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The AEMPS provides new information on the adaptation of veterinary medicinal products to QRD v9.0

Generate PDF Spanish Version Fecha de publicación: 23 de enero de 2024 Categoría: medicamentos veterinarios Referencia: MVET, 02/2024 Regulation (EU) 2019/6 sets January 29 2027 as the deadline for veterinary medicinal products (VMPs) authorized in accordance with the former legislation to be in compliance with the aforementioned regulation For this reason, it is necessary to […]

The AEMPS enables a tool to request the inclusion of additional information on the packaging of veterinary medicinal products based on article 13 of Regulation (EU) 2019/6

Generate PDF Spanish version Publication date: January 22, 2024 Categoría: medicamentos veterinarios Referencia: MVET, 01/2024 The AEMPS enables RAEVET for the submission of this information. This system makes access to this service easier for applicants and speeds up the process The AEMPS will allow such inclusion only if it is considered useful information, if it […]

Repurposing and better use of Clinical Data

Date post: September 11th, 2023 Date: 27/09/2023 On the 27th September, AEMPS is organising a multistakeholder meeting on repurposing and clinical data under the title: Repurposing and better use of Clinical Data, to promote the repurposing of medicinal products and how the better use of clinical data can help the repurposing of medicines in the […]

Shaping a European innovation ecosystem: EU-Innovation Network multi-stakeholder meeting

Date post: July 5th, 2023 Date: 26/09/2023 On the 26th September, AEMPS and the EU-Innovation Network (comprised of representatives from innovation offices within NCAs and EMA’s Innovation Task Force (ITF)) are organising a multistakeholder meeting on innovation under the title: Shaping a European innovation ecosystem: EU-Innovation Network multi-stakeholder meeting to promote research and development of […]

The AEMPS reports on the update of the payment procedure for veterinary medicinal products

Formato pdf Fecha de publicación: 28 de enero de 2022 Categoría: medicamentos veterinarios Referencia: MVET, 02/2022 On January 28, 2022, Regulation (EU) 2019/6, of December 11 2018, of the European Parliament and Council, on veterinary medicinal products and repealing Directive 2001/82/EC, entry into force The Spanish Agency of Medicines and Medical Devices, as the competent […]

Exceptional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency

Formato pdf Date of update: 1st July 2020 Category: medicinal products of human use, COVID-19 Reference: MUH 04/2020 These measures are aimed at guaranteeing the trial activity, the safety and well-being of the patient and the traceability of the actions implemented They are complementary measures to those adopted recently in the EU and include the […]

La AEMPS ha participado en 2 workshops internacionales para potenciar el desarrollo de tratamientos y vacunas contra COVID-19

Formato pdf Fecha de publicación: 16 de abril de 2020 Categoría: la AEMPS, COVID-19 Referencia: AEMPS, 14/2020 Se han celebrado dos workshops regulatorios virtuales sobre COVID19 en el marco de la Coalición Internacional de Autoridades Reguladoras de Medicamentos (ICMRA, por sus siglas en inglés). Ambos encuentros han permitido un acercamiento entre agencias reguladoras de medicamentos […]

La AEMPS ha participado en 2 workshops internacionales para potenciar el desarrollo de tratamientos y vacunas contra COVID-19

Formato pdf Fecha de publicación: 16 de abril de 2020 Categoría: la AEMPS, COVID-19 Referencia: AEMPS, 14/2020 Se han celebrado dos workshops regulatorios virtuales sobre COVID19 en el marco de la Coalición Internacional de Autoridades Reguladoras de Medicamentos (ICMRA, por sus siglas en inglés). Ambos encuentros han permitido un acercamiento entre agencias reguladoras de medicamentos […]