№ lp_1_2_45085
File format: docx
Character count: 36493
File size: 90 KB
Regulatory source text outlining the structure and content requirements for joint CHMP and PRAC assessment reports for informed consent marketing authorisation applications based on an existing authorised medicinal product.
Place of preparation:
Amsterdam
Regulatory framework:
Directive 2001/83/EC
Article:
Article 10(c)
Committee:
Committee for Medicinal Products for Human Use (CHMP)
Associated committee:
Pharmacovigilance Risk Assessment Committee (PRAC)
Document type:
Regulatory assessment report template
Application type:
Informed consent marketing authorisation application
Scope:
Medicinal products for human use
Responsible authority:
European Medicines Agency
Assessment procedure:
Joint CHMP and PRAC assessment
Peer review:
Not foreseen
Applicable dossier modules:
Module 1 with references to Modules 2–5
Related process:
Marketing Authorisation Application
Communication channel:
Eudralink
Intended users:
CHMP and PRAC Rapporteurs, National Competent Authorities
Document structure:
Administrative, scientific, clinical, and pharmacovigilance sections
Template status:
Draft with guidance notes
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / city:
Australia
Subject:
Airworthiness directive
Document type:
Regulatory directive
Issuing authority:
Civil Aviation Safety Authority (CASA)
Author:
David Punshon
Target audience:
Aviation maintenance personnel, aircraft operators
Effective date:
01 June 2025
Amendments:
Amendment 6
Compliance time:
12 calendar months for Requirement 1, 100 hours TIS or 12 months for Requirement 2, 20 years TIS for Requirement 3
Background:
Initial issue date: 1 February 1996
Year:
2021
Region / City:
European Union
Topic:
Cross-border marketing of EU AIFs
Document type:
Notification letter
Author:
European Commission
Target audience:
AIFMs, regulatory bodies, financial institutions
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2025
Region / City:
Oregon
Topic:
Health Care, Advance Directives
Document Type:
Legal Form
Author:
Oregon Health Authority
Target Audience:
Residents of Oregon, those preparing Advance Directives
Period of Validity:
Not specified
Date of Approval:
Not specified
Date of Changes:
July 15, 2025
Year:
2017
Note:
Region / City
Subject:
Civil Aviation Safety
Document Type:
Compliance Statement
Year:
2026
Region / City:
United States
Topic:
Data Validation, Eligibility Documentation
Document Type:
Directive
Agency / Institution:
State Government
Author:
Unknown
Target Audience:
State agencies, program administrators, and relevant stakeholders
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2016
Region / city:
Victoria, Australia
Topic:
Advance care directive, medical treatment, personal health
Document type:
Instructional guide
Organization:
Health.vic
Author:
Unknown
Target audience:
Adults creating an advance care directive
Validity period:
Indefinite
Approval date:
Unknown
Amendment date:
Unknown
Document title:
QD83 – Global Supplier Quality Directive
Edition:
2018
Document type:
Supplier acknowledgement and acceptance form
Issuing organization:
ZF Friedrichshafen AG
Applicable standard:
QD83
Related documents:
QD83-2018 Sanctioned Interpretations
Scope of applicability:
All current and future supplies to ZF Friedrichshafen AG and affiliated companies within the ZF Group
Target audience:
Suppliers of ZF Friedrichshafen AG
Legal reference:
German Stock Law §§ 15
Replacement clause:
Replaces all previous agreements on ZF Supplier Quality Directives
Exclusions:
Specific quality assurance agreements remain unaffected
Geographic scope:
Global
Language:
English
Year:
2016
Region / City:
European Union
Theme:
Financial Regulation, Supervisory Reporting
Document Type:
Instructional Guide
Organization / Institution:
European Union
Author:
European Commission
Target Audience:
Third-Country Branches, Financial Institutions, Regulatory Authorities
Period of Validity:
Ongoing
Date of Approval:
Not specified
Date of Modifications:
Not specified
Document type:
Supervisory reporting instructions
Legal basis:
Directive 2013/36/EU, Article 48k(1)
Jurisdiction:
European Union
Scope:
Financial and regulatory reporting by third-country branches
Applicable entities:
Third-country branches (Class 1 and Class 2)
Reporting framework:
Implementing Regulation XXXX (ITS on TCBs reporting)
Templates covered:
E 01.01, E 01.02, E 02.00, E 03.01, E 03.02, E 04.01, E 04.02, E 05.01, E 05.02, E 06.01, E 06.02, E 07.01, E 07.02, E 08.01, E 08.02, E 09.01, E 09.02, E 10.00
Accounting standards:
IFRS as adopted under Regulation (EC) No 1606/2002 or applicable national GAAP
Subject matter:
Assets and liabilities, off-balance sheet items, internal transactions, capital endowment, liquidity coverage, and deposit protection arrangements
Source type:
Regulatory guidance document
Year:
2025
Region / City:
Malaysia
Topic:
Export control regulations for advanced AI chips
Document type:
Guideline
Organization:
Strategic Trade Secretariat, Ministry of Investment, Trade and Industry (MITI)
Author:
Strategic Trade Secretariat
Target Audience:
Exporters, manufacturers, regulatory bodies
Effective Period:
Ongoing from 2025
Approval Date:
2025
Amendment Date:
N/A
Year:
2025
Region / City:
KwaZulu-Natal
Topic:
Court Online System Implementation
Document Type:
Draft Directive
Institution:
KwaZulu-Natal Division of the High Court
Author:
Office of the Chief Justice
Target Audience:
Legal practitioners, litigants
Period of validity:
From 1 April 2025
Approval Date:
Not specified
Date of amendments:
Not specified
Note:
Year
PART 1:
Information on the AIFM or internally managed AIF
PART 2:
Information on the AIFs to be marketed in the host Member State
Document type:
Regulatory guidance
Regulatory framework:
Directive 2001/20/EC; Regulation (EU) No 536/2014
Subject:
Transition of clinical trials from CTD to CTR
Applicable documents:
Protocol; Investigator’s Brochure; Investigational Medicinal Product Dossier
Regulatory authorities involved:
National Competent Authorities; Ethics Committees
Geographical scope:
European Union Member States
Related systems:
CTIS; EudraCT
Intended user:
Sponsor of multinational clinical trials
Referenced guidance:
EudraLex Volume 10; CTCG Best Practice Guide; European Commission Q&A
Document status:
Informational requirements for transition applications
Scope of changes addressed:
Non-substantial changes; harmonised and consolidated documents; auxiliary medicinal products; IMPD-Q submissions
Year:
2023
Region / City:
European Union
Topic:
Clinical Trials, Medical Regulation
Document Type:
Cover Letter
Organization:
European Commission
Author:
European Commission
Target Audience:
Pharmaceutical Companies, Clinical Trial Sponsors
Action Period:
Transition of Clinical Trials from Directive 2001/20/EC to Regulation (EU) No 536/2014
Approval Date:
N/A
Amendment Date:
N/A
Date:
20 September 2023
Note:
Region / City
Theme:
Drinking Water, Water Quality
Document Type:
Guidance Document
Agency / Institution:
European Commission, Directorate-General for Environment
Target Audience:
Member States, European Commission, European Environment Agency (EEA)