##  [INVIMA ASS-RSA-FM195: Submission of Modifications to Product Labelling Administrative Information (Safety and Efficacy)](/index%2ephp/mandate/invima-ass-rsa-fm195-submission-of-modifications-to-product-labelling-administrative-information-safety-and-efficacy) 

May 26, 2026

INVIMA published ASS-RSA-FM195 on 26-May-2026 (original document date: 11-Feb-2026), establishing structured requirements, procedures, and data fields for submitting modifications to the administrative information of product labelling associated with safety and efficacy, in alignment with Decree 334 of 2022.

**Policy Focus:**

- Updated submission format for modifications to product labelling administrative information under Decree 334 of 2022.

**Scope:**

- Applicable to biologics, medicinal products, vaccines, and medical gases subject to sanitary registration modifications before INVIMA.

**Key Requirements / Provisions:**

- General Framework: Guidelines for labelling administrative information modifications; prerequisite approvals for safety and efficacy texts.
- Applicant Information: Contact details, electronic notification authorization, banking transaction data, and personal data consent.
- Product Identification: Health registration number, product name, active ingredient, pharmaceutical form, validity, manufacturer, importer, and holder details.
- Change Classification: Product categories (biological, biotechnology, vaccine, chemical synthesis, medical gas); selectable labelling change types including QR code updates, packaging modifications, and insert adjustments.
- Supporting Documentation: Labels, inserts, instructions for use; detailed modification categories covering indications, dosage, age group, contraindications, warnings, and interactions.

**Regulatory Goals:**

- Standardize and streamline submission of labelling administrative modifications.
- Ensure compliance with Decree 334 of 2022.
- Maintain traceability of approved labelling changes.



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