Measures for the Diagnostic Prevention and Treatment of COVID-19
March, 2020 - Juan Cadena, Martin Torres
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19
The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygiene and personal hygiene required for the prevention, diagnosis and treatment of COVID-19, as stated below:
- • Evaluation of the Sanitary Registration Application, Marketing Permit and / or mandatory sanitary notification.
- • Requirements to be met by the manufacturers of the aforementioned products.
- • Marketing, distribution, sale, unreported delivery, storage and transportation.
- • Requirements for the authorization pharmaceutical service in establishments that are required for the prevention, diagnosis or treatment of COVID-19.
- • Requirements for donations of the products.
- • Requirements to be met by importing establishments to obtain the certificate of storage and / or conditioning (CCAA) of Medical Devices, biomedical equipment and diagnostic reagents.
- • All the aforementioned products are declared of public health interest.
- • Establish measures to mitigate the eventual shortage of the mentioned products.
INVIMA has the authority to perform the following activities:
- • Include as Non-available Vital supplies all the necessary products for the prevention, diagnosis and treatment of COVID-19.
- • To process as a priority the requests for new health records or marketing permits and renewals of medicines that are in pharmacologica l list, phytotherapeutic products and medical devices whose risk classification is IIB and III that are required for prevention that are required for prevention. , diagnosis and / or treatment of the Covid-19, or those determined as first line, accessories or special.
- • Accept, approve or validate the minutes that grant Good Manufacturing Practices issued by PIC-S agencies, in all the necessary procedures.
In addition, during the term of the health emergency declared by the Ministry of Health and Social Protection, the apostille or consularization requirements of the documents required for the procedures for granting health records, marketing permits, mandatory health notifications, authorization of donations or vital products not available, and their associated procedures, as appropriate, for medications, phytotherapeutic products, medical devices, biomedical equipment, in vitro diagnostic reagents, cosmetics and household hygiene products and personal hygiene absorbents that are required for the prevention, diagnosis or treatment of Covid 19 will no longer be requested.
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