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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