Steps for product registration:
1- Download or request registration solicitude form from website.
2- Pay the applicable fee through electronic bank transfer or at an affiliate of the Davivienda bank.
3- File the registration application at INVIMA’s Oficina de Atención al Usuario (Customer service office) including all the applicable documents. (see below)
4- Redeem the notice issued by the entity.
The official timeline for approval is of 80 days, and the period of registration if of 5 years. (Application for renewal of the marketing authorization must be submitted at least 3 months before the expiry date of the registration) It is possible to follow up on the status of the case via telephone, internet at www.invima.gov.co or personally at the INMIVA office.
1. Request form, signed by empowered or legal representative of solicitor or owner, and including the name of the product, brand (if applicable), name of owner, name of manufacturer, category and statement confirming that the legal and technical information provided is accurate. (Original)
2. GMP certificate from country of origin, if the manufacturer hasn’t been visited by INVIMA (Copy). The validity of this document will be the one stated in it, otherwise it will be set at 1 year.
3. Certificate of existence and legal representation of the solicitor, manufacturer(s), importer(s) and/or packager(s) issued within the last three months (Copy).
4. Power of attorney authorizing representative to file the application (Copy).
5. Certificate issued by the Superintendencia de Industria y Comercio, stating that the brand is registered on the name of the solicitor or that its registration has been requested and is under processing. When the owner of the brand is not the solicitor, authorization for use from the owner must be attached (Copy).
6. Receipt or proof of electronic transfer of the applicable fee (Copy)
7. CPP of origin, compliant with the requirements of Decreto 426 de 2009. The validity of this document will be the one stated in it, otherwise it will be set at 1 year. (Copy)
8. Express authorization from manufacturer or owner to importer, to request marketing authorization, use the brand and commercialize the product, if applicable (Copy).
9. Pharmaceutical form and comercial presentations of the drug product.
10. Composition or quantitative formula, divided in two sections: API and excipients.
11. Structural and condensed chemical formula of APIs.
12. Manufacturing batch formula.
13. Detailed description of manufacturing process.
14. Analytical methods, in accordance to pharmacopoea or properly validated, and validation reports for non-pharmacopoeial methods.
15. Summary of pharmacological information.
16. Stability studies and shelf life, based on international standards such as ICH or official pharmacopoeias.
17. If indicated by the Comision Revisora (Revision Commission), results of bioavailability and bioequivalence studies.
18. Quality specification for raw materials.
19. Quality specification for product-in-process.
20. Quality specification for the finished product.
21. All labeling material: packaging, labels, leaflets, etc.