News - Page 12 of 17 - OC Vigilance

NEWS

Medicinal products for veterinary use

A new version (1.10) of the document ‘Format for the electronic submission of veterinary medicinal products in EEA’ has been published.

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March 4, 2025

Medical devices

A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 145)

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February 28, 2025

Medical devices

MDCG has published an update of the document ‘Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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February 11, 2025

Medicinal products for veterinary use

EMA has published a new update (v 1.7.2443-15) of the ‘Union Product Database (UPD) release notes’

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February 11, 2025

Medicines for human use

EMA has published a Guideline on specific adverse reaction follow-up questionnaries (Specific AR FUQ)

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February 11, 2025

Medicines for human use

EMA has published an update of the ‘Product Management Service’ roadmap

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February 11, 2025

Medicines for human use

EMA has published version 2.1 of the document ‘Practical guidance on the applicable rules to centrally authorised medicinal products for human use intended to be placed on the market in Northern Ireland before and after the application of Regulation (EU) 2023/1182’

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February 11, 2025

Medicines for human use

EMA has published a new version (Rev 4) of the document ‘Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level – Human medicines requirements’

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February 10, 2025

Medicines for human use

Three new updates of Detailed guidance on the electronic submission of information on medicinal product for human use have been published: Chapter 3.II (v 3.18), Chapter 5 (v. 3.5), Q&A document (v 1.13) and version 4 of the excelsheet on the XEVMP-Authorisation status

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February 10, 2025

Medicines for human use

A new versión (10 Dec 2024) of ‘Eudravigilance human-sponsor registration form’ has been published

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February 10, 2025

Medicines for human use

A new version (1.9) of ‘EudraVigilance- EVWEB User Manual’ has been published

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February 10, 2025

Medicines for human use

A new version (10DEC2024) of the document ‘EudraVigilance registration documents’ has been published

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February 10, 2025