Pharmacovigilance is not an isolated procedure: it is a continuous system that protects patients and safeguards the validity of your health registrations. For holders, clear processes reduce regulatory and reputational risk.
Essential components
- Documented procedures for receiving and reporting adverse events.
- A pharmacovigilance officer with defined responsibilities.
- Reporting timelines aligned with current regulations.
- Safe storage and traceability of information.
Why it matters for the holder
The authority may link pharmacovigilance compliance to the validity of the registration. A strong system demonstrates control over the product life cycle and facilitates audits and inspections.
As an independent regulatory holder, at Inteligencia Sanitaria we integrate these obligations without interfering with the distribution or commercialization of your product.