Unique Drug Identifier required for new sanitary registrations
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 record.
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 required.
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 button.