News about GMP/cGMP

04.10.2019

Revised Version 16 of Q&A on Safety Features for Medicinal Products for Human Use

The updates on this document are overturning: On 25 September 2019, the European Commission published Version 16 of the document on safety features for medicinal products for human use. 

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.

Source:

European Commission: Safety features for medicinal products for human use



Comments

No comment has yet been written about this news


Write your comment about this news