INVIMA updated IVC-VIG-FM70 on 28-May-2026 (original document date: 23-Feb-2023), redefining the format specifically for PGR updates and introducing new content and procedural requirements aligned with current regulatory frameworks.

Policy Focus:

  • Updated submission format exclusively for Risk Management Plan (PGR) updates, with expanded content and procedural requirements.

Scope:

  • Applicable to medicinal products and biologics/biosimilars requiring PGR update submissions to INVIMA.

Key Requirements / Provisions:

  • Redefined Scope: Format now specifically for PGR updates, not initial or general PGR submissions.
  • Summary Requirement: Only a concise summary of significant changes required instead of the complete PGR.
  • New Product Category: Addition of chemically synthesized (synthetic) products category.
  • Data Privacy: Incorporates personal data protection compliance requirements aligned with INVIMA data handling policies.
  • Updated Framework: Justification based on defined 'relevant modifications' and updated guidance documents.
  • Standardization: Fixed date formats, clearer instructions, and more structured/mandatory input fields.
  • Electronic Notification: Valid email required; users must monitor and update address as needed.

Regulatory Goals:

  • Standardize and streamline PGR update submissions.
  • Align with current pharmacovigilance and data protection frameworks.
  • Improve submission usability and regulatory traceability.

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