16 March 2022
It was only in June this year when the European Commission published Version 7.0 of their question and answer catalogue on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161. The follow-up version 8.0 was published on November 22, 2017, already. It includes 72 questions and answers in ten chapters, meaning that it has once more been expanded by important questions and an additional chapter.
The changes compared to the previous version 7.0 are as follows:
Amongst others, there are new detailed explanations on the requirements parallel importers have to meet as well as answers to the question what exactly is meant by release for sale and distribution, also considering the last putting into circulation of drug products without safety features.
Finally, known positions regarding the (non-) applicability of requirements to radiopharmaceuticals and vaccines are explicitly addressed, as well.
Overall, the complexity of the policy is revealed as well as the challenges of practical implementation and the need for answers to specific questions.
Version 8.0 of the Q&A for EU FMD DR regarding serialisation can be viewed here.