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Medicinal Products Regulatory Support in Colombia – Overview
Colombia is Latin America’s third-largest pharmaceutical market, following Brazil and Mexico, making it a key hub for healthcare growth. A key driver behind Colombia’s attractiveness is its universal healthcare system, which ensures broad health insurance coverage for the population. This wide access to healthcare creates strong demand for medicines, making it an appealing market for companies focused on both Rx and OTC products. INVIMA oversees registration, clinical trials, GMP inspections, and market surveillance for medicines, biologics, and vaccines. Market entry requires a clear Regulatory strategy, Spanish-language dossiers, a local MAH/representative or license, and GMP compliance. Freyr offers tailored services to streamline submissions and accelerate time to market.
Medicinal Product Classification in Colombia
Medicinal products in Colombia are classified by the Regulatory agency INVIMA based on their risk profile, therapeutic value, and Regulatory pathway, using clear categories for medicines.
Main Classification for Medicines
Medicinal products are grouped by INVIMA into three risk categories:
High Risk: Includes new molecules, biologics, or innovative combinations requiring full Regulatory evaluation.
Medium Risk: Covers some prescription medicines such as generics and similar drugs, which may be eligible for accelerated or simplified Regulatory pathways.
Low Risk: Encompasses over-the-counter products and drugs deemed to pose minimal risk to patients.
There is also a product class system:
- Class A: Over-the-counter painkillers and minor drugs.
- Class B: Prescription medicines, e.g., antibiotics.
- Class C: Drugs considered high-risk, e.g., immunosuppressants.
This classification system helps INVIMA determine the level of Regulatory scrutiny each product requires, ensuring that higher-risk medications undergo more rigorous evaluation processes to guarantee safety and efficacy.
Medicinal Product Drug Registration & Approval
Registering a medicinal product in Colombia requires compliance with the regulations set by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the National Institute for Food and Drug Surveillance. Below is the complete registration and approval process.
1. Establishment License
Before initiating product registration, manufacturers or importers must obtain an establishment license from INVIMA. This license ensures adherence to Good Manufacturing Practices (GMP) and is a prerequisite for product registration.
2. Appoint a Colombian Legal Representative
Foreign entities must designate a legal representative in Colombia to handle interactions with INVIMA and manage the registration process.
3. Prepare and Submit the Registration Dossier
The registration dossier should include:
- Product technical dossier
- Manufacturing process details
- Clinical trial data (if applicable)
- Proof of GMP compliance
- Labeling and packaging information
Module 1 documents must be submitted in Spanish.
4. Product Classification
INVIMA classifies pharmaceutical products based on their risk level. The classification determines the documentation requirements and approval timelines.
5. Review & Approval
The review process duration varies:
- The review process duration for medicinal products is around 2 – 3 years.
- No renewal is needed for Medicinal Products (Biologics & Generics).
Registrations are typically valid for 5 years.
6. Post-Approval
After obtaining approval, manufacturers must adhere to post-market surveillance requirements, including reporting adverse events and renewing registrations as necessary.
Ensure your medicinal product meets all Regulatory requirements to enter the Colombian market efficiently.
Freyr Expertise – Colombia Regulatory & Strategic Support
Freyr provides comprehensive Regulatory services tailored to Colombia and the broader Latam region:
- Dossier preparation and submission to INVIMA
- Regular follow-up and query management until product approval
- Gap analysis, remediation planning, and Regulatory strategy consultation
- GMP compliance support
- Authorized local representation in Colombia
- Regional language translation and validation
- Liaison and pre-submission consultations with INVIMA
- Regulatory intelligence and strategic guidance
- Management of variations, site transfers, MAH transfers, and license renewals