Very recently, in July, Version 15 was released, shortly after the document was updated in May 2019 (we reported).
New in version 16 are the following questions:
- Q&A 2.23 which explains the requirements for the characters used in batch and serial numbers.
- Q&A 7.20 clarifies what is meant by "investigation" of all potential incidents of falsification in Article 37(d) of Commission Delegated Regulation (EU) 2016/161.
Additions were made to the following questions:
- Q&A 2.3 addresses the fact that barcodes on packaging should not be in proximity to each other in order to avoid errors in scanning by the end-user.
- Q&A 2.12 clarifies that a QR code with safety features should also not be placed in proximity of a data matrix.
- Q&A 4.5 states that when uploading to the repository system, manufacturers and marketing authorisation holders should work together to ensure the consistency and correctness of the information encoded in the unique identifier.
- Q&A 7.17 outlines that the NMVO should ensure that the national competent authorities, the EMA and the EU Commission are informed of falsifications. Two footnotes therefore refer to the e-mail addresses of the EMA and the European Commission.
European Commission: Safety features for medicinal products for human use