The views expressed in this questions and answers document should not be considered a formal interpretation of Union law, nor are legally binding.
These FAQ’s should be read in conjunction with European Commission – Safety Features for Medicinal Products for Human Use ‘Questions and Answers’ and the MHRA Newsletters.
NB. Although these FAQs are primarily directed at pharmaceutical manufacturers it is recognised that almost all of them will also hold a WDA. Consequently, there are FAQs included that have a relevance to wholesalers including wholesaler software that may be of interest to pharmaceutical manufacturers.
Will the UK require a reimbursement code as well?
Can additional information be included in the 2D matrix)
Are we required to contract with SecurMed UK and pay fees for the UK system?
Providing an updated version of the QRD template confirming implementation of the safety features on the packaging?
The national code does not need to be embedded in the 2D data matrix, however, according to the EMVO coding requirements, it is still required to be sent to the UK Medicines Verification System.