Ireland’s LCPPV/EU QPPV
AVAILABLE
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Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Ireland?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Ireland is the Health Products Regulatory Authority (HPRA), located in Dublin. It is responsible for monitoring the safety of medicines and operates the national adverse reaction reporting system.
The authority collaborates with the European Medicines Agency (EMA) and other EU member states to ensure consistent monitoring and reporting of drug safety issues.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE AND POST AUTHORISATION SAFETY
This section offers essential pharmacovigilance and post-authorization safety information for marketing authorization holders, including EU legislation, adverse reaction reporting and more.
NATIONAL REPORTING OF ADRs
Here you can find qucik guidance for Marketing Authorisation Holders on reporting of Adverse Drug Reactions and also on Suspected Unexpected Serious Adverse Reaction.
NEWSLETTER
HPRA’s newsletter on medicinal products seems to be published four times a year (as PDF document) and it can be found in this linked section. But there are also other reports and you cannot filter it, so you have to search thoroughly.
PUBLICATIONS & FORMS
You can easily download and read all HPRA publications and forms right here. The materials are sorted into categories and in each category you will find a table with specific documents.
STRATEGIC PLAN 2021-2025
HPRA’s Strategic Plan outlines vision for the next five years, focusing on delivering better outcomes for both people and animals. Dicover more about this plan and concrete goals.
Other important institutions & industry groups
HEALTH SERVICE EXECUTIVE (HSE)
The HSE is responsible for delivering public health and social care services in Ireland. It operates under the Department of Health and manages hospitals, community health services, and various health initiatives.
You can visit medicine database from A to Z, just choose the letter and see all the information about concrete medicine. Or see their publication section, where you can find reports, strategies and more.
HSE website: https://www.hse.ie/
THE DEPARTMENT OF HELATH (An Roinn Sláinte)
Key institution in the Irish government responsible for health policy and the overall healthcare system, It is led by Minister for Health.
Learn more about Sláintecare reform, which is a revolutionizing healthcare delivery in Ireland, it’s about creating a fairer system for everyone. There are also many campaings that you can read about at departments’ website such as Healthy Ireland, which focuses on overweight and obesity.
website: https://www.gov.ie/en/organisation/department-of-health/
IRISH PHARMACEUTICAL HEALTHCARE ASSOCIATION (IPHA)
IPHA represents the inventors of medicines, including multinational pharmaceutical companies with operations in Ireland. It promotes innovation in medicines and ensures high standards of conduct in interactions with healthcare professionals.
IPHA brings you Medicines.ie, which is a another medicine databse, accoridng to them the most popular source when it comes to medicines information (such as information on the possible side effects, interactions with other medicines, etc.), clear table, sorted from A to Z.
IPHA website: https://www.ipha.ie/
MEDICINES FOR IRELAND (MFI)
MFI represents Irish-based manufacturers and suppliers of generic, over-the-counter (OTC), biosimilars, and hybrid medicines. It is one of the founding members of the Irish Medicines Verification Organisation (IMVO).
Visit their infographics section regarding value added medicines, generic medicines, annual saving s and more.
MFI website: https://www.medicinesforireland.ie/
Some of the most important laws
Basic legislation
This act consolidates various laws relating to the regulation of medicinal products.
Health Products Regulatory Authority Act 2007
This act established the HPRA and outlines its functions.
Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019
These regulations provide specific requirements for the marketing authorization of 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.
Essential EU Legislation and EMA Guidlines
Since Ireland is a member of the EU, every MAH with a product on the Irish market needs to follow the European pharmacovigilance legislation and guidelines by EMA (European Medicine Organization).
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 EU QPPV enough?
In Ireland, there is no legal requirement for the appointment of a Local Contact Person for Pharmacovigilance (LCPPV). The EU QPPV residing within the European Economic Area (EEA) is considered sufficient to meet pharmacovigilance obligations.
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 Ireland?
To report an adverse drug reaction in Ireland, you can use the HPRA Online Form and report ADRs directly through the HPRA’s online reporting system on their website.
You can also download the form and email it to HPRA.
Local medical journals to screen
Here are few examples of Irish local literature that medical authorization holders should monitor:
IRISH MEDICAL JOURNAL (IMJ)
Published monthly, the IMJ is one of the leading biomedical publications in Ireland.
It provides the medical community with scientific research, review articles, and updates on contemporary clinical practices.
ISSN: 0332-3102
ULSTER MEDICAL JOURNAL (UMJ)
An international general medical journal with a focus on material relevant to the health of the Northern Ireland population.
It is published three times a year by the Ulster Medical Society.
ISSN: 2046-4207
UPDATE JOURNAL
This journal covers clinical news, highlights from major medical conferences, and the latest treatment approaches across various specialties in Ireland.
Published by the Medical Independent.
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
Ireland: 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.
HPRA's annual report
HPRA’s anual report can be fouund in Corporate & Policy Documents, though you have to search for it there among other documents. Quicker way to find annual reports is to simply use the search on their website.
regulation overview
Life Sciences Regulation in Ireland: Overview
This Q&A offers a concise overview of essential topics in the life sciences sector, covering everything from clinical trials and manufacturing to marketing and pharmacovigilance.
Scientific publications regarding pharmacovigilance
This study investigates healthcare professionals’ knowledge and attitudes towards ADR reporting and awareness of additional monitoring in Ireland, highlighting the critical role that education and communication play in ensuring patient safety.
This thesis aims to compare and evaluate how healthcare professionals in Ireland and Nigeria report Adverse Drug Reactions (ADRs), using surveys and interviews to gather insights. The findings reveal significant differences in knowledge and awareness of ADR reporting between the two countries.
Active monitoring of 12760 clozapine recipients in the UK and Ireland
This study aims to identify risk factors for this serious side effect among patients on clozapine, emphasizing the importance of understanding these risks to improve patient safety and treatment outcomes
Do you need some help with putting the Irish PV System together? We’re here for you.
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