Type of Intervention: Specific Action
Sectors Involved: Health, Private Sector and Businesses
Level of Jurisdiction: National
Lead People/Agency: Decision made by President and Cabinet of Miisters
Leading of the implementation of the intervention: the Ministry of Health and the National Institute for drugs and food surveillance (INVIMA for its name in Spanish)
Overview: Measures aimed at guaranteeing the prevention, diagnosis and treatment of Covid-19 are dictated and other dispositions are dictated, within the State of Economic, Social and Ecological Emergency.
1.1 Make flexible the requirements for the evaluation of applications for health registration, marketing authorization or mandatory health notification, as appropriate, for medicines, phytotherapeutic products, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics and household hygiene products and absorbents for personnel that required for prevention, diagnosis or Covid-19 treatment.
1.2. Make flexible the requirements that establishments that manufacture drugs, phytotherapeutic products, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics, and household hygiene products and personal hygiene absorbents require the prevention, diagnosis or treatment of Covid-19.
1.3.Flexibilize the basic requirements for the commercialization, distribution, dispensing, unreported delivery, storage and transportation, medicines, phytotherapeutic products, medical devices, biomedical equipment, in vitro diagnostic, cosmetic and household hygiene products and personal hygiene absorbents that are required for the prevention, diagnosis or treatment of Covid-19.
1.4.Flexibilize the requirements for the pharmacist’s authorization in the establishments that are required, for the prevention, diagnosis or treatment of Covid-19.
1.5 Flexibilize requirements for donations of medicines, phytotherapeutic products, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics, and household hygiene products and personal hygiene absorbents that are required for Covid-19 prevention, diagnosis or treatment.
1.6. The importing establishments must comply with the requirements to obtain the Certificate of Storage and / or Conditioning (CCAA) for medical devices, biomedical equipment, and in vitro diagnostic reagents.
1.7. Declare of interest in public health the medicines, medical devices, vaccines and other health technologies that are used for the diagnosis, prevention and treatment of COVID 19.
Full details here: https://coronaviruscolombia.gov.co/Covid19/docs/decretos/minsalud/113_decreto_476.pdf
Type of Justification: Advice of INTERNAL government advisory committee or group, Advice of EXTERNAL expert advisor or advisory committee
Source of Evidence or Justification: National – government, National – other, Pharmaceutical, medical devices and in vitro reagents industry
Evidence/Justification: There is a standardized administrative procedure applied by INVIMA for the granting of health records and marketing permits, through which the entry into the country of: medical devices, such as face masks and other medical supplies; biomedical equipment such as ventilators for intensive or intermediate care of patients with compromised respiratory system; in vitro diagnostic reagents, which are used for the diagnosis of diseases, including Coronavirus COVID-19; and cosmetics and household hygiene products and personal hygiene absorbents, among which are antibacterial gels,
The administrative procedure that allows entry into the national territory takes between ninety (90) days and six (6) months, depending on the product in question, which is excessive time to allow the commercialization in the country of new diagnostic reagents for detect the Coronavirus COVID-19 or drugs for the treatment of the disease, either new drugs or new indications for existing drugs, which are not registered in Colombia, since they have been developed worldwide as to the evolution of the pandemic. For this reason, an expedited procedure is required to fill the aforementioned procedures and facilitate their availability in the country, given the expected growth of Coronavirus COVID-19.
The demand for medical devices and other products such as gloves, face masks, antibacterial gel, cleaning products, and others, has increased substantially as a result of the pandemic, so it is necessary to adopt mechanisms to facilitate their importation or local manufacture to supply the increased demand. caused by Coronavirus COVI 9 ..
The relaxation of these requirements and administrative procedures does not ignore the fundamental right to a decent life and health of all the inhabitants of Colombia, what they seek is to guarantee availability, accessibility, equity. continuity and opportunity of the health service.