What happened
EMA updated its GMP/GDP Q&A on 21 October 2026 concerning batch numbers on medicinal products relabelled or repacked for parallel trade. The Q&A states that applicable national legislation or guidance should be followed. Where none exists, the outer packaging should carry one batch number allocated by the parallel trader, ideally combining the original batch number with a unique repackaging or relabelling code. Traceability between original and additional numbers must be documented. If separate numbers are used, both must appear in recall information. A completely different parallel-trader batch number is strongly discouraged and requires justification and supervisory-authority authorisation.
Why it matters
From a GMP manufacturing perspective, the update highlights the importance of clear batch identification and documented links between original and repackaged products. These controls may support effective traceability and reduce confusion during recalls, including at patient level. For human medicines, the source also states that the parallel trader’s unique identifier should reflect the described batch number and that links between original and parallel-trader batch numbers should be maintained in the EU repositories system.
Key topics: Batch numbers for parallel-traded medicinal products, Traceability of repackaging and relabelling runs, Recall identification and EU repositories linkage
Source: European Medicines Agency (EMA)