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 200 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. Supporting letter from Pharmaceutical Chemist – Technical Director of manufacturing lab or company. (Original)
2. Composition or quantitative formula, divided in two sections: API and excipients (Per dosing unit, in cases of dosified presentation such as tablets, capsules, ovules, suppositories, inyectable forms, etc. Or per 100 milliliters for liquid, non-inyectable forms. Or per 100 grams, for powders, ointments, creams or similar. Or per grams of reconstitutable powder. Or in percentage of weight or volume, indicated separetly the APIs, solvents and impulsing gases for aerosols.).
3. Structural and condensed chemical formula of APIs.
4. Detailed description of manufacturing process.
5. CoA of reference substances used for the quality control of APIs.
6. Quality specifications and CoAs of raw materials.
7. Quality specifications, analytical methods and CoAs of product-in-process.
8. Quality specifications and CoAs of the finished product.
9. Analytical methodology of the finished product. If its coded in one of the accepted pharmacopoeias, indicate pharmacopoeia, edition and page number. If not coded in pharmacopoeia, include complete validation reports. For solid pharmaceutical forms, when the API is coded in several pharmacopoeias, and if the chosen pharmacopoeia doesn’t include the dissolution test, the dissolution test coded in the USP will be required.
10. Scaled color draft of labeling and packaging materials.
11. Summary of pharmacological information including administration route, dosing and frequency of administration, pharmacologic indications, therapeutic use, contraindications, adverse reactions and warnings.
12. Stability studies and shelf life of the drug product.
13. Pharmaceutical form and commercial presentations of the finished product.
14. 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)
15. Manufacturing contract, in the case that the product is manufactured by a third party. The contract must specify the manufactured products, steps of manufacturing performed and if the third party will conduct the quality testing (Copy).
16. Certificate of existence and legal representation of the solicitor and/or manufacturer(s), issued within the last three months (Copy).
17. Power of attorney authorizing representative to file the application (Copy).
18. 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).
19. Receipt or proof of electronic transfer of the applicable fee (Copy)