Por: Ruth Olivares, Olga Torres.

On March 15 of this year, the new Procedure for the Entry of Health Registration and Health Registration Files to the Department of Regulation and Control of Pharmaceutical and Related Products and National Health Laboratory came into force in Guatemala.

It establishes that as of Tuesday, March 15, 2022, the user interested in entering Health Registration and Sanitary Inscription dossiers, must do it as follows:

  1. The user must manage the payment of the respective fees by means of receipt 63 A2, in the building of the Department of Regulation and Control of Pharmaceutical and Related Products, located in Zone 8 of Guatemala City.
  2. The application file must be submitted to the Documents Reception Window, for which it is necessary to attach:
    •  Application form in its current version
    •  Receipt of payment of fees 63 A2, both from the Department of Regulation and Control of Pharmaceutical and Related Products, as well as from the National Health Laboratory, in copy.
    • Necessary documents according to the procedure.
  • After that, and with the previous review of the authority, the user may submit the dossier, samples and standards (as required), to the National Health Laboratory, either at the Windows located in Zone 08 of Guatemala City or at Carretera al Pacífico, Bárcenas, Villa Nueva.

For which it will also be required the copy of the password of entrance before the Department of Regulation and Control of Pharmaceutical and Related Products.

Please note that in the case of samples or standards that require refrigeration, the dossier may only be submitted at the facilities of the National Health Laboratory, located in Bárcenas, Villa Nueva.