№ lp_1_2_24509
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Regulatory guidance and procedural template defining the structure, content, responsibilities, and update process for CHMP assessment reports across multiple milestones leading to final opinion and EPAR publication.
Organisation:
European Medicines Agency
Committee:
Committee for Medicinal Products for Human Use
Document type:
Assessment report template and procedural guidance
Procedure scope:
Initial marketing authorisation and EUM4All applications
Geographical scope:
European Union
Language variant:
British English
Intended contributors:
Rapporteurs, Co-Rapporteurs, PRAC Rapporteurs, EMA Procedure Assistants
Regulatory framework:
EU medicines regulatory procedure
Document status:
Living document updated across procedural milestones
Source type:
Regulatory guidance and internal procedural template
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
Amsterdam
Subject:
Request for extension of clock stop duration in the centralized marketing authorization process
Document Type:
Request template
Organization / Institution:
European Medicines Agency
Author:
EMA
Target Audience:
Marketing Authorization Holders, Applicants
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2026
Region / City:
EU
Theme:
Regulatory Affairs, Pharmaceuticals
Document Type:
Template
Organization:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Pharmaceutical companies, regulatory affairs professionals
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
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:
2019
Region / city:
Ireland
Topic:
Investment company, liquidation
Document type:
Consultation Paper
Institution:
Central Bank of Ireland
Author:
Central Bank of Ireland
Target audience:
Investment companies, financial institutions
Period of validity:
Indefinite until revocation
Date of approval:
July 2019
Date of amendments:
N/A
Purpose:
Outline of the appeal process for reviewable decisions
Jurisdiction:
South Australia
Scheme:
South Australian Restrictive Practices Authorisation scheme
Legal basis:
Disability Inclusion Act 2018 (Part 6A, ss. 23L, 23N, 23O, 23P, 23Y, 23Z)
Regulations:
Disability Inclusion (Restrictive Practices – NDIS) Regulations 2021, s. 14
Document type:
Administrative procedure
Responsible unit:
Restrictive Practices Unit
Decision-makers:
Authorised Program Officer; Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Scope:
Appeals of reviewable decisions relating to restrictive practices
Target audience:
RPU staff, people with disability, family members, NDIS service providers
Appeal timeframe:
30 days from original decision, with possible extension
Review bodies:
Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Source type:
Government administrative procedure governing appeals and reviews of restrictive practice authorisation decisions within the South Australian NDIS regulatory framework.
Note:
Year
Theme:
Special Religious Education, Child Protection
Document Type:
Authorisation Letter
Organisation / Institution:
Department of Education
Target Audience:
Approved Providers, School Coordinators
Year:
2024
Region / City:
Malta
Topic:
ICT Third-Party Service Providers
Document Type:
Regulatory Form
Organization / Institution:
Malta Financial Services Authority (MFSA)
Author:
Malta Financial Services Authority (MFSA)
Target Audience:
Financial entities applying for authorisation from MFSA
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2003
Jurisdiction:
Victoria, Australia
Document type:
Application form / Regulatory form
Regulation:
Cemeteries and Crematoria Regulations 2025, Regulation 30
Issuing authority:
Victorian Government
Related legislation:
Births, Deaths and Marriages Registration Act 1996; Coroners Act 2008; Privacy and Data Protection Act 2014; Public Records Act 1973
Purpose:
Authorisation of cremation for deceased persons
Attachments required:
Notice of death, Certificate of registered medical practitioner, Coroner’s order, notice of still-birth (if applicable)
Penalties:
False statements punishable under section 132 of the Cemeteries and Crematoria Act 2003
Applicant type:
Natural person or corporate body
Cremation details:
Name of crematorium, date of cremation, place and type of interment
Contact information:
Applicant and funeral director details, including address, telephone, and email
Year:
2003
Region / City:
Victoria, Australia
Theme:
Cemeteries and Crematoria Regulations
Document Type:
Form
Author:
Victoria State Government
Target Audience:
Individuals arranging for interment of bodily remains
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
2025
Year:
2025
Region / City:
EU
Subject:
Marketing Authorisation Variations
Document Type:
Supplementary Guidance
Organisation:
MHRA
Author:
Not specified
Target Audience:
Marketing Authorisation Holders (MAHs)
Period of Validity:
Ongoing, updates in 2025 and 2026
Date of Approval:
Not specified
Date of Changes:
December 2025
Note:
Contextual Description
Note:
Year
Contextual description:
Declaration form for the engagement of approved Special Religious Education (SRE) providers with the Department of Education, verifying compliance with child protection regulations.
Note:
Year
Context:
Form for requesting changes to a manufacturer’s authorization related to medicinal products for human and veterinary use, including variations to manufacturing operations, product types, and quality control processes.
Year:
2023
Region / city:
Not specified
Topic:
Veterinary medicine, Marketing authorisation
Document type:
Template
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Professionals in veterinary medicine and regulatory affairs
Period of validity:
Not specified
Approval date:
Not specified
Date of revision:
13/06/23
Note:
Year
Note:
Year
Year:
2021
Region / City:
Mauritius
Subject:
Training Institution Change Authorization
Document Type:
Form
Institution:
Mauritius Qualifications Authority
Target Audience:
Registered Training Institutions
Period of Validity:
Until completion of process
Approval Date:
15 October 2021
Amendment Date:
N/A
Note:
Year
Document Type:
Quality Technical Agreement
Year:
2022
Region / City:
Birmingham
Theme:
Commonwealth Games
Document Type:
Process Guidelines
Organization:
Birmingham Organising Committee for the 2022 Commonwealth Games Limited
Author:
Birmingham Organising Committee for the 2022 Commonwealth Games Limited
Target Audience:
Advertisers, traders, media owners
Period of Validity:
21 July 2022 to 10 August 2022
Approval Date:
June 2022
Date of Changes:
None