Pharmacovigilance in Malta
Curious about the drug safety system on this charming Mediterranean island? Our guide provides a clear overview.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Maltese pharmacovigilance services:
Malta LCPPV / QP / EU QPPV
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main drug safety authority in Malta?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
When it comes to pharmacovigilance the main Maltese institution is the Malta Medicines Authority (MMA).
This is the organization responsible for ensuring the safety of medicinal products and monitoring adverse drug reactions (ADRs) within the country.
Interesting sections of MMA’s website related to pharmacovigilance
SAFETY ACTIVITIES SECTION
General information on Pharmacovigilance, mainly listing specific activities related to the roles and responsibilities of Marketing Authorization Holders in Malta.
Some specific local details are although covered in the Risk Management Plans section of the text (includes a link to archived risk minimisation measures) and Emerging Safety Information (ESI).
REGISTRATION OF MEDICINAL PRODUCTS
This webpage will help you to navigate through the types of Registration Procedures for Medicinal products in Malta.
Note: The links to the National, European and Centralised Procedures are highlighted just by bold text with no underline, make sure you do not miss them – they get you to subpages with a lot more details.
ONLINE FORMS FOR DOWNLOAD
List of accessible e-forms with instructions. It includes application documents related to transfer of Marketing Authorization, Article 61(3) notification (change to an aspect of Labelling and/or Package Leaflet), an application for the Certificate of a Pharmaceutical Product and similar forms.
APPROVED MEDICINES DATABASE
Interactive part of the website that allows search for medicinal products authorized for sale in Malta, along with their product details.
NOTIFICATIONS SUBSCRIPTION
You can receive news from MMA either by SMS or e-mail by filling a simple form on this page.
It is handy that it is possible to choose only specific areas you’d like to get the information from – Recruitment, Medicines Information, Product Recalls (Quality), News and Events, Safety Circulars.
PDF NEWSLETTER (ISSUES FOR DOWNLOAD)
A regular newsletter by the authority published every quarter as a PDF file.
It contains many sections such as General Information from MMA, MMA events etc., but probably the most interesting one we would recommend is the “General European Updates”.
Other important institutions & industry groups
MINISTRY OF HEALTH AND ACTIVE AGEING
Responsible for health policy, healthcare provision, and public health initiatives in Malta. It oversees public healthcare services.
Here, if you’d be interested, is the complete list of public bodies along with links to the their websites. In the Resources section, you can see some of the ministry’s publications, mainly strategies for different areas and long-term plans.
Ministry’s website: https://health.gov.mt/
DIRECTORATE OF HEALTH INFORMATION AND RESEARCH (DHIR)
This organization is responsible for health data management, it conducts surveys, prepares related reports and identifies gaps in the Maltese health system.
Its website offers for example survey results such as European Health Interview Survey or National Health Interview Survey (2020). Then there are some fact sheets, such as those on obesity or birth defects, but only some are recent.
DHIR’s website: https://dhir.gov.mt/en/
HEALTH PROMOTION AND DISEASE PREVENTION DIRECTORATE (HPDP)
The HPDP institution is focused on promoting health and preventing diseases among the Maltese population through various initiatives and programs.
Under “Health Promotion & Chronic Diseases” in the section Health Promotion, you can find introductory articles on many themes (alcohol, sleep, smoking etc.). Also there is a section “Publications“, that includes links to materials on Baby’s health, Blood pressure or Cancer prevention for example (and it’s not only articles, but also some guides or Q&A).
HPDP’s website: https://hpdp.gov.mt/
MEDICAL ASSOCIATION OF MALTA (MAM)
Founded in 1954, MAM serves to regulate relations among medical professionals in Malta. It provides legal representation, advice, and support for its members, advocating for their interests within the healthcare sector.
Honestly, not much to see on their site as you can read about their aims and their purpose on the homepage, visit their Latest news section, where you can learn something more about what’s going on in the health area, industry or in the Association, but that is pretty much all information available there.
MAM’s website: https://mam.org.mt/
Some of the most important laws
Related local legislation
Medicines Act (Legislation 458)
The main regulation of medicinal products in Malta.
Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34)
These regulations outline the requirements and procedures for obtaining marketing authorization for medicinal products intended for sale in Malta.
Maltese Pharmacovigilance Regulations (Subsidiary Legislation 458.35)
Local regulations that establish the framework for the implementation of a pharmacovigilance system in Malta based on EU directives.
European 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 Guidelines
Since Malta is a member of the EU, every Marketing Authorization Holder with a product on the Maltese 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 documents:
– 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 Malta, 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
MMA (Malta Medicines Authority)
→ main authority on pharmacovigilance
Is LCPPV needed or is EU QPPV enough?
Information answering this question can be find in following very helpful local guidance document (page 6):
For similar 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 Malta?
Patients, consumers and healthcare professionals can report side effects through this page, where specific instructions are stated. The form can be sent to the Medicines Authority either online or offline.
Local medical journals to screen
Here are a few examples of Maltese local literature sources that Medical Authorization Holders should monitor:
MALTA MEDICAL SCHOOL GAZETTE
This journal publishes research and reviews on various medical topics, including pharmacovigilance.
It is a useful resource for healthcare professionals seeking to stay informed about the latest findings and practices in the Maltese medical community.
ISSN: 2521-0963
MALTA JOURNAL OF HEALTH SCIENCES
This journal focuses on health sciences research, including studies related to pharmacovigilance and drug safety.
It aims to share knowledge that can improve public health policies and practices in Malta.
ISSN: 2312-5705
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
Materials by Medicines MAlta Authority
Local Guidance on Pharmacovigilance Obligations
Already mentioned once on this page in the LCPPV obligation section above, but to make sure you do not miss it, we include the link once again as this is certainly a local document to get familiar with.
MMA: Presentations & Publications
Almost hidden in the website structure, this is a helpful section containing many useful documents, including a comprehensive slide deck “Marketing Authorisation Assessment” which we can fully recommend to study. There is also an overview of the MMA’s history, roles and activities in a brochure format.
Also, when you scroll at the bottom of the page, notice a link to the Pharmacovigilance resources subsection with a set of materials on related topics such as reporting ADRs or Post-Licensing in Malta.
The Malta Medicines Authority publishes regular reports with comprehensive overview of the agency’s activities and achievements over the years.
Scientific publications related to Maltese pharmacovigilance
Review of ICSRs received by MMA between 2004 and 2019
Using ICSR data from Maltese drug safety authority MMA, the study tries to analyse ADR reporting in the country and identify tools to motivate healthcare professionals to take part in pharmacovigilance activities.
Pharmacovigilance within a centralised procurement system
A doctoral dissertation that is based on a research about pharmacovigilance activities related to the Central Procurement Unit (CPSU) in Malta and its processes that ensure access to unregistered medications.
Insights from local Maltese learning program “Pharmacovigilance Award”
In January 2024, Malta Medicines Authority established an academy “offering a comprehensive understanding of pharmacovigilance legislation, guidance, and practical considerations for ensuring medicinal product safety.” and the paper shares learnings from this local project.
Improving the data quality of spontaneous ADR reports: a practical example from Malta
A study with a goal to improve “the data quality and reporting rates of ADR reports in Malta through a series of national activities”.
Health and Population Data about Malta
SoHEU Malta – Country Health Profile 2023
A publication “State of Health in the EU” by European Observatory on Health Systems and Policies and OECD is available in the link above in a local Maltese-specific version.
This page contains basic staticsits about Malta in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Maltese Pharmacovigilance System together? We’re here for you.
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