Overview:

The National Institute for Food and Drug Surveillance – Invima (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19. New procedures & services in charge of the entity are added including those that were suspended and those relevant to process of reactivation of productive sector following the national government regulations.

Colombia’s regulatory agency have been adopting measures to mitigate the risks and are working hard to come up with a plan to efficiently operate and maintain safety for the public while giving the public safe and effective drugs and devices in this pandemic.

Biological Products and Medicines Directorate

The following modifications are made to advance procedures and actions:

  1. Requests for authorization of manufacture, production and / or import of medicines and / or products declared as vital not available.
  2. Free sale certificates.
  3. Applications for homologations and validations of Good Manufacturing Practices (BPM) within the procedures related to COVID-19.
  4. Products based on Cannabis, Phyto therapeutic, homeopathic and dietary supplements, including those that are brought before the respective Specialized Room.
  5. Research protocols and associated procedures.
  6. OTC advertising authorizations for over-the-counter medicines, herbal and homeopathic products and all dietary supplements.
  7. Automatic renewals and modifications of chemical synthesis drugs.
  8. VAT exclusion procedures.
  9. The scheduling and implementation of virtual or mixed Good Practice Certification visits, of requests filed before the entry into force of resolution 2020012926 of April 03, 2020.

Medical Devices Directorate

As per the Act 3 of the specialized room for medical devices and/or biomedical Equipment auto responses, replenishment resources, response to suspensions, fixes and notification of administrative acts are to be managed in indicated procedures. Reactivating procedures are:

  1. Modifications of sanitary registry and marketing permits
  2. Product and advertising exhaustion authorizations
  3. Marketing Permit Applications for Controlled Technology Biomedical Equipment
  4. Storage and Conditioning Capacity Certification Visits
  5. Certification and visit in sanitary conditions for tissue and bone marrow banks
  6. Certification and visit in Good Practices for tissue and bone marrow banks
  7. Verification visit of Good Practice requirements for tissue banks
  8. Verification visits to temporary tissue storage centers
  9. Reproductive biomedical units’ sanitary requirements verification visits, semen banks and all other anatomical component banks
  10. Procedures of the Specialized Room for Medical Devices and In Vitro Diagnostic Reagents

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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