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Home / Activities / Safety / Reporting Adverse Drug Reactions

Reporting Adverse Drug Reactions

Pharmaceutical companies are legally obliged to submit reports of ADRs associated with their products on an expedited basis directly to Eudravigilance.   Guidance on the pharmacovigilance obligations of MAHs is available in Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations for Medicinal Products for Human Use.

In line with Directive 2001/83/EC (as amended), Regulation (EC) 726/2004 (as amended) and Pharmacovigilance Regulations 2012 (S.L 458.35) (as amended), MAHs are obliged to report suspected serious adverse reactions (expected and unexpected) occurring in Malta and suspected serious and unexpected adverse reactions occurring in the territory of a third country (non-EU/EEA).

ICSRs concerning suspected serious adverse reactions originating in Malta are no longer required to be transmitted electronically to the Medicines Authority with the message receiver identifier ADM. Moreover, MAHs are requested to submit ICSRs concerning suspected adverse reactions occurring in Malta and in the territory of a third country (non-EU/EEA) to EudraVigilance only with the message receiver identifier EVHUMAN. It is worth noting that ICSR submission to EVHUMAN encompasses reporting to the European Medicines Agency and to the Medicines Authority in line with the requirements of the Directive and Regulations mentioned in the preceding paragraph. The European Medicines Agency document (EMA/411742/2015 Rev. 9) further sets these requirements for Malta.

Directive 2001/20/EC (as amended) and the Clinical Trials Regulations 2004 (S.L. 458. 43) (as amended) instruct sponsors of clinical trials to report to the Medicines Authority suspected unexpected serious adverse reactions (SUSARs) arising from clinical trials conducted in Malta and from multi-centre clinical trials which include Maltese centers. Thus, SUSARs arising from clinical trials conducted in Malta and from multi-center clinical trials which include Maltese centers, should be submitted electronically by the sponsor to the EudraVigilance Clinical Trial Module (EVCTM) using message receiver identifier EVCTMPROD. It is worth noting that SUSAR submission to EVCTM encompasses reporting to the Agency and to the Medicines Authority as per the requirements of Directive 2001/20/EC (as amended).

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