## [INVIMA ASS-RSA-FM080: Updated Evaluation Format for New Association, Pharmaceutical Form and Concentration of Synthetic Medicines](/mandate/invima-ass-rsa-fm080-updated-evaluation-format-for-new-association-pharmaceutical-form-and-concentration-of-synthetic-medicines) May 28, 2026 INVIMA updated ASS-RSA-FM080 on 28-May-2026 (original document date: 22-Dec-2025), introducing functional changes to the pharmacological evaluation format for new associations, pharmaceutical forms, and concentrations of synthetic medicines. **Policy Focus:** - Updated submission format for pharmacological evaluation of new associations, pharmaceutical forms, and concentrations of synthetic medicines. **Scope:** - Applicable to medicinal products submitted for evaluation of new associations, new pharmaceutical forms, or new concentrations before INVIMA. **Key Requirements / Provisions:** - Electronic Notification: Mandatory consent with email and legal basis. - Expanded Details: Active ingredient with concentration; clearer manufacturer/importer/holder sections. - Redesigned Request Section: Includes classification, antecedentes, and tracking of prior or ongoing evaluations. - Pharmacological Section: Enhanced with special populations and requirement to align with prescribing information. - New Documentation: Risk management plan requirement added; internal evaluation/decision sections removed from form. - Application Types: New association, new pharmaceutical form, new concentration, and response to requirements. **Regulatory Goals:** - Standardize pharmacological evaluation submissions for synthetic medicine modifications. - Strengthen risk management integration from submission stage. - Improve traceability of prior regulatory antecedents. [Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/markdownify/node/13674) Source [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) Select Mandate HA [INVIMA](/mandate-by-ha/invima) Select Mandate Function [Regulatory Affairs](/mandate-by-function/regulatory-affairs)