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Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs

Submitted by Anonymous (not verified) on 8 January 2025 - 7:23

Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs

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Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide

Submitted by Anonymous (not verified) on 7 January 2025 - 16:15

Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide

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PSUSA/00003163/202403

Submitted by Anonymous (not verified) on 7 January 2025 - 16:14

PSUSA/00003163/202403

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Referral: Ocaliva, obeticholic acid Article 20 procedures European Commission final decision, 27/06/2024, 30/08/2024, 07/01/2025

Submitted by Anonymous (not verified) on 7 January 2025 - 16:00

Referral: Ocaliva, obeticholic acid Article 20 procedures European Commission final decision, 27/06/2024, 30/08/2024, 07/01/2025

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List of signals discussed at PRAC since September 2012

Submitted by Anonymous (not verified) on 7 January 2025 - 15:41

List of signals discussed at PRAC since September 2012

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New product information wording – Extracts from PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC

Submitted by Anonymous (not verified) on 7 January 2025 - 15:18

New product information wording – Extracts from PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC

Read more about New product information wording – Extracts from PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC

Pharmacovigilance Inspectors Working Group

Submitted by Anonymous (not verified) on 7 January 2025 - 15:01

Pharmacovigilance Inspectors Working Group

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PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting

Submitted by Anonymous (not verified) on 7 January 2025 - 14:59

PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting

Read more about PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting

EudraVigilance human - Sponsor registration form

Submitted by Anonymous (not verified) on 7 January 2025 - 14:18

EudraVigilance human - Sponsor registration form

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EudraVigilance - EVWEB user manual

Submitted by Anonymous (not verified) on 7 January 2025 - 14:16

EudraVigilance - EVWEB user manual

Read more about EudraVigilance - EVWEB user manual

Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs

Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide

PSUSA/00003163/202403

Referral: Ocaliva, obeticholic acid Article 20 procedures European Commission final decision, 27/06/2024, 30/08/2024, 07/01/2025

List of signals discussed at PRAC since September 2012

New product information wording – Extracts from PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC

Pharmacovigilance Inspectors Working Group

PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting

EudraVigilance human - Sponsor registration form

EudraVigilance - EVWEB user manual

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