##  [INVIMA ASS-RSA-IN56: Updated Guidelines for User Inserts, Prescribing Information (IPP), and Safety & Efficacy Modification Formats](/index%2ephp/mandate/invima-ass-rsa-in56-updated-guidelines-for-user-inserts-prescribing-information-ipp-and-safety-efficacy-modification-formats) 

May 26, 2026

INVIMA updated ASS-RSA-IN56 on 26-May-2026 (original document date: 11-Feb-2026), significantly expanding the scope and content requirements for user inserts, prescribing information (IPP), and safety and efficacy modification submissions.

**Policy Focus:**

- Expanded scope and strengthened content requirements for user inserts, prescribing information (IPP), and safety/efficacy modification submissions for biologics, medicinal products, and medical gases.

**Scope:**

- Applicable to marketing authorization (sanitary registration) applications and post-approval modifications for biological medicines, chemical synthesis drugs, and medicinal gases.

**Key Requirements / Provisions:**

- Expanded Scope: Now covers sanitary registration applications, not just post-approval modifications.
- SPC Alignment: Prescribing information aligned with SPC format with standardized structure.
- Detailed Indications: Requirements for target population and treatment intent including genotype/age specificity.
- Interactions & Dosage: Expanded requirements including washout periods, dose adjustments, special populations, and detailed administration guidance.
- Adverse Reactions: Stricter rules for wording; vague or non-evidence-based statements prohibited.
- Evidence Standards: Robust scientific evidence required for all claims; strict alignment with approved registration content.
- New Submission Formats: Addition of new/expanded submission framework and formats.

**Regulatory Goals:**

- Harmonize insert and prescribing information standards across product categories.
- Strengthen evidence requirements for labelling content.
- Align with international SPC standards.



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Source

<https://www.invima.gov.co/biblioteca/ass-rsa-in56pdf>

[https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologic…](https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/autorizacion-de-comercializacion-registros)

 

 

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