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2 min read
Before a medicine reaches patients in Colombia, there is one step no company can skip: obtaining marketing authorization from INVIMA. More than just a formality, this process is the starting point for legally, safely, and strategically entering the Colombian market.
In this blog —part of the LATAM Essentials series— we break down the fundamentals: how INVIMA classifies medicines, what your technical dossier must include, how to use the Single Window for Procedures platform, and what to expect after approval.
🧰 Drug classification and regulatory pathways
INVIMA groups drugs into three risk categories: high, medium, and low. This classification determines the evaluation level, required documentation, and whether the product qualifies for an abridged pathway.
- High-risk products (new molecules, biologics, innovative combinations) require full evaluation.
- Medium- or low-risk medicines (such as generics or similar drugs) may access simplified pathways if they meet predefined criteria.
📂 What should the technical dossier include?
The dossier should preferably follow the CTD (Common Technical Document) format. This ensures a structured submission aligned with international standards and facilitates future filings in other markets.
The dossier must include:
- Module 3 – Quality: Composition, manufacturing process, method validation, quality controls, specifications, and stability data.
- Module 4 – Non-clinical studies: Pharmacological and toxicological information in animals (when applicable).
- Module 5 – Clinical studies: Human trials, bioequivalence (if applicable), and risk-benefit assessment.
Additionally, companies must submit:
- Official application forms
- Proof of fee payment
- Valid GMP certificate (local or internationally recognized)
- Certificate of Pharmaceutical Product (CPP), if applicable
- Legal representative’s power of attorney
- Company background documentation
🌐 Digital submission to INVIMA: Single Window for Procedures
Applications must be submitted via INVIMA’s official Single Window for Procedures platform. This digital system enables:
✔️ Uploading legal and technical documents ✔️ E-signing official forms ✔️ Online fee payments ✔️ Real-time tracking of submission status
INVIMA prioritizes use of this platform. Paper submissions are accepted only in exceptional cases.
⏳ Technical review and approval
Once the application is submitted, INVIMA assigns a multidisciplinary technical team to evaluate the information based on the product’s risk level.
Evaluation timelines vary but generally range from 120 to 180 business days. Priority products, such as those for orphan diseases or public health needs, may follow accelerated pathways.
The granted marketing authorization is valid for five years and must be renewed to maintain commercialization rights in Colombia.
📈 Post-approval obligations and oversight
Any post-approval changes (formulation, packaging, manufacturer, marketing authorization holder, etc.) must be approved by INVIMA before implementation.
The holder must also comply with pharmacovigilance obligations, including safety reporting and participation in post-marketing surveillance programs.
🤝 How Freyr supports you in Colombia
At Freyr Solutions, we help pharmaceutical and life sciences companies navigate the Colombian regulatory landscape from end to end. Our local team provides:
- Preparation, review, and validation of CTD dossiers
- Regulatory strategy based on product risk level
- Legal representation before INVIMA
- End-to-end support on the Single Window for Procedures platform
- Guidance on pharmacovigilance and post-approval changes
With regional presence and technical expertise, we guide you through each step of the process to secure an approval fully aligned with INVIMA's requirements.
Ready to take your regulatory strategy to the next level?
Contact our experts and chart a clear path toward successfully approving your products in Mexico.
