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Product Regulation & Liability

Spain: Green light to the use of QR codes in promotional materials aimed at healthcare professionals

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In brief

The Ministry of Health has issued a note in which it promotes the use of QR codes to show the technical data sheet of medicinal products in promotional materials aimed at healthcare professionals. However, some information must remain in physical format to comply with the regulations on the advertising of medicinal products.

In more detail

The Directorate General for the Common Portfolio of Services of the National Health System and Pharmacy (“Directorate General”), which is part of the Ministry of Health, has recently issued an informative note with a favorable opinion on the use of QR codes to provide information on the technical data sheet of medicinal products in the promotional materials aimed at healthcare professionals.

In this regard, the Directorate General understands that the medicinal products advertising regulations published in 1994 did not contemplate the use of QR codes because they did not yet exist, but since the Covid pandemic, their use has considerably increased. Furthermore, the Directorate General also understands that technological advances are useful in providing information on medicinal products for both patients and professionals. Some of the advantages of QR codes are:

  • Improved access to information to make it more easily readable.
  • Reduction of unnecessary paper consumption.
  • Assurance of up-to-date information accessibility, which must be the information published by the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).

In addition, Autocontrol, the body in charge of advertising self-regulation in Spain, has also taken a favorable position on the use of QR codes to access the technical data sheet of medicinal products. Accordingly, the Directorate General has given the green light to the use of QR codes in advertising to healthcare professionals as long as the following guidelines, related to the regulations on advertising of medicinal products for human use, are met:

  • The QR code may be used to include the medicinal product’s technical data sheet in full or at least:
    • The name of the medicinal product.
    • The qualitative and quantitative composition of the medicinal product.
    • The related full clinical data and incompatibilities of the medicinal product.
    • The instructions for the use and treatment of the medicinal product.
    • The name and address of the marketing authorization holder of the medicinal product.
  • The QR code has to be forwarded to the most recent version of the technical data sheet, as listed in the AEMPS online medicinal products information center (CIMA). In addition, next to the QR, it should be indicated that the latter refers to the datasheet for the medicinal product.
  • Despite the above, there is some information that needs to be included in the advertising materials themselves, such as:
    • The prescription and dispensing regimens of the medicinal product.
    • The different presentations of the medicinal product, if applicable, and the dosage and its pharmaceutical form.
    • The retail price of the medicinal product, the conditions of the pharmaceutical provision of the National Health System, and, where applicable, the estimated cost of its treatment.

For more information, please click on this link to read the full note of the Directorate General. In case you need individual advice for your company, please contact our team of experts.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Damià Triay is an Associate in Baker McKenzie, Barcelona office.

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