EMA Clarifies Batch Numbering for Parallel-Traded Medicines
EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.
Unless specific national provisions apply, outer packaging should carry one batch number allocated by the parallel trader. Ideally, this combines the original batch number with a unique repackaging or relabelling run code.
Where a different numbering approach is used, the link must be documented in repackaging records, and recall information must identify both numbers. A sole batch number entirely different from the original is permitted only in justified cases authorised by the supervisory authority.
For human medicines, the unique identifier generated when placing or replacing safety features should reflect the corresponding batch number. The link to the original batch number should be maintained in the EU repositories system.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
