Pharmacovigilance

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Pharmacovigilance

PHARMACOVIGILANCE ACTIVITIES AT IBC

Any pharmacovigilance-related situation in regard to the medicinal products sold in Argentina by IBC Lab is dealt with by health professionals in light of the national current regulatory framework and in accordance with Pharmacovigilance Good Practices.

The activities related to the receipt of notices on adverse events or any other special reported situations are validated, documented and compiled in compliance with current applicable regulations and the Pharmacovigilance agreements entered into between IBC and its licensors.

The Person Responsible for Pharmacovigilance (QPPV) guarantees that the following activities are performed, and ensures the required mechanisms are applied in order to meet the regulations set forth in connection with the medicines the PV of which such person is responsible for:

·Responding to any request for information received by the applicable authorities regarding safety of medicinal products in a timely and appropriate manner.

·Assessing the benefit-risk ratio during the after-sales period on a permanent basis and reporting any information that may involve a change in such ratio to the applicable authorities and licensors (if any).

·Outlining the necessary criteria to identify and value the seriousness of any alert signals in connection with IBC products.

·Reviewing scientific literature from time to time (including the ANMAT webpage – www.anmat.gov.ar) to check any suspected adverse reaction (SAR) of the active pharmaceutical ingredients (API) that IBC Lab owns.