The National Institute of Food and Drug Surveillance (INVIMA) is a Regulatory authority established by the Colombian Ministry of Health to regulate and oversee foods, medications, medical equipment, pharmaceuticals, and biological goods.
The following steps are involved in registering a pharmaceutical product with INVIMA in Colombia:
- Prepare and Submit a Dossier: The applicant is responsible for preparing and submitting a dossier to INVIMA. If new molecules are discovered, a new molecular committee review will be conducted.
- Determine the Product's Categorization: Determine the product's classification using INVIMA's classification criteria.
- Appoint a Colombian Legal Representative: A Colombian Legal Representative should be appointed to manage the product registration and contact INVIMA on the applicant's behalf. A qualified importer may also file the registration, but they must designate themselves as the registration's owner.
- Create a Registration Application Dossier for Submission to INVIMA: The dossier should include product information as well as the product's commercial history. Class IIa, IIb, and III devices will require test reports, while Class IIb and Class III devices will require clinical data. Submit these materials in Spanish to INVIMA, together with the mandatory application fee.
- Review and Approval: Once the application is submitted, INVIMA will analyze the dossier and provide a registration certificate if the application is granted. An application is typically reviewed in eight (08) months. In Colombia, however, the clearance time for new pharmaceutical medicines is between twelve (12) and eighteen (18) months. If INVIMA asks for additional information or evidence during the review process, the applicant usually has ninety (90) days to supply the requested material.
It is crucial to remember that the approval process can be difficult and time-consuming, and the actual approval time may vary depending on factors such as the product's complexity, the completeness of the application dossier, and the Regulatory authority's workload.
Do you want to register a pharmaceutical product with INVIMA? Our Regulatory affairs specialists can guide you through the process and guarantee that your application is comprehensive and accurate. To learn more about our Regulatory services, please contact us today.