Authorization of the use of QR in promotionals material for healthcare professionals
The General Directorate for the Common Portfolio of Services of the National Health System (DGCCSF) has recently issued an informative note approving the use of QR codes to refer to the technical data sheet of drugs in promotional materials aimed at healthcare professionals.
Recently, AUTOCONTROL has issued a communication to its members on the feasibility of replacing the contents of the technical data sheet of medicinal products in promotional materials aimed at healthcare professionals with a QR code that allows access to the information by computerized means. Following the communication issued by AUTOCONTROL, and due to the various issues raised with the DGCCSF, the DGCCSF has issued an informative note confirming the possibility of QR codes being used to send the technical data sheet of medicines in promotional materials aimed at healthcare professionals.
The advertising of medicinal products for human use is regulated by Royal Decree 1416/1994, of June 25, 1994, and specifically, article 10 establishes the minimum content that must be included in advertising aimed at healthcare professionals: a) The essential information of the product according to the data contained in the technical data sheet, including at least: name of the medicinal product, qualitative and quantitative composition, complete clinical data, incompatibilities, instructions for use/handling, name and address of the holder of the authorization. b) Its prescription and dispensing regime. c) The different presentations of the product, if applicable, and the dosage and/or pharmaceutical form. It is also established that advertising must include the retail price, the conditions of the pharmaceutical benefit of the National Health System, if applicable, and, when possible, the estimated cost of treatment.
While it is true that the inclusion of QR codes in this type of advertising is allowed, several clarifications are necessary:
-The QR Code can be used to address only the technical data sheet, thus complying with the provisions of Article 10.1 a) of Royal Decree 1416/1994.
-It is necessary that the code that replaces the data sheet refers to the information made public by the Spanish Agency of Medicines and Health Products in CIMA. In turn, it should be indicated next to the QR Code that it will refer to the data sheet.
-The information contained in Articles 10.1 b) and 10.1 c) cannot be stored in a QR code, and must continue to be provided in promotional material.
Access to information through the use of QR codes is a reality that, following the COVID-19 pandemic, has spread significantly, and will allow healthcare professionals to access the latest updated information, and in turn, display the information in a more accessible manner.