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Colombia Drug Product Registration

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Colombia Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH

Ministry of Health and Social Protection of Colombia

MoH Website

https://www.minsalud.gov.co/English/Paginas/inicio.aspx

Regulatory Agency

The National Institute of Drug and Food Surveillance (INVIMA)

Regulatory Agency Website

https://www.invima.gov.co/

Local Authorized Representative

Yes

Pharmaceutical Product Classification

Class A: Over the counter Pain Killers.

Class B: Prescription Antibiotics.

Class C: High risk Medications like immunosuppressants.

Overview

  • The Colombian Ministry of Health established the National Institute of Food and Drug Surveillance (INVIMA) as a regulatory body to control and monitor food products, medicines, medical supplies, medical equipment, and biological products.
  • INVIMA plays a crucial role in maintaining the efficacy, safety, and quality of healthcare products.
  • It oversees vital tasks including processing registrations, monitoring clinical studies, and carrying out post-market surveillance.
  • Manufacturers and importers of medicines and medical devices into Colombia are required to appoint a Local authorized representative. This representative acts as a bridge between the companies and the regulatory authorities, ensuring compliance with regulations and facilitating communication.

Clinical Trial Requirements

  • The national regulatory agency for drugs and medical devices in Colombia, INVIMA, has a rigorous approval process for clinical studies.
  • These studies must adhere to ethical and scientific standards to ensure patient safety and reliable results.
  • Informed consent forms and research protocols, among other detailed documents, are essential for the effective start and conduct of clinical trials in the nation.

Testing Requirements

Pharmaceuticals and medical devices go through a rigorous testing procedure to make sure they are safe and effective for usage. Numerous significant components are tested in these examinations, such as toxicity studies, performance, stability, and biocompatibility.

Foreign Testing and Recognition

Foreign testing data is typically accepted in Colombia, however there may be extra requirements like validation and translation. Notably, Colombia frequently accepts testing results from nations like the United States (US) and the European Union (EU).

Labelling Requirements

It is important that medications and medical devices in Colombia provide all relevant information on their labels. This contains the name of the product, the manufacturer’s information, usage guidelines, crucial safety advice, and regulatory data. For users to communicate and comprehend this information effectively, it must be offered in both Spanish and the local tongue.

Pre-registration Requirements

Before they can register their products in Colombia, producers and importers of pharmaceuticals or medical devices must first get an establishment license from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Obtaining this license is a crucial step in making sure that good manufacturing practices (GMP) are followed. Getting this license proves that the importer or producer is dedicated to upholding strict production guidelines and providing reliable products for the Colombian market.

Registration Process

  1. Preparation and Submission of Dossier

The dossier is prepared and submitted to INVIMA by an applicant. If new molecules are discovered, a new molecular committee review will be conducted.

  1. Determining the Product’s Categorization

Apply the INVIMA classification criteria to determine the product’s categorization.

  1. Appointing a Colombian Legal Representative

A Colombian Legal Representative should be appointed to manage the product registration process and communicate with INVIMA on their behalf. The registration may also be submitted by a qualified importer, but they must identify as the register’s owner.

  1. Create a Registration Application Dossier for Submission to INVIMA

Information on the product and its commercial history should be included in the dossier. These materials, together with the required application fee, should be submitted in Spanish to INVIMA.

  1. Review and Approval

Once the application is submitted, INVIMA will review the dossier and provide a registration certificate if the application is approved.

  • Usually, the application is reviewed in eight 08months.
  • Clearance time for new pharmaceutical medicines: 12-18 months
  • If INVIMA requests additional information or supporting documentation during the assessment process, the applicant typically has ninety (90) days to provide it.

Accelerated Approval based on EU/US Approval

  • Getting a product approved in the US or the EU can make the Colombian registration procedure much easier.
  • This is because these jurisdictions are known for having strict laws and regulations.
  • A product that has previously received approval in the US or the EU means that it has passed stringent safety and effectiveness testing and has undergone a comprehensive examination.

Import and Distribution Requirements

  • Getting an import license from the National Institute for Food and Drug Surveillance (INVIMA) is a requirement for importers operating in Colombia.
  • Importers may enter the nation lawfully with this license. Furthermore, Colombian distribution centers are required to follow Good Storage Practices (GSP).
  • These procedures preserve the integrity and quality of goods while they are being transported and stored.

Documents Required for Product Registration in Colombia

  1. Product technical dossier
  2. Manufacturing process details
  3. Clinical trial data
  4. Proof of GMP compliance
  5. Labelling and packaging information
  6. GMP Inspection Requirements:
  7. Manufacturers and facilities are subject to GMP inspections by INVIMA to ensure compliance with manufacturing standards.

Fees

  • Drug Product in the Pharmacological Code: $3,200
  • New drug: $7,000
  • Biological Products: $7,238
  • Good Manufacturing Practice Certificate: $12,035 USD.

Post Marketing Activities

  • Pharmacovigilance is continuous monitoring and documentation of any adverse events that could be associated with a pharmaceutical product.
  • The process of proposing modifications to items that have previously received approval, such tweaks to their production procedures, is known as variations.
  • The term “renewal” describes the recurrent renewal of product registrations to guarantee they continue to adhere to legal requirements.
  • To ensure continued compliance with requirements, audits of manufacturers and importers may also be conducted.

Registration Approval Timeline and License Validity and Renewal

  1. New drug products, included in Colombian pharmacological norms, foreign manufacturing.
  • Approval timeline: 80 days
  • License Validity: 5 years
  • Renewal period: 3 months before expiration date.
  1. New drug products, included in Colombian pharmacological norms, national manufacturing:
  • Approval timeline: 200 days
  • License Validity: 5 years
  • Renewal period: 3 months before expiration date.
  1. Simplified product registration procedure, for simple homeopathic drug products, national or foreign manufacturing.
  • Approval timeline: 40 days
  • License Validity: 10 Years
  • Renewal period: 3 months before expiration date.
  1. Non-simplified product registration procedure for homeopathic drug products, and complex homeopathic drug products, national manufacturing.
  • Approval timeline: 190 days
  • License Validity: 10 Years
  • Renewal period: 3 months before expiration date.
  1. Non-simplified product registration procedure for homeopathic drug products, and complex homeopathic drug products, foreign manufacturing.
  • Approval timeline: 190 days
  • License Validity: 10 Years
  • Renewal period: 3 months before expiration date.

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