European Commission Q&A, version 16, on “Safety Features for Medicinal Products for Human Use”.

Version 16 of the Q&A “Safety Features for Medicinal Products for Human Use” has been released. The changes in the latest version are:

2.23 new question, covers specific requirements for characters used in serial and batch numbers.

Serial and batch numbers should preferably:

-Contain only uppercase letters;

-Not include special characters (eg. hyphens, question marks, etc.); and

-Avoid the use of the letters "I", "O", "Y" and "Z".

 

7.20 new question "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?"

In short, the purpose of the investigation in Article 37(d) is to rule out that alerts triggered in the system have been caused for technical reasons.

 

2.3 revised question, clarification regarding barcodes added:

In order to avoid incorrect scanning by end-users, if possible, the barcodes should not be placed in proximity to each other.

 

2.12 revised question, clarification regarding QR code added:

Furthermore, in order to avoid incorrect scanning by end-users, if possible, the QR code should not be placed in proximity of the Data Matrix.

 

4.5 revised question,  word correctly added for emphasis:

manufacturers must work closely with marketing authorisation holders to ensure that all relevant information on unique identifiers has been uploaded correctly to the repository system and corresponds to the information encoded in the unique identifier before they release medicines for sale or distribution

 

7.17 revised question, footnotes added

 

 

You can download the latest version here, which has the revisions highlighted for your ease.