Version 16 of the Questions & Answers (Q&As) regarding SAFETY FEATURES for MEDICINAL PRODUCTS FOR HUMAN USE has been published on 25 September 2019. The version supersedes version 15.
Changes compared to the superseded version 15 are:
addition of the new Q&As 2.23, 7.20, and
revision of the Q&As 2.3, 2.12, 4.5, 7.17.
2.23. Are there specific requirements for the characters used in batch and serial numbers? In order to reduce the risk of false alerts due to end-user scanner misconfigurations, serial and batch numbers should preferably: - Contain only uppercase letters; - Not include special characters (e.g. hyphens, question marks); and - Avoid the use of the letters "I", "O", "Y" and "Z".
7.20. What is meant by investigation of all potential incidents of falsification flagged in the system in Article 37(d) of Commission Delegated Regulation (EU) 2016/161? The purpose of the investigation is to rule out that alerts triggered in the system have been caused for technical reasons, such as - issues with the repository system, - data upload, - data quality, - incorrect end-user scanning, or - other similar technical issues. National competent authorities, the EMA and the European Commission should be informed as soon as it is clear that alert cannot be explained by technical reasons. An investigation into the falsification incident will then be launched by the authorities in line with European and national procedures.
2.3. Is it possible to keep one-dimensional barcodes on the packaging of medicinal products for human use having to bear the safety features, when adding the two-dimensional barcode carrying the unique identifier (UI)? Yes, provided that the presence of both barcodes does not negatively impact the legibility of the outer packaging. In order to avoid incorrect scanning by end-users the barcodes should not be placed in proximity to each other.
2.12. Is it allowed to place a QR code on the packaging of a medicinal product bearing the safety features? The Delegated Regulation does not prohibit the placing of a QR code as far as it is not used for the purposes of identification and authentication of medicinal products. Marketing authorization holders (MAHs) are however encouraged to exploit the residual storage capacity of the Data Matrix to include the information they would otherwise include in the QR code. This would minimize the number of codes on the packaging and reduce the risk of confusion as regard the code to be scanned for verifying the authenticity of the medicinal product. Furthermore, in order to avoid incorrect scanning by end-users, the QR code should not be placed in proximity of the Data Matrix.
4.5. Are manufacturers responsible for ensuring UIs are readable and complete? Manufacturers must check that the 2D Code is readable and contains the correct information. Furthermore, manufacturers must work closely with MAHs to ensure that all relevant information on UIs has been uploaded correctly to the repository system and corresponds to the information encoded in the UI before they release medicines for sale or distribution.
7.17. Does Article 37(d) require that a national medicine verification organization (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there a time limit for such alerting? The use of the term "provide for" in Article 37(d) of the Delegated Regulation means that an NMVO has to ensure that the national competent authorities, the EMA and the Commission are informed. The NMVO can fulfil this obligation either directly or by ensuring this task is performed by someone else. The NMVO should ensure authorities are informed as soon as it is clear that the alert cannot be explained by the technical issues mentioned under Q&A 7.20.