№ lp_1_23862
File format: docx
Character count: 12632
File size: 37 KB
A checklist for the submission of type II quality variations related to marketing authorization applications, detailing specific requirements and documentation for variations such as manufacturing sites or quality control testing sites.
Note:
Year
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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
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
Year:
2004
Region / City:
International
Topic:
Process Validation, Medical Device Manufacturing
Document Type:
Guideline
Organization / Institution:
Philips
Author:
Philips Quality Engineering
Target Audience:
External suppliers, manufacturers of medical devices
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Khyber Pakhtunkhwa
Theme:
Digital Governance, Workflow & Document Management System, Third-Party Validation
Document Type:
Terms of Reference
Organization / Institution:
Khyber Pakhtunkhwa Revenue Mobilization & Public Resource Management Program (KPRMP)
Author:
KPRMP
Target Audience:
Third-Party Firms, IT Consultants, and Government Agencies
Period of Validity:
06 months
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
Terms of Reference for engaging a third-party firm to validate the deliverables submitted by Netsol Technologies in the development of a Workflow & Document Management System for the Khyber Pakhtunkhwa government.
Note:
and the site visit team chair eight (8) weeks prior to the site visit)(4.2024)
Year:
2024
Region / City:
N/A
Theme:
Accreditation
Document Type:
Schedule Template
Organization / Institution:
ARC-PA
Author:
N/A
Target Audience:
Program administrators, Site visit team
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / City:
United Kingdom
Topic:
Woodland Carbon Code, Project Validation
Document Type:
Project Design Document (PDD)
Organization / Institution:
UK Land Carbon Registry
Author:
Vicky West
Target Audience:
Project or Group Managers seeking Woodland Carbon Code validation
Period of Action:
Ongoing until project completion
Approval Date:
April 2024
Date of Amendments:
April 2024