ema qr code guidelines

Patients and healthcare professionals can benefit from QR Codes on packaging of medicinal products.

This fact has been acknowledged by the European Medicines Agency (EMA), which recently issued guidelines to pharmaceutical companies who wish to add a QR Code on to packaging or package leaflet of centrally authorised medicinal products.

Top 8 Highlights from the EMA Guidelines

Given below are the top 8 highlights from the guidelines:

1. Pharma companies can add a QR Code to the packaging material or package leaflet of centrally authorised medicinal products as long as the linked information is useful to the patient and not promotional in any way.

2. Pharma companies should inform the EMA of their intention to use QR Codes via a request, which can be made as part of the initial marketing authorisation application (pre-authorisation) or after the medicinal product is authorised.

3. A completed request/declaration form needs to be submitted to the EMA along with relevant information such as linked content, labelling mock-ups, and location of the QR Code.

4. The QR Code can contain any information that is relevant to the patient and the product, and can be in the form of a website, webpage, PDF document, video, or link to a mobile app. The information in the QR Code cannot be promotional.

5. The information linked with the QR Code should be ‘additional’ information to patients and health care professionals and should not replace important statutory information such as the printed package leaflet.

6. The location of the QR Code should not affect the readability of statutory information. Inclusion of several QR Codes on a single package in not recommended.

7. The QR Code should be made available in all the Member States where the medicinal product is marketed and the information should be available in all the EU official languages of those Member States.

8. Patients should have the option of either scanning a QR Code via a smartphone or entering a customised short URL in a web browser.

To read the guidelines in detail, see this document released by EMA on July 22, 2015.

How to get started?

To get started, you will need a QR Code Management tool to generate and manage the QR Codes for packaging or package leaflet of medicinal products.

A professional QR Code Management tool such as Scanova can help you:

  • Integrate QR Code generation with your labelling design software to dynamically generate QR Code with varying content
  • Generate short URLs for each URL and programmatically display the URL below the QR Code
  • Generate highly scannable QR Codes which will be scannable even if there is somewhat wear and tear of the label/packaging
  • Track QR Code scanning activity to assess the engagement levels of patients with product packaging or information provided
  • Create custom designed QR Codes that are attractive and differentiated from standard barcodes

Get started with a free trial account.


Gautam Garg is a Co-founder and the CEO of Scanova. He is a QR Code enthusiast and a big fan of inbound marketing, CRO, and usability. When taking a break, he likes to go trekking and eat spicy food.


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