1. Declaration of products as Vital Unavailable.
Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available. This means that their entry into the country would be authorized without the need for said products to have a Sanitary Registry issued by INVIMA. To proceed with the import, the interested party must submit the following documents:
- Free sale certificate or certificate adjusted to the requirements established by the World Health Organization (WHO), for products subject to international trade, duly apostilled or consularized and legalized
- IUM number and/or application number
- Certificate of incumbency and good standing of the applicant
- Analysis certificate
- Justification of the requested quantity
The import authorization of products, supervised by Invima, required to attend the public health emergency, is being carried out through the Single Window for Foreign Trade (VUCE), reducing the processing times from six (6) days to one (1) business day, additionally, a direct communication channel has been established for the exchange of information in order to attend the problems caused by the SARS-CoV-2.
2. Electronic communication channels
The authority opened electronic communication channels for some requests, such as:
- Notification of administrative decisions
- Annexes to the file, complementary briefs.
- Request for cancellation or loss of enforcement power
- Requests for rectification of decisions
- Ex officio reviews
- Responses to petitions or requirements
- Rights of petition
3. Streamlining of procedures related to products necessary for diagnosis, treatment and support of patients with COVID-19
All procedures related to COVID-19 diagnostic reagents in vitro, commercial kits for real-time molecular methodology (RT-PCR), cosmetics and absorbent personal hygiene products that are required for the prevention, diagnosis and/or treatment of infection, allowing its manufacture and importation deprived of sanitary registration, avoiding shortages in the country.
As for the procedures for new applications for sanitary registrations and medication renewals that are in pharmacological standards and medical devices, whose risk classification is IIb and III required for prevention or diagnosis of COVID-19, they have also been classified as priorities, streamlining processes for approval.
4. Expedite Analysis of Research Protocols
The authority communicates the necessary requirements for the presentation of initial protocols that may contribute to obtaining information on possible therapeutic alternatives for the management of COVID-19, which may be filed electronically by sending the information by email: invimabpc@invima.qov.co.
- Parallel evaluation of the Ethics Committees and lNVIMA will be allowed exceptionally and only for this type of protocol.
- The GIC agrees to evaluate the protocol within 5 days as of the filing of the application and issue the corresponding administrative decision.
- Should requirements be issued by the GIC, the interested party must commit to answering them as a priority within the following 5 days in order to accelerate their approval.
- Once all the requirements have been met by the interested party, the GIC agrees to issue the corresponding administrative decision within 48 hours