Through Decree 1474 of September 8, 2023, in Colombia, the Ministry of Health established the following: From now on, the validity of the records will be indefinite.

Article 5. Modify Article 5° of Decree 2086 of 2010, which will be as follows: “Of the issuance and validity of the sanitary registration of medicines. The validity of the sanitary registrations of medicines will be indefinite. The sanitary registrations issued by invima or the delegated authority will be made through an administrative act, against which the resources will proceed in the terms and conditions established in the Administrative Procedure Code and the Contentious Administrative Code – CACA. The granting of indefinite validity does not prevent invima or the corresponding authority, in the exercise of inspection, surveillance and control functions, from adopting the necessary measures when finding a non-compliance with the technical norms that regulate the matter or identifying that there is a sanitary risk associated with pharmacovigilance during the use of the medicine. For those medicines that at the date of issuance of this decree already have a valid registration, their duration will become indefinite, as long as they maintain the conditions previously approved in the valid registration. The modification requests that are part of the renewal procedures in progress at the date of entry into force of this decree will be treated in the terms of Decree 334 of 2022.

Therefore, and from the entry into force of this standard, that is, on September 8th of this year, valid sanitary registrations for medicines become indefinite. For now there are no particular instructions regarding renewal requests in process and that were filed under Decree 677 of 1995. We will keep you informed about the interpretation of the health agency, as well as about any measures it may implement.

OLGA LUCIA TORRES

Country Manager Colombia

ARUNA ASESORES SAS