National implementation of additional information available through mobile scanning of QR codes and other technologies for centrally authorised medicinal products
According to the guideline published by the European Medicines Agency (EMA), "Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products”, when the content and appearance of additional information available through mobile scanning of QR codes and other technologies has been approved by CHMP (content which is not a part of product information, e.g. a video containing instructions for the administration of the medicinal product), the applicant is required to contact the national competent authority to agree on their implementation in the local language.
Before the platform hosting the additional information becomes available to patients / healthcare professionals, the Croatian translation of the approved additional information should be reviewed by HALMED.
The request for review of additional information in the Croatian language can be sent to qrd.hr@halmed.hr. The request should contain:
- The confirmation that EMA has approved the content and appearance of the webpage, including the additional information
- The suggested Croatian version of additional information available through mobile scanning of QR codes and other technologies (e.g. video transcript in Croatian)
- The approved content of additional information in English, with a link to the webpage which will host the information (if the webpage is already available)
After the request has been submitted, HALMED will check whether the information in Croatian language matches the approved information in English within a short timeframe, and either send the consent for implementation, or send comments with the corrections necessary before the implementation.
The request for review of additional information in the Croatian language should be sent to HALMED before the initial activation of the webpage hosting the additional information and after any modification of the information approved by EMA.
The applicant is responsible for the implementation of other information which will be available through the QR code, which are part of the approved product information (statutory information, e.g. sections of the Package Leaflet or Summary of Product Characteristics) and have been reviewed during QRD product information review.
