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Traceability of active substances and intermediates
Entities involved in repackaging or relabelling of active substances and intermediates thereof shall ensure complete traceability of the active substances and intermediates by keeping records in accordance with Article 13(3) of Implementing Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting material in veterinary medicinal products.
Quality management
1. Repackaging, relabelling and holding of active substances and intermediates thereof shall be performed under appropriate good manufacturing controls, to avoid mix-ups and loss of active substance or intermediate identity or purity. 2. Repackaging shall be conducted under appropriate environmental conditions to avoid contamination and cross-contamination.
Stability studies
Whenever the active substance or intermediate is repackaged in a different type of container than that used originally by the active substance or intermediate manufacturer, stability studies shall be performed to justify assigned expiration or retest dates.
Transfer of information
Entities involved in repackaging or relabelling shall: (a) transfer relevant information to their customers and competent authorities in accordance with the provisions of Article 19 of Implementing Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting material in veterinary medicinal products; (b) ensure compliance with Article 47 with regards to the certificates of analysis.
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