On October 25, INVIMA issued Circular DG-1000-0012-2023, which replaces Circular DG1000-040-2018 on risk management of potential shortages of medicinal products.
The circular specifies certain cases in which preventive measures must be taken to avoid shortages, including the prioritization of certain regulatory procedures. These are:
Marketing authorization for products included in the official list of vital and unavailable medicines.
Medicines officially declared to be “in short supply or at risk of shortage”.
Strategic products for public health.
Amendments to one or more marketing authorizations that may be necessary to prevent or reduce the risk of a shortage of medicinal products.
Applicants with procedures falling under some of the above cases may request that these pending procedures be assessed according to the provisions of the new Circular.
It is not clear whether procedures prioritized under the previous circular (Circular 40), but falling outside the specified cases, will retain their prioritization.
In principle, this is a preventive measure that arose because of the drug shortage alerts that were issued in the country at the beginning of October. It is still pending for INVIMA to define how it will be applied.
Original source in Spanish.
