№ lp_1_2_15525
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File size: 708 KB
This document provides a detailed form used by pharmaceutical companies to apply for variations or extensions in the authorisation of medicinal products in Switzerland.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
2024
Region / City:
West Ham Park, Newham, London
Document Type:
Public Information Leaflet
Issuer:
Newham Council
Target Audience:
Local residents, businesses, community groups, stakeholders
Implementation Period:
November 2024 – Experimental phase
Related Initiatives:
20mph speed limit programme, traffic calming measures
Public Engagement Period:
March 2023 – Summer 2024
Survey Responses:
421 comments from perception survey, 664 in-person survey participants, 200 businesses engaged
Asset number:
0001188
Location:
Tokyo
Update date:
Aug 2022
Process:
Hardware Asset Management (HAM)
Platform:
ServiceNow
Type of document:
Process guide
Scope:
Management of hardware asset lifecycle within ServiceNow
Related processes:
Change Management, Incident Management, Request Fulfilment, Configuration Management, Procurement Management, Contract Management, Vendor Management
Includes:
RACI Matrix, Lifecycle Description, KPIs, Glossary of Terms and Acronyms
Lifecycle stages covered:
Request, Procurement, Receipt, Installation, Move/Add/Change, Validation, Retirement, Disposal
Compliance reference:
US Sarbanes-Oxley requirements
Process owner:
Asset Management Process Owner
Year:
2023
Region / City:
Not specified
Topic:
Cooking / Recipes
Document type:
Recipe Collection
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
General public interested in cooking
Period of validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Subject:
Paediatric orthopaedics
Document Type:
Medical research
Institution:
University of Southampton
Author:
Georgia Walker
Target Audience:
Medical professionals
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:
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
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.
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).
Document Section:
Appendix A
Amendment Year:
2018
Jurisdiction:
United States
Subject:
Package regulations and net quantity compliance requirements
Document Type:
Regulatory tables and sampling plans
Responsible Agencies:
U.S. Department of Agriculture; U.S. Food and Drug Administration; Federal Trade Commission; Alcohol and Tobacco Tax and Trade Bureau; U.S. Environmental Protection Agency; State and local weights and measures authorities
Referenced Standard:
NIST Handbook 133
Commodities Covered:
Meat; Poultry; Siluriformes; Foods; Drugs; Cosmetics; Tobacco; Alcohol Products; Pesticides; Non-food Consumer Products
Key Provisions:
Sampling Plans for Category A and Category B; Maximum Allowable Variations (MAVs); Tare Sample Determination; Exceptions to MAVs
Application Scope:
Inspection lots and packaged goods in commerce