News

Medicines for human use

A new version (10DEC2024) of the document ‘New Organisation First User EU QPPV/RP or Change of EU QPPV/RP’ has been published.

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February 10, 2025

Medicines for human use

A new training module EV EV-M8- Considerations on the international transfer of personal health data in ICSRs-SUSARs originating in the EU has been published

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February 10, 2025

Medicinal products for veterinary use

A new version (Rev.5) of the ‘Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points’

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February 10, 2025

Medical devices

A new version (Nov 2024) of the Q&A document on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR has been published.

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January 15, 2025

Medical devices

The Medical Device Coordination Group has published the revision 2 of the Q&A document of vigilance terms and concepts as outlined in the R 2017/745 and R 2017/746

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January 15, 2025

Medicines for human use

CMDh has published a new revision (Rev.7) of the ‘CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs

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January 14, 2025

Medicines for human use

EMA has published a new version of the List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

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January 14, 2025

Medicines for human use

EMA has published Product Management Service (PMS)-Frequently asked questions (v. 18 December 2024)

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January 14, 2025

Medicines for human use

EMA has published version 2.2 of chapter 2 from ‘PMS-Implementation of ISO standards for the IDMP in Europe’: ‘Data elements for the electronic submission of information on medicinal products for human use)

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January 14, 2025

Medicines for human use

The EMA has published version 1.4 of the ‘Extended Eudravigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials

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January 14, 2025

Medicines for human use

The EMA has published version 1.9 of Chapter 2 (‘Format for the electronic submission of veterinary medicinal product information’) of the Implementation Guide (Vet EU IG) for data on veterinary medicinal products in the EU Product Database

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January 14, 2025

Medicines for human use

The EMA has published a new update (v. 138) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’.

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June 6, 2024

NEWS

A new version (10DEC2024) of the document ‘New Organisation First User EU QPPV/RP or Change of EU QPPV/RP’ has been published.

A new training module EV EV-M8- Considerations on the international transfer of personal health data in ICSRs-SUSARs originating in the EU has been published

A new version (Rev.5) of the ‘Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points’

A new version (Nov 2024) of the Q&A document on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR has been published.

The Medical Device Coordination Group has published the revision 2 of the Q&A document of vigilance terms and concepts as outlined in the R 2017/745 and R 2017/746

CMDh has published a new revision (Rev.7) of the ‘CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs

EMA has published a new version of the List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

EMA has published Product Management Service (PMS)-Frequently asked questions (v. 18 December 2024)

EMA has published version 2.2 of chapter 2 from ‘PMS-Implementation of ISO standards for the IDMP in Europe’: ‘Data elements for the electronic submission of information on medicinal products for human use)

The EMA has published version 1.4 of the ‘Extended Eudravigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials

The EMA has published version 1.9 of Chapter 2 (‘Format for the electronic submission of veterinary medicinal product information’) of the Implementation Guide (Vet EU IG) for data on veterinary medicinal products in the EU Product Database

The EMA has published a new update (v. 138) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’.

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