8118 results
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Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (updated)
Last updated: 23/07/2021 -
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Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 (updated)
Last updated: 23/07/2021 -
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Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (updated)
Last updated: 23/07/2021 -
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Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets) (updated)
Last updated: 23/07/2021 -
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Manufacture of the finished dosage form (veterinary) (updated)
Last updated: 23/07/2021 -
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Notifying a change of marketing status (updated)
Last updated: 23/07/2021 -
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Pre-authorisation guidance (updated)
Last updated: 23/07/2021 -
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Environmental risk assessment of veterinary medicinal products intended to be used in aquaculture (new)
Last updated: 23/07/2021 -
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COVID-19: latest updates (updated)
Last updated: 23/07/2021 -
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Summary of product characteristics for anthelmintics (updated)
Last updated: 23/07/2021 -
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Quality documentation for medicinal products when used with a medical device (updated)
Last updated: 23/07/2021 -
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Data requirements for adjuvants in vaccines for veterinary use (updated)
Last updated: 23/07/2021 -
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Clinical trials with immunological veterinary medicinal products (new)
Last updated: 23/07/2021 -
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MRL evaluation for biological substances (new)
Last updated: 23/07/2021 -
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Data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances (updated)
Last updated: 23/07/2021 -
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Data requirements for vaccine platform technology master files (PTMF) (updated)
Last updated: 23/07/2021 -
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ePI information workshop and exploratory workshop (updated)
Virtual event, from 05/07/2021 to 08/07/2021, Last updated: 21/07/2021 -
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COVID-19 vaccines: under evaluation (updated)
Last updated: 20/07/2021 -
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COVID-19 vaccines (updated)
Last updated: 20/07/2021 -
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Info day for micro, small and medium-sized enterprises (SMEs): EMA support for SMEs under the new Veterinary Medicinal Products Regulation (new)
Virtual meeting, 28/10/2021, Last updated: 20/07/2021 -
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Herbal medicinal product: Menyanthidis trifoliatae folium (updated)
Menyanthes trifoliata L., Bogbean leaf, F: Assessment finalised, Last updated: 20/07/2021 -
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Paediatric investigation plans: questions and answers (updated)
Last updated: 19/07/2021 -
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Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 23 July 2021 (new)
Virtual meeting, 23/07/2021, Last updated: 19/07/2021 -
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COVID-19 vaccines: key facts (updated)
Last updated: 19/07/2021 -
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COVID-19 treatments (updated)
Last updated: 19/07/2021