199 results
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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Orphan designation: Lenvatinib for: Treatment of hepatocellular carcinoma
Date of first decision: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of papillary thyroid cancer
Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of follicular thyroid cancer
Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Submission deadlines for orphan designations (updated)
Last updated: 26/04/2021 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers (updated)
Last updated: 23/04/2021 -
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European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 (updated)
Virtual meeting, 25/03/2021, Last updated: 14/04/2021 -
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Plasma master file certificates
Last updated: 08/04/2021 -
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Change management for the EudraVigilance system
Last updated: 07/04/2021 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
Last updated: 29/03/2021 -
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Maximum residue limit opinions
Last updated: 25/03/2021 -
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COVID-19 vaccines: research and development
Last updated: 17/03/2021 -
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COVID-19 treatments: research and development
Last updated: 17/03/2021 -
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CHMP opinions on consultation procedures
Last updated: 15/03/2021 -
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Clinical Trial Regulation
Last updated: 12/03/2021 -
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International collaboration on GMP inspections
Last updated: 09/03/2021 -
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Classifications as minor-use-minor-species and limited-market
Last updated: 08/03/2021 -
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Q&A: Good clinical practice (GCP)
Last updated: 16/02/2021 -
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Changing the name or address of a sponsor
Last updated: 16/02/2021 -
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Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
Last updated: 02/02/2021 -
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PRIME: priority medicines
Last updated: 02/02/2021 -
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Big data
Last updated: 01/02/2021 -
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Immunologicals: general
Last updated: 29/01/2021 -
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ICH Q3D Elemental impurities
Last updated: 29/01/2021 -
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Fifth industry stakeholder platform on research and development support
Virtual meeting, 16/11/2020, Last updated: 21/01/2021