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2 min read
With Decree 1474 of 2023, Colombia updated its pharmaceutical regulatory framework and adopted indefinite validity for marketing authorizations.
This change, aimed at improving administrative efficiency and ensuring product availability, eliminated the need for periodic renewals before INVIMA.
Although effective since 2023, its implementation still requires regulatory and quality adjustments to align with a model of continuous surveillance and traceability before the health authority.
Key Regulatory Implications
The shift to indefinite validity does not reduce the holder’s obligations—it transforms them. Oversight is now permanent and preventive, and evidence of compliance must always be available.
Critical aspects to consider:
- Commercialization notification: Holders must inform INVIMA about temporary interruptions or permanent withdrawals.
- Temporary withdrawals: Must be reported within 30 calendar days.
- Permanent withdrawals: Must be notified at least six months in advance.
- Post-approval variations: Any change in composition, process, manufacturer, or ownership must be managed through the appropriate route—standard notification, automatic variation, or prior authorization, depending on risk level.
- Audits and traceability: Companies must maintain internal systems documenting every update to demonstrate compliance during INVIMA inspections.
Toward a Model of Continuous Compliance
Decree 322 of 2023 strengthened communication duties in shortage cases and, together with Decree 1474, established a framework of ongoing regulatory responsibility.
Under this scheme, maintaining registration depends on the company’s ability to demonstrate sustained compliance.
For the pharmaceutical industry, this means shifting from a reactive approach—based on renewals—to a strategically anticipatory one, integrating:
- Systematic portfolio monitoring
- Cross-functional coordination between regulatory and quality teams
- Constant updates to procedures and documentation
What This Means for Pharmaceutical Companies
The new framework increases efficiency but also raises technical and operational demands.
The challenge is no longer to renew the license, but to keep it valid, ensuring that every product-lifecycle stage meets regulatory standards.
Aligned with regional trends in administrative simplification and stronger health surveillance, companies must develop a proactive compliance culture and manage portfolios with a long-term vision.
Keys to Strengthen Regulatory Management
- Review notification and variation procedures
- Reinforce documentation, traceability and internal controls
- Train teams and monitor active portfolios
Toward Sustainable Regulatory Management
The transition to indefinite marketing authorizations marked a milestone in Colombia’s regulatory modernization but also redefined industry responsibility.
Success now depends on the ability to sustain technical and documentary compliance over time.
Companies adopting a strategic and preventive approach will be better prepared to maintain market continuity and strengthen their reputation before INVIMA and other stakeholders.
At Freyr, we support pharmaceutical organizations in end-to-end regulatory lifecycle management, from initial approval to continuous maintenance under indefinite validity schemes.
We combine regulatory intelligence, technical expertise, and strategic compliance to help companies interpret regulatory contexts, adapt to change, and transform challenges into sustainable competitive advantages.
Connect with our experts to assess your portfolio maturity and design a regulatory strategy tailored to your operations in Colombia.
