Post licensing information for marketing authorisation holders
Renewals, transfers and withdrawals
When and how to submit applications for renewals, transfers and withdrawals
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Market compliance and surveillance
Comply with regulations for quality defects, recalls and advertising of medicines.
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Multilingual packaging
Apply to use packs with multiple languages to keep medicines avaialable in Ireland
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Product Information Update (PIU)
When to issue a communication about important changes to product information
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Batch-specific requests
Apply for a batch-specific request to ensure a medicine remains available
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Nitrosamine impurities
Submit information related to reviewing and mitigating the risk nitrosamine impurities
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Pharamacovigilance requirements
Preparing DHCPs, educational materials and submitting PASS protocols
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