The QR (quick response) code is a two-dimensional barcode. The QR code can be used to present a website URL. The URL is encoded and printed on the outer packaging of a medicinal product and/or in the package leaflet. Using a QR reader (application), for example on a smartphone, a scan is made of the QR code. The app translates this scan into the URL and opens the corresponding website in the device's browser. This provides access to (digital) information about a specific medicinal product.
The policy outlined below for the QR code in the Netherlands applies to all medicinal products for which a national marketing authorisation is or has been issued. This policy is consistent with the policy agreed in the CMDh for products in the mutual recognition procedure (MRP) and decentralised procedure (DCP). This policy also applies to parallel-imported medicinal products and for marketing authorisations issued via replica marketing authorisation procedures.
This policy only applies to the use of QR codes that refer to websites with information about the medicinal product in question. 2D barcodes which are used solely for internal production processes and which do not contain information about the medicinal product are not covered by this policy. The same approach will apply to technologies with the same purpose as the QR code.
Conditions for QR code use
If a QR code is printed on the packaging and/or in the package leaflet, the conditions listed in article 69 of the Medicines Act, the policy document "Labelling of pharmaceutical products" (MEB 6) and/or the policy document "Package leaflet of pharmaceutical products" (MEB 5) must be met. Among other things, this entails that the QR code, and thus the underlying information, may not contradict with the approved summary of product characteristics, must be useful for the patient and may not promote the medicinal product. The content may not contain any public advertising.
The following information may be printed below the QR code (the so-called 'positive list'):
- legal product information such as the information in the SmPC, package leaflet and labelling
- information relating to pharmacovigilance, such as educational material
The form in which the information is provided is not defined, as long as the conditions regarding the information behind the QR code are met. The information from the positive list will be made available through the QR code by the marketing authorisation holder. The marketing authorisation holder ensures the information on the website in question is kept up-to-date.
A QR code may be displayed on the packaging and in the package leaflet, on the condition that it is less prominently displayed than the legally required information that is mandatory on the packaging. For small packaging, the QR code may be applied on the inside of the packaging.
In order to make patients aware that there may be differences between the most recent approved product information and the printed package leaflet, the following sentence should be included in the package leaflet:
“Over dit geneesmiddel is gedetailleerde en geactualiseerde informatie beschikbaar door de QR-code te scannen met een QR-lezer een applicatie (app) voor smartphone of tablet. Dezelfde actuele informatie over het geneesmiddel is ook beschikbaar via de volgende URL: <…> en op de website van het College ter Beoordeling van Geneesmiddelen (www.geneesmiddeleninformatiebank.nl)”.
The complete URL referred to by the QR code is listed under the QR code, so access to the information is also available to patients unable to scan the QR code.
Displaying the QR code does not depend on the legal status of supply, and is allowed for both medicinal products only available on prescription and those available over the counter.
Procedure for including a QR code
In the application for marketing authorisation, the applicant must submit a declaration confirming that the QR code is compliant and continues to be compliant with the imposed requirements. In case of a DCP or an MRP, the declaration must be submitted on D106 at the latest. For a national procedure, the applicant must submit the declaration no later than the second round. Any later during the application procedure for marketing authorisation a declaration will no longer be accepted.
With this declaration, the applicant confirms that the content of the QR code is and shall remain in accordance with applicable regulations. If a marketing authorisation has already been issued for a medicinal product, the addition of a QR code may be submitted via an article 61(3) notification. Furthermore, the addition of a QR code may also be submitted together with another change to the product information in a type IB or type II variation of the C category or during a renewal.
For parallel-imported medicinal products, the QR code from the original supplier must be taped over.
Documentation to be submitted
The following documentation must be submitted when applying for a QR code on the packaging and/or in the package leaflet:
- Completed QR code declaration:
- For MRP/DCP procedures: Annex 2: Applicant's declaration template
- For national procedures: Application for the inclusion of QR code in national procedures
- Mock-ups of packaging and/or package leaflet (depending on where the QR code is presented) in actual size
- Package leaflet: Please note that the following text must be added:
"Over dit geneesmiddel is gedetailleerde en geactualiseerde informatie beschikbaar door de QR-code te scannen met een QR-lezer, een applicatie (app) voor smartphone of tablet. Dezelfde actuele informatie over het geneesmiddel is ook beschikbaar via de volgende URL: <...> en op de website van het College ter Beoordeling van Geneesmiddelen (www.geneesmiddeleninformatiebank.nl)"