№ lp_1_31581
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Character count: 17001
File size: 56 KB
The document provides a checklist outlining requirements for dossier submissions for variations to MIV-2 applications, detailing specific changes to product names, labelling, and specifications in compliance with regulatory guidelines.
Note:
Year
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Note:
Year
Topic:
Pharmaceutical Regulatory Process
Document Type:
Checklist
Target Audience:
Regulatory authorities, pharmaceutical companies
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / city:
Singapore
Topic:
Pharmaceutical manufacturing and regulatory requirements
Document type:
Regulatory guideline
Organization:
Health Sciences Authority
Author:
Health Sciences Authority
Target audience:
Pharmaceutical manufacturers, regulatory professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2026
Region / City:
Singapore
Subject:
Pharmaceutical Manufacturing and Regulatory Compliance
Document Type:
Regulatory Guidelines
Organization:
Health Sciences Authority (HSA)
Author:
Health Sciences Authority
Target Audience:
Pharmaceutical Manufacturers, Regulatory Affairs Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
eCTD, registration dossier, Ministry of Health of Ukraine
Document Type:
Order
Organization / Institution:
Ministry of Health of Ukraine
Target Audience:
Regulatory authorities, applicants for medicinal product registration
Year:
2015
Region / City:
Burlington, NJ
Topic:
Fleet Management Software
Document Type:
User Guide
Organization:
Dossier Systems, Inc.
Author:
Dossier Systems, Inc.
Target Audience:
Fleet Maintenance Managers, IT Administrators
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2022
Region / City:
SADC region
Topic:
Medicine Regulatory Harmonization
Document Type:
Position Paper
Organization / Institution:
SADC Medicines Regulatory Forum (SADC MRF)
Author:
T. Sithole, G. Mahlangu, S. Walker, S. Salek
Target Audience:
Regulatory authorities, pharmaceutical industry, applicants
Period of Validity:
Up to 12 months from issuance of recommendation
Date of Approval:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Academic Promotion and Tenure
Document Type:
Instructional Guidelines
Organization / Institution:
Auburn University
Target Audience:
Faculty, Department Chairs, University Administrators
Context:
Instructional guidelines for faculty members preparing their dossiers for promotion and tenure evaluations.
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Subject:
Medicine Formularies, Health Policy
Document Type:
Form, Application
Institution:
Ministry of Health
Author:
Applicant (Consultant, Specialist, Medical Officer, Pharmacist)
Target Audience:
Healthcare Professionals, Drug and Therapeutic Committee
Context:
Form used to propose the inclusion of a medicine or indication from the Ministry of Health Medicines Formulary into an institution’s Medicines Formulary for approval by the institution’s Drug and Therapeutic Committee.
Year:
Not specified
Region / City:
Malaysia
Topic:
Pharmaceutical registration and formulary listing
Document Type:
Application Form
Organization / Institution:
Ministry of Health Malaysia
Author:
Not specified
Target Audience:
Pharmaceutical companies, regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2025
Region / city:
European Union
Topic:
Health Technology Assessment (HTA)
Document type:
Guideline / Supplementary material
Author:
HTA CG
Target audience:
Health technology assessors, clinical researchers
Period of validity:
Not specified
Approval date:
28 November 2025
Modification date:
Not specified
Year:
2022
Region / City:
United States
Theme:
Military Recruitment
Document Type:
Federal Notice
Organization:
National Guard Bureau
Author:
National Guard Bureau
Target Audience:
Applicants to the Army National Guard
Period of Action:
Ongoing
Approval Date:
June 22, 2022
Amendment Date:
Not specified
Year:
2021
Region / City:
United Kingdom
Subject:
Teacher Conduct and Professionalism
Document Type:
Educational Standards
Organization / Institution:
Department for Education (DfE)
Author:
Department for Education
Target Audience:
Newly Qualified Teachers, Educators
Period of Validity:
Ongoing
Approval Date:
2021
Date of Changes:
N/A
Year:
2023
Region / City:
United States
Topic:
Early Intervention Services, Disabilities
Document Type:
Instructions, Performance Report
Organization / Institution:
State Government, Lead Agency
Author:
U.S. Department of Education
Target Audience:
State Governments, Early Intervention Service Providers
Period of Effectiveness:
FFY 2023
Approval Date:
February 1, 2025
Date of Changes:
N/A
Year:
2025
Location:
Spalding, Lincs, PE11 2XL
Topic:
Heritage Impact Assessment, Listed Building Consent
Document Type:
Report
Institution:
South Holland District Council
Author:
Jonathan Biggadike
Target Audience:
Local Planning Authority, Heritage Consultants
Period of Validity:
Not specified
Approval Date:
18th March 2025
Amendment Date:
Not specified