EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers

On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.

Medicinal products that are relabeled or repacked with the purpose of parallel trade should be in compliance with any specific national legislation or guidance in relation to the batch number(s) that are to be present on the parallel distributed traded packs.

In the absence of specific national legislation or guidance, the outer packaging should have only one batch number, as allocated by the parallel trader. This batch number allocated by the parallel trader should incorporate two components; (1) the batch number of the original pack and (2) a unique code identifying the repackaging/relabeling run. The code for the repackaging run may comprise numbers or letters or a combination of both. The parallel trader’s batch number should be such that Component 1 above (originator batch number) is followed by Component 2 (a code related to the repackaging/relabeling run on that batch). Any deviation from this approach should be presented to and should be authorized by the supervisory authority. The traceability between the original batch number and the parallel trader’s batch number should be documented in the manufacturer’s repackaging records.

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