№ lp_1_2_45077
File format: docx
Character count: 10486
File size: 42 KB
Note:
Year
Contextual description:
A checklist for the submission of variations related to type II clinical and non-clinical changes to product information in the European market.
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Year:
2026
Region / City:
International
Theme:
Research Ethics
Document Type:
Standard Operating Procedure (SOP)
Organ / Institution:
ISU-IREB
Author:
ISU-IREB SOP Team
Target Audience:
Researchers, IREB Members
Period of Validity:
Ongoing
Approval Date:
2026-02-03
Date of Changes:
N/A
Year:
2021
Region / city:
N/A
Subject area:
Toxicology
Document type:
Template
Author:
BioCelerate
Target audience:
Researchers, regulatory professionals
Period of validity:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2026
Region / city:
N/A
Subject:
Pharmaceutical regulatory submission
Document type:
Submission guidelines
Authority / institution:
N/A
Author:
N/A
Target audience:
Applicants for pharmaceutical submissions
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
N/A
Region / City:
N/A
Subject:
Toxicology Study Plan/Protocol
Document Type:
Template
Organization / Institution:
BioCelerate
Author:
N/A
Target Audience:
Researchers, Sponsors, and CROs involved in nonclinical studies
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Document Type:
Regulatory guidance
Module:
2.4 Nonclinical Overview
Framework:
Common Technical Document (CTD)
Related Guideline:
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Note:
Related Guideline
Guidance for Industry M4S: The CTD — Safety
Subject:
Nonclinical testing strategy, pharmacology, pharmacokinetics, and toxicology
Intended Application:
Registration of pharmaceuticals for human use
Referenced Standards:
Good Laboratory Practice (GLP)
Scope:
Evaluation of pharmacologic, pharmacokinetic, toxicologic, and impurity data
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
Year:
Not specified
Region / City:
Not specified
Topic:
Building code compliance, Fire safety regulations
Document type:
Template
Agency / Organization:
Fire Rescue Commissioner
Author:
Not specified
Target audience:
Applicants for ‘Pre-129 Letter of Advice’ and ‘Formal Report and Consent Pursuant to Regulation 129 (1)’
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Note:
Year
Subject:
Pharmaceutical Regulatory Submissions
Document type:
Checklist
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Identification number:
ZL300_00_003
Version:
20.0
Valid from:
01.02.2026
External reference (Company Reference):
……
Authorisation no.:
……
Basic company dossier no.:
……
Name of medicinal product:
……
Active substance(s):
……
Pharmaceutical form:
……
Reference medicinal product:
……
Authorisation no. of the reference medicinal product:
……
Name of the foreign comparator product:
……
Indications:
……
Pharmacotherapeutic group:
……
ATC code:
……
Dosage strength(s):
……
Primary container:
……
Secondary container:
……
Product category:
……
Dispensing category:
……
Information on the Swiss reference medicinal product:
……
Information on the foreign comparator product:
……
Marketing authorisation holder:
……
Company meetings:
……
Was a company meeting conducted for this application? Meeting before application submission:
……
Extended document protection:
……
Year:
2025
Region / city:
Switzerland
Theme:
Medicinal products, regulatory procedures
Document type:
Application form
Author:
Not specified
Target audience:
Pharmaceutical companies, regulatory authorities
Period of validity:
From 01.02.2025
Approval date:
Not specified
Amendment date:
Not specified
Year:
2023
Region / City:
Northern Canadian Cordillera
Topic:
Seismology, Geophysics
Document Type:
Research Article
Author:
Derek L. Schutt, Robert W. Porritt, Clément Estève, Pascal Audet, Jeremy Gosselin, Andrew Schaeffer, Richard C. Aster, Jeffrey T. Freymueller, Joel F. Cubley
Target Audience:
Geophysicists, Seismologists, Researchers in Earth Sciences
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Jurisdiction:
Victoria, Australia
Regulatory framework:
Regulation 129 (1) and Regulation 129 (3)
Related standards:
National Construction Code; Australian Standards
Subject matter:
Building fire safety compliance and variations
Document type:
Application template
Issuing authority:
Fire Rescue Commissioner
Intended use:
Submission accompanying applications for regulatory assessment
Format:
Word document
Contact details:
[email protected]
Note:
; (03) 9665 4478
Note:
Year
Subject:
Pharmaceutical Product Notification
Document Type:
Notification Form
Organization / Institution:
Food and Drug Administration
Target Audience:
Pharmaceutical companies and their representatives
Year:
2018
Region / city:
Austria
Subject:
Human rights violations, intersex genital mutilations, children
Document type:
NGO Report
Institution:
StopIGM.org / Zwischengeschlecht.org
Author:
Markus Bauer, Daniela Truffer
Target audience:
Human rights organizations, UN committees, healthcare professionals, policymakers
Effective period:
Ongoing
Approval date:
July 2018
Modification date:
Not specified
Year:
2021
Region / city:
Mali
Theme:
Cotton research, agricultural productivity
Document type:
Research article
Organization / institution:
University of Sciences, Techniques and Technologies of Bamako, Institute of Rural Economy, Cotton Program
Author:
Sory Sissoko, Mariam Traoré, Elhadji Mamoudou Kassambara, Gassiré Bayoko, Daouda Maiga, Mamadou And Oumar Diawara
Target audience:
Researchers, agricultural professionals, cotton producers
Effective period:
2019
Approval date:
Not specified
Date of changes:
Not specified
Date:
10 January 2025
Region / city:
EU
Topic:
Veterinary Medicines
Document Type:
Pre-submission meeting request form
Organization / institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target audience:
Marketing authorisation holders, applicants
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Context:
Pre-submission meeting request form to obtain procedural and regulatory advice for veterinary medicinal products subject to variation requiring assessment (VRA).