Category: Medicines for human use

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.

T1,T2,T3

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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

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

T2,T3

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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

T2,T3

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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

T2,T3

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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’.

T2,T3

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June 6, 2024

Medicines for human use

Version 3 of Chapter 7 (‘XEVMPD and SIAMED II to PMS-Initial Migration guide’ )of the ‘PMS-Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe’ has been published.

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May 22, 2024

Medicines for human use

Version 3 of chapter 1 ‘Registration requirements’ has been published in the documentation ‘ Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe’.

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May 17, 2024

Medicines for human use

The EMA has published the document “New Organization first user EU QPPV/RP or change of EU/QPPV/RP”.

T1, T2, T3

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May 15, 2024

Category: 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.

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

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’.

Version 3 of Chapter 7 (‘XEVMPD and SIAMED II to PMS-Initial Migration guide’ )of the ‘PMS-Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe’ has been published.

Version 3 of chapter 1 ‘Registration requirements’ has been published in the documentation ‘ Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe’.

The EMA has published the document “New Organization first user EU QPPV/RP or change of EU/QPPV/RP”.

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