LaMarket surveillance provides that if any person within the company takes charge of an adverse report relative to its own product, the same person must activate all the appropriate procedures to retrieve all relevant information to verify the existence of a causal link between the use of the product and the adverse reaction. Once performed this preliminary investigation it is necessary to evaluate all elements obtained and make a judgment about the event.
If there was a serious undesirable effect it is necessary to inform the local Authorities and initiate all procedures of health caution including the withdrawal of the batch from the market.
In order to help its customers in performing in the best way this activity, Gruppo Farmaimpresa provides a Market surveillance service (Vigilance for Devices, Cosmetovigilance, phytovigilance) or the following services:
- Using the free number 800 912 941 to be inserted on websites, packaging, brochure for the reporting of adverse events
- Management of the received communication (complaint, reporting, non-compliance)
- Collection of informations necessary to assess the adverse reactions
- Assessment of the causal link with the help of suitable tests and expert opinions (doctors, chemists, biotechnologists)
- Management of the communication of serious undesirable effect to the Authorities
- Updating the analysis of risks with any corrective actions
- Regulatory Update