The measure aims to strengthen the quality, traceability, and reliability of the information used for monitoring and regulating the Colombian pharmaceutical market. Among the most relevant changes is the incorporation of data associated with electronic sales invoices, including the mandatory reporting of the Unique Electronic Invoice Code (CUFE), which will enable validation of the reported information and reduce inconsistencies in the records.
Likewise, the Circular establishes that reported quantities must be expressed exclusively in the Minimum Dispensing Unit (MDU), with the objective of standardizing information and avoiding errors related to billing units or the commercial presentation of medicines.
The new regulation also updates reporting obligations for manufacturers, importers, marketing authorization holders, distributors, and other stakeholders within the commercialization chain, establishing new reporting structures, submission deadlines, and information validation mechanisms.
As a transitional measure, the Circular provides for a three-month testing period to allow obligated parties to adapt to the new requirements, during which the current reporting scheme will remain in effect. Thereafter, the new technical annexes will enter into force and the previous provisions will be repealed.
Through this update, the authorities seek to improve the availability of strategic information for market surveillance, price regulation, and decision-making related to access to and supply of medicines in the country.
