EMA has released a checklist for Marketing Authorization Holders (MAHs) to use to facilitate the submission of complete and correct Type IB variations. Type IB variations are considered minor and do not require formal approval, but must be submitted to EMA 30 days prior to implementation to allow the agency to review the application and deem it acceptable. The four-page checklist notes that the submission must be in eCTD format, and includes requirements for: ● the cover letter ● the application form ● supporting documentation ● product information ● changes to the risk management plan, and ● changes to an active substance master file. The agency “strongly recommends” that the checklist be used in advance of submission of any Type IB variation.
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