Letter of intent for the submission of a worksharing procedure to the European Medicines Agency according to Article 65 of Regulation (EU) 2019/6

Letter of intent for the submission of a worksharing procedure to the European Medicines Agency according to Article 65 of Regulation (EU) 2019/6

Human medicines European public assessment report (EPAR): Ogluo, glucagon, Date of authorisation: 11/02/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Ogluo, glucagon, Date of authorisation: 11/02/2021, Revision: 8, Status: Authorised

Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders

Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders

Workshop on a tailored clinical approach in biosimilar development, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 September 2025, 09:00 (CEST) to 22 September 2025, 16:00 (CEST)

Workshop on a tailored clinical approach in biosimilar development, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 September 2025, 09:00 (CEST) to 22 September 2025, 16:00 (CEST)

First European Medicines Agency (EMA) and Association of Clinical Research Organizations (ACRO) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

First European Medicines Agency (EMA) and Association of Clinical Research Organizations (ACRO) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product information

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product information

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