INVIMA Requirements for Registration of a Pharmaceutical Drug in Colombia
A registration certificate from INVIMA is required to obtain operating licences for marketing authorization (MA) for new medicines and for medicines already included in the Colombian Pharmacological Code.
To obtain MAs for new medicines, the applicant must first submit a pharmacological evaluation application. The pharmacological evaluation studies the safety and efficacy of the drug and is performed by the Medicines Reviewing Committee, which takes into account the following features: efficacy, safety, dosage, indications, contraindications, warnings, toxicity, trading conditions and restrictions. Alternatively, article 27, paragraph 1 of Decree 677 provides an abbreviated procedure for innovators by means of which INVIMA can forego conducting a pharmacological evaluation (safety and efficacy) of a product whenever such product is already approved in at least two reference countries and has not been rejected in any of the other reference countries. Furthermore, article 72 of the National Development Plan (Law 1753 of 2015) now also requires an additional economic (cost/benefit) evaluation to be performed (by the IETS) in parallel to the pharmacological evaluation. However, regulations of article 72 are still under development, which is why this economic evaluation is not yet being applied.
Regarding biological and biotechnological products, a pharmacological evaluation must be performed even if the active ingredient (drug substance) is already included in the Colombian Pharmacological Code. This evaluation assesses the efficacy (indications, contraindications, interactions, precautions, warnings, pharmacokinetics, pharmacodynamics, dose, risk-to-benefit ratio) and safety (adverse effects, immunogenicity, trading conditions, special restrictions and risk-to-benefit ratio). Specific requirements for the submission of information for pharmacological evaluation are detailed in Decree 1782. This Decree contains an abbreviated route, by means of which biosimilar products should not have to submit clinical trials, nor head-to-head comparability assays to demonstrate their safety and efficacy. This route has been questioned by biotech R&D manufacturers and sanitary authorities worldwide. Mandatory immunogenicity assays and a perfect characterisation of the API and its manufacturing procedure will be required to applicants even if they choose the abbreviated route.
Once the pharmacological evaluation is approved, the new medicine is included in the Colombian Pharmacological Code (when not previously included, in the case of biologicals). Subsequently, an MA application can be filed, which involves a pharmaceutical and a legal evaluation.
The pharmaceutical evaluation evaluates the capabilities of the manufacturing process and the product’s quality (chemistry manufacturing and controls). The legal evaluation focuses on the legal documentation filed by the applicant, in compliance with the regulations governing this matter.
Finally, to obtain MAs for medicines already included in the Pharmacological Code (excluding biological products), generic applicants can proceed directly to filing the MA application (limited to the pharmaceutical and legal evaluation of the product). Decree 2085 of 2012 provides for regulatory test data protection, and a generic applicant is blocked from pursuing approval for five years when this protection exists.
List of Requirements
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. Certificate of pharmaceutical product (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. 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.
Source: INVIMA (in Spanish)
- 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 expiration date of the registration.
- All documents must be translated to the "Colombian" Spanish dialect. The Spanish spoken in Latin America changes from country-to-country. Just like there are differences in English expressions, spelling, industry and business terminology among English-speaking countries (USA, UK, Australia, Canada, etc.) Spanish varies throughout Latin America. Colombian Spanish has its own peculiarities just like Mexican or Argentinian Spanish have. For Colombia’s INVIMA purposes, this is important since the evaluation committee members should be able to easily understand the dossier file that we submit for approval.
- We recommend that sponsors translate their documents by Colombian Spanish-speaking translators certified by the Colombian Ministry of Foreign Affairs.
- A certified translator is a person who has passed the linguistic proficiency test from the relevant agency designated by the Government of Colombia for this purpose. Any translator who passes this test should take office before the Superior Tribunal of the Judiciary District and apply for a certification from the Ministry of Justice and Law, which will accredit him or her as an official certified translator. The certified translator must register his name with the Ministry of Foreign Affairs by submitting a copy of the Oath of Office and a copy of the certification issued by the Ministry of Justice and Law.
- LATAM Market Access Inc. offers its customers certified translation services and works with local Colombian certified translators duly endorsed by the Ministry of Foreign Affairs (who therefore, hold the relevant certification issued by the Ministry of Justice and Law) with past experience with regulatory affairs. This will ensure that our sponsor's translations as accurate, faithful and valid to be presented to any government agency such as INVIMA.
- Although INVIMA doesn’t specifically require that sponsors submit documents translated to Spanish by official government-certified translators, it’s customary —and expected by the recipient of the document— in Colombia that all translations (both in private business and government dealings) are done by government-certified translators.
- A printed document that has been translated by a certified translator in Colombia will have (by law) the following elements:
- A "Certified Translation" header.
- A consecutive certified translation control number.
- The seal of the official translator in which the translator's full name, his or her certification number issued by the Ministry of Justice, the certification issue date, and the languages that the translator is certified to translate.
- The signature of the translator in the last page, or at least, the initials of the translator if the document has several pages.
- Through a seal and a signature, the translator certifies that the translation is correct and complete and takes responsibility for what is translated. This way, the translator basically acts like a notary authenticating a document. A certified translator is also authorized to be an official interpreter, translating declarations and affidavits before a notary or a judge.