№ lp_1_2_45103
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Character count: 36047
File size: 301 KB
Structured template and instructions for evaluating and updating PSURs submitted by MAHs within the EU regulatory framework, detailing responsibilities, steps, and data handling requirements.
Year:
2015
Type of document:
Assessment report template
Subject:
Pharmacovigilance, Periodic Safety Update Reports (PSUR)
Organization:
European Medicines Agency (EMA)
Target audience:
Lead Member States, MAHs, PRAC members
Procedure number:
Not specified
Data lock point:
Not specified
Status:
Guidance and procedural template
References:
GVP Module V, VII, VIII; Variations Classification guideline Commission Regulation 1234/2008; HMA/EMEA recommendations EMEA/743133/2009
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Date:
14 October 2016
Document type:
Stakeholder comments
Subject:
Good pharmacovigilance practices
Guideline reference:
GVP Module VI (Rev 2)
Regulatory framework:
European Union pharmacovigilance legislation
Organisation:
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Author:
Sini Eskola
Recipient institution:
European Medicines Agency
Related standards:
ICH E2B (R2), ICH E2B (R3)
Key topics:
Individual Case Safety Reports, adverse reaction reporting, EudraVigilance, validation rules, terminology consistency
Position of author:
Industry stakeholder
Public disclosure status:
Intended for publication by the Agency
Year:
2022
Region / city:
EU
Theme:
Pharmacovigilance
Document type:
Report
Organization:
European Medicines Agency (EMA)
Author:
PRAC
Target audience:
Healthcare professionals, regulatory authorities
Period of validity:
N/A
Date of approval:
DD Month YYYY
Date of modifications:
N/A
Contextual description:
Report providing detailed information on signal assessment and recommendations related to pharmacovigilance procedures for a specific safety signal in the EU.
Year:
2026
Region / city:
European Union
Subject:
Pharmacovigilance
Document Type:
Final Study Report
Organization / Institution:
European Medicines Agency (EMA)
Author:
PRAC Rapporteur
Target Audience:
EMA committee members, Marketing Authorisation Holders (MAH)
Period of Validity:
Until completion of procedure
Date of Approval:
2026-02-24
Date of Changes:
None
Year:
2011
Region / City:
Madagascar
Topic:
Health, Pharmacovigilance
Document Type:
Policy
Organization:
Ministry of Public Health, Madagascar
Author:
Ministry of Public Health
Target Audience:
Health professionals, stakeholders in health development
Effective Period:
Not specified
Approval Date:
October 2011
Amendment Date:
Not specified
Year:
2014
Organization:
EFPIA
Author:
Sini Eskola
Recipient:
European Medicines Agency (EMA)
Document type:
Comment submission
Subject:
Public hearings procedures at PRAC
Regulation reference:
Regulation 726/2004, Directive 2001/83/EC
Intended audience:
EMA, stakeholders in pharmacovigilance
Date submitted:
15 October 2014
Format:
Word document
Mode of submission:
Electronic
Stakeholder number:
Not assigned
Year:
2025
Region / city:
European Union
Topic:
Pharmacovigilance, PSUR Follow-Up
Document Type:
Report
Organ / institution:
CMDh
Author:
Lead Member State
Target Audience:
Health authorities, pharmaceutical companies, regulatory bodies
Period of validity:
February 2025 onwards
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Contextual description:
A regulatory submission form for post-marketing safety updates on human medicines, including details of the product, safety variations, and exposure data for Switzerland and worldwide.
Year:
2022
Note:
Region / City
Theme:
Post-market surveillance, safety reporting
Document Type:
Template
Author:
MDCG
Target Audience:
Manufacturers of medical devices
Year:
2016
Note:
Region / city
Subject:
Post-audit functionality, Notifications, API
Document Type:
Release Notes
Organization:
EMA
Target Audience:
NCA users, MAHs, EMA
Date of Changes:
06 Jan 16
Year:
2026
Organization:
European Medicines Agency (EMA)
Document Type:
Account Request Form
Target Audience:
NCA Staff
Purpose:
Request access to PSUR Repository
Data Protection Compliance:
Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EC) No 45/2001
Contact Email:
[email protected]
Instructions:
Fill personal and work information, specify account use and user type, agree to ECD policy
Note:
Year
Region / city:
Amsterdam
Type of document:
Assessment report
Committee / organization:
Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC)
Procedure number:
EMEA/H/C/
Rapporteurs:
CHMP Rapporteur, PRAC Rapporteur
Product type:
Generic/hybrid medicinal product
Confidential information included:
Yes / No
Year:
2022
Region / city:
EU
Theme:
Pharmacovigilance
Document type:
Report
Organization:
European Medicines Agency (EMA)
Author:
PRAC
Target audience:
Healthcare professionals, regulatory authorities
Period of validity:
N/A
Date of approval:
DD Month YYYY
Date of modifications:
N/A
Contextual description:
Report providing detailed information on signal assessment and recommendations related to pharmacovigilance procedures for a specific safety signal in the EU.
Year:
2026
Region / city:
European Union
Subject:
Pharmacovigilance
Document Type:
Final Study Report
Organization / Institution:
European Medicines Agency (EMA)
Author:
PRAC Rapporteur
Target Audience:
EMA committee members, Marketing Authorisation Holders (MAH)
Period of Validity:
Until completion of procedure
Date of Approval:
2026-02-24
Date of Changes:
None
Year:
2025
Region / City:
New Mexico
Topic:
Energy Rate Design
Document Type:
Meeting Notes
Organization / Institution:
PNM
Author:
Not specified
Target Audience:
PNM staff, stakeholders, and energy industry professionals
Effective Date:
August 2025
Date of Approval:
Not specified
Date of Changes:
Not specified
Year:
2025
Date of meeting:
April 22, 2025
Time:
2:00 p.m.
Location:
GMSC Boardroom, 1773 Water Street (lower level, accessible from Loggie Drive), Miramichi
Region / City:
Miramichi, New Brunswick, Canada
Organization:
Greater Miramichi Service Commission
Committee:
Planning Review and Adjustment Committee (PRAC)
Document type:
Meeting agenda
Meeting number:
2025-1
Agenda items:
Approval of agenda; Approval of minutes (Meetings 2024-9 and 2024-10); Selection of Chairperson and Vice-Chairperson; Declaration of conflict of interest; Review of tentative subdivision plan
Applicant:
Randy Waye, T.G. Williston Surveys Ltd.
Staff presenter:
Julien Robichaud, Development Officer
Project:
RAS CAN–IND Ltd. Subdivision — Plan 2025-1
Area concerned:
St. Margarets, Parish of Glenelg
Legal reference:
New Brunswick Regulation 80-159 under the Community Planning Act (c.19)
Purpose:
Committee review and advice regarding proposed future access related to a subdivision plan
Remote access:
MS Teams meeting link with Meeting ID and passcode
Year:
2014
Organization:
EFPIA
Author:
Sini Eskola
Recipient:
European Medicines Agency (EMA)
Document type:
Comment submission
Subject:
Public hearings procedures at PRAC
Regulation reference:
Regulation 726/2004, Directive 2001/83/EC
Intended audience:
EMA, stakeholders in pharmacovigilance
Date submitted:
15 October 2014
Format:
Word document
Mode of submission:
Electronic
Stakeholder number:
Not assigned
Date:
Thursday, September 18, 2025
Year:
2025
Region / City:
United States
Topic:
Passenger Rail, Liability, Insurance
Document Type:
Meeting Minutes
Organization:
Surface Transportation Board (STB)
Authors:
Brian O’Boyle, Henry Posner, Jim Derwinski, Lori Winfree, etc.
Target Audience:
PRAC members, STB staff, industry stakeholders
Period of Action:
September 18, 2025
Date of Approval:
N/A
Date of Amendments:
N/A
Year:
2023
Region / city:
Not specified
Topic:
Psychiatry / Case Presentation
Document Type:
Assignment Instructions
Author:
Not specified
Target audience:
Medical/Clinical students
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Context description:
Assignment instructions for creating a focused SOAP note and developing a patient case presentation, with an emphasis on psychiatric assessment and treatment planning.