The Directorate of Drugs and Biological Products of the
Colombian Ministry of Health (MoH)– now requires the
pharmaceutical drug industry to submit the corresponding Unique
Drug Identifier (IUM, according to its Spanish acronym) for all
pharmaceuticals for human use. The change is a result of Resolution
No. 3166 in force since 2015, which defined and implemented the
data standard for pharmaceuticals for human use in Colombia.
Interested parties should request the IUM for the MoH, as it
will be mandatory for issuing new sanitary registrations and for
the approval of non-available life-saving medications. According to
the provisions of the aforementioned resolution, the IUM shall be
filed as follows:
1) The IUM previously granted shall be presented to the MoH for
each commercial presentation of the dossier requested within.
2) To file the application before the National Food and Drug
Surveillance Institute (INVIMA) under the Colombian MoH, it is
required to submit the IUM in hard copy for the corresponding
3) Once the application is filed, the procedure will continue
according to current practice; and, at the time of the examination,
the correlation between the information provided to obtain the IUM
and the information filed by the interested party before the INVIMA
will be verified.
4) According to MoH's guidelines, lack of conformity will
consequently imply requiring a new IUM filing; this shall resolve
the inconsistency as well as other technical and legal aspects
5) If such sanitary registration is approved, the IUM will be
included in the resolution of this new sanitary registration.
For further information, visit the ministry website at www.minsalud.gov.co and click on the IUM
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