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Intellectual Property Bulletin

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COLOMBIA

PRESCRIPTION OF MEDICINES IS AUTHORIZED FOR INDICATIONS NOT INCLUDED IN THE HEALTH REGISTRATION “OFF LABEL”

On February 28th, the Colombian Ministry of Health issued Resolution no. 532 of 2017, whereby it authorized the prescription of medicines whose indication is not included in the health registration issued by INVIMA, known as prescription of off label uses.

 

The provision establishes that prescription of these drugs can be made provided that the indication of the prescribed use has been reported by the Colombian Scientific Societies to the Ministry of Health or is included in the list of “Excluded uses”, and, in both cases, the consent of the patient is required.

In the event of complications arising from the use of said medicines “off label”, the liability will be of the treating doctor, jointly with the Health Care Institution (IPS in Spanish) which authorizes its use.