The process for obtaining a medication’s Marketing Authorization in Colombia begins with the Market Authorization Application (MAA).
Medications’ Market Authorization (MA) can be obtained for new, and medicines already included in the Colombian Pharmacological Code (CPC). A registration certificate is issued by the sanitary agency INVIMA. This certification grants the holder the right to profit from the commercial activity and enables the state to control the quality and safety of the medicines offered to the public.
For new medications, a pharmacological evaluation must be initially requested. The Medications Reviewing Committee undertakes the task of diagnosing the efficacy and safety measures. This includes a review of the indications, contraindications, interactions, precautions, warnings, pharmacokinetics, pharmacodynamics, dose, risk-to-benefit ratio, adverse events, immunogenicity, and special restrictions.
Innovative medicine already approved by two or more reference countries (i.e., USA, Canada, Germany, Switzerland, France, U.K., Denmark, Netherlands, Sweden, Japan, Norway) and not rejected by other reference countries, may be subjected to an abbreviated pharmacological evaluation (Decree 677/1995).
For biosimilar products, an abbreviated route requiring no clinical trials, nor head-to-head comparability assays for safety and efficacy demonstration is available. Despite this, immunogenicity assays and characterization of the active pharmaceutical ingredient (API) and the manufacturing process are required (Decree 1782/2014).
Manufacturing plants with no Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP) certificate, from a reference country or issued by the FDA, WHO/PAHO, or EMA, must undergo on site GMP inspection by INVIMA. This step takes place before the dossier technical and legal evaluations.
Following the approval of the pharmacological evaluation, new medications are included in the CPC. MAA involving pharmaceutical and legal evaluations, may be subsequently filed. The legal evaluation focuses on the legal documentation filed by the applicant according to pertaining regulations.
To obtain a MA for a medication that is already included in the CPC (except for biological products), generic applicants may proceed directly to filing the MA application (subject to the product´s pharmaceutical and legal evaluation).
Registration certificates issued by INVIMA are valid for five years.
Conclusion
The process for obtaining a medication’s Marketing Authorization in Colombia contains multiples steps and varies depending on the type of medication, if it’s recognized by the CPC, the review of the Medications Reviewing Committee, Manufacturing plant GMPs recognition, approval by other National Health Authorities (NHA), and the legal evaluation. Getting support from a local pharmaceutical company with experience in the application process is highly recommended.
Zonepharma is a pharmaceutical wholesaler company that specializes in innovative prescription medications. It has successfully registered more than 25 medications in the Colombian market and acquired leading market share positions.
If you want to learn more about our MAA service or have a business inquiry, you can contact us using the contact form.
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