Pharmacovigilance
is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug-related
problem. In Malta,
the Medicines Authority is responsible for the co-ordination of the national Adverse
Drug Reactions (ADRs) reporting system, which was officially launched on 4 May 2004.
Following
implementation of the Medicines Act 2003, both Marketing Authorization
Holders (MAHs) and doctors, dentists and pharmacists have specific
obligations with regards to pharmacovigilance. The legal framework for these
obligations is described in the following legislation:
1.
Medicines Act 2003,
(Act No III of 2003) -
Amended by Act III of 2004
2.
Pharmacovigilance
Regulation 2006 (L.N.
61 of 2006)
3.
Codified
Directive 2001/83/EEC (Title IX)
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Further guidance on pharmacovigilance obligations is available in
Volume 9A of the Rules Governing Medicinal Products in the European Union:
Pharmacovigilance for medicinal products for human use.
Healthcare
professionals are legally obliged to report all suspected serious and
unexpected ADRs to the Medicines Authority. Healthcare
Professionals are hence requested to submit ADR reports using the freepost
ADR reporting card. Further guidance on the pharmacovigilance
obligations of healthcare professionals is available in
Adverse
Drug Reaction Reporting & Pharmacovigilance Guidance Notes for Healthcare
Professionals and related
Frequently Asked Questions (FAQs).
Pharmaceutical
companies are also legally obliged to submit reports of ADRs associated with
their products on an expedited basis to the Medicines Authority.
Further guidance on the pharmacovigilance obligations of MAHs is available
in
Guidance Notes for Pharmaceutical Companies on Pharmacovigilance
Obligations and Adverse Drug Reaction (ADR) Reporting Requirements for
Medicines for Human use and related
FAQs.
The staff of the
Post-Licensing Directorate are responsible for the scientific evaluation of
the ADR reports received and for the communication of the outcome of data
evaluation through the Drug Safety Bulletin. Moreover, the
Pharmacovigilance Section operates within a wider international framework,
including the EU and the WHO International Drug Monitoring Programme as full
members. Following the identification of a new ADR, the
Pharmacovigilance Section liaises with pharmaceutical companies for the
dissemination of this new information to Healthcare Professionals and the
update of the product information of the medicinal products for which a new
ADR has been identified.
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