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Document: Annex I questions and answers – Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use-2025/7/10
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Document: Annex IV questions and answers – Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices-2025/7/10
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Document: Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1-2025/7/10
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Page: Dronedarone product-specific bioequivalence guidance-2025/7/10
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Page: Ledipasvir/sofosbuvir product-specific bioequivalence guidance-2025/7/10
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Document: Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1-2025/7/10
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Document: Guide to CTIS training material catalogue-2025/7/9
2025-07-10查看详情 > -
Document: Clinical Trial Information System (CTIS) structured data form -– Notifications, Annual Safety Report (ASR) and results-2025/7/9
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Document: Minutes of the HMPC meeting 5-7 May 2025-2025/7/9
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Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)-2025/7/9
2025-07-10查看详情 >