##  [INVIMA IVC-VIG-FM70: Updated Format for Submitting Risk Management Plan (PGR) Updates](/index%2ephp/mandate/invima-ivc-vig-fm70-updated-format-for-submitting-risk-management-plan-pgr-updates) 

May 28, 2026

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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