By: Gelmis López
In compliance with Circular MS-ANRS-DF-KVDM-7941-12-22 issued by the Pharmacy Directorate attached to the National Health Regulation Authority (ANRS), makes the following known to users:
– To allow the inclusion of the QR code printed on the packaging/case/envelope/packaging/primary and/or secondary packaging of all registered presentations of pharmaceutical products, in order to allow immediate access to the information through different mobile devices.
– The incorporation of the QR code on the packaging/case/envelope/packaging/primary and/or secondary packaging of the pharmaceutical products will be optional at this initial stage. The QR code may coexist with the printed version of the insert in paper format; the QR code does not replace the drug package insert.
– The information to which the product user will have access through the QR code must be approved by the Health Authority. In case of modification and/or update of technical information, this must be previously approved by the Pharmacy Department.
– The creation, modification and/or update of the information that will be accessed through the QR code will be under the responsibility of the holder of the product registration.
– To include, modify and/or update the QR code on the packaging/case/envelope/packaging/primary and/or secondary packaging of pharmaceutical products, it must be entered in the Karplus system as a type C change.
This circular will be effective as of February 01, 2023.