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The Minister of Health, Fernando Ruiz, announced this Monday that he signed the decree that allows the delivery of health licenses for emergency use of medicines and vaccines in the context of the health emergency for covid-19.
(Also read: Covid-19 patients in ICU have grown by 50 percent in December)
This decree, which for the first time allows measures of this type, explained the minister, seeks streamline the processes and procedures to achieve approval by the health authority, in this case Invima, of the covid-19 vaccines that should begin to be applied in February in Colombia and other products that are in advanced stages of research.
According to President Iván Duque, with this decree the pharmaceutical companies with which the Government has already negotiated the purchase of 20 million complete vaccines as well as others with which talks are underway will be able to submit their applications for health licenses for emergency use in the country.
(Also: AstraZeneca announces having ‘the winning formula’ in the coronavirus vaccine)
Ruiz indicated that the decree does not open the way for lightly approval of these vaccines, but rather Invima will be able to do it in less time, exactly in maximum 20 days, as established in the document.
During this period, Invima will analyze the documents of the scientific studies presented by pharmaceutical companies and in which conditions of quality, safety and efficacy for patients are certified.
Equally, The decree establishes sufficient traceability so that the health authorities can follow the possible adverse effects presented by the patients receiving the vaccines.
(We recommend: Only half of Colombians would get the covid-19 vaccine)
Within what is signed, it is contemplated that the potential vaccines may be approved in advanced phases of research and once the studies are completed, the applicants must provide full information on the drugs.
“The regulation requires the presentation of a risk management plan, which obliges drug producers to provide data so that Invima can carry out pharmacovigilance of adverse effects and the immediate report to follow up,” said Ruiz.
Vaccines and medications that receive this authorization will have one year of emergency use, which can be renewed only once.
(You may be interested: Why did Mexico and Chile already started vaccination and Colombia in February?)
HEALTH UNIT
