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The rule will make it possible to approve requests made by Invima to obtain the drugs faster, explained President Iván Duque in his daily program ‘Prevention y Acción’.
In this video, starting at minute 23:00, you can see President Duque’s announcement, which aims to mitigate the impact of COVID-19 in the country:
“This decree not only establishes clear procedures for Invima but also allows us to take an additional step after signing the purchase contracts for 40 million doses of vaccines, so that we have the process according to the schedule,” said Iván Duque.
The Minister of Health, Fernando Ruiz, then said that it was not a question of “an approval lightly” because the idea is “to speed up approval processes, that the data of the studies are presented in a timely manner, ensure that patients are informed and have a strict traceability of the products during the chain of production and distribution of medicines ”.
For their part, for the vaccine developers, it will be mandatory to present a Risk Management and Pharmacovigilance Plan for Invima to carry out rigorous monitoring.
The vaccines covered under this decree will have one year to be supplied with a single renewal opportunity; Likewise, patients will receive all the information about the medicine they receive and your signed consent will be recorded in the medical records.
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