№ lp_1_35053
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Checklist of required information for submitting a dossier for listing a new medicine or new indication in the Ministry of Health Malaysia Medicines Formulary.
Note: Year
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Dossier of the Joint Clinical Assessment of a Medicinal Product
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.
Annex 1 to Guidance on filling in the JCA dossier template of a Medical Device - Table template collection V1.028 NOVEMBER 2025
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
Table of Contents for MIV-1 Variation Dossier Checklist
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
Table of Contents for MIV-1 Variation Dossier Requirements
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
Quality Overall Summary: Product Dossier (QOS-PD)
Note: Year
APPROVED Order of the Ministry of Health of Ukraine №_______ Requirements to Module 1 electronic common technical document (eCTD) specification with recommendations for submitting registration dossier materials in electronic common technical document (eCTD)
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
Fleet Maintenance Software Dossier On-Demand Portal User Guide
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
Position Paper Proposal to Applicants DOSSIER PROCESSING FEES
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
CLA P&T Dossier Instructions for sections submitted by candidate
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.
Active Substance / Ingredient Product Chemistry Evaluation (based on OECD Dossier Numbering)
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
PART B: CHECKLIST ON DOSSIER REQUIREMENTS FOR MIV-2 APPLICATION
Note: Year
Checklist of Information to be Included in Dossier D3
Note: Year
Dossier D4 to Add Medicines/Indication Listed in the MOH Medicines Formulary into Institution’s Medicines Formulary
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.
Dossier for Listing New Medicine(s) into the MOH Medicines Formulary
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
Annex 1 to Guidance on filling in the JCA dossier template of an In vitro Diagnostic Medical Device -Table template collectionV1.028 November 2025Adopted on 28 November 2025 by the HTA CG pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 on Health Technology Assessment
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
Project Study Report-Project Development Support (PSR-PDS)ToRequest Programming for Capital Support(Project Approval and Environmental Document Phase) (in the 20__ STIP)*(*For a locally sponsored project, this language may not be included or may need to be modified.)
Year: 20__
Note: Region/City
Document Type: Project Study Report
Guidance on using this template: RED text offers choices; choose the appropriate text that applies and delete the other. BLUE text is hyperlinks to web pages. GREEN text instructs the writer of action to be taken or informs the writer of important information. BLACK text is to be included in the document. Delete all green text and this guidance page prior to finalizing this document.
Year: 2023
Region / City: New York State
Theme: Cultural Resource Management
Document Type: Template for Historic Preservation Finding Document
Agency / Institution: New York State Department of Transportation (NYSDOT)
Author: Not specified
Target Audience: Project managers, cultural resource coordinators, historical preservation professionals
Period of Validity: Not specified
Approval Date: Not specified
Date of Changes: Not specified
Note to Specifier: This document is published by Sterling Solutions. Orange text contains notes to the specifier and is not intended to be included in the final specifications. Bold text contains potential specification language suggested to be finalized for the project.SECTION 06 17 15 – Cross-Laminated Timber PanELS
Year: 2022
Region / City: N/A
Topic: Cross-Laminated Timber Panels
Document Type: Technical Specification
Organization / Institution: Sterling Solutions
Author: N/A
Target Audience: Specifiers, Architects, Engineers
Period of Validity: N/A
Approval Date: N/A
Revision Date: N/A
Title of Chapter:Subtitle of ChapterYour chapter must be PROFESSIONALLY COPY EDITED before the FINAL SUBMISSION of your manuscript.Failure to do so may result in exclusion from the upcoming publication.Please contact your Development Editor with questions or concerns.Note: Open access manuscripts with fully paid open access processing charges will automatically undergo professional English language copy editing and proofreading prior to final publicationNote: IGI Global highly recommends eContent Pro International to its authors and editors for supplemental editorial services, including English language copy editing. Learn MoreAuthor NameAffiliation, Country(Institution name, Country - No departments. No city unless included in the institution’s name.)
Note: en
Year: 2014
Topic: Academic publishing, editing, and manuscript preparation
Document type: Guidelines for authors
Organization / Institution: IGI Global
Target audience: Authors and editors preparing academic chapters for publication
Biennial Update Report (BUR) Template Compliant with the UNFCCC Biennial Update Reporting Guidelines for Parties not included in Annex I to the Convention
Year: 2021
Region / city: Bonn and Eschborn, Germany
Theme: Climate Change, International Cooperation, Reporting Guidelines
Document Type: Template
Organization: Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH
Author: GIZ
Target audience: Non-Annex I Parties to the UNFCCC
Period of validity: Ongoing
Approval date: December 2021
Modification date: None
Topics: Dossier included Checklist