№ lp_1_2_18699
File format: docx
Character count: 32647
File size: 201 KB
Structured template for regulatory assessment of pharmaceutical product applications including product identification, quality evaluation, manufacturing details, and relevant documentation references.
Reference:
HM/QP/003
Type of document:
Regulatory evaluation template
Scope:
Finished Pharmaceutical Products (FPP) and Active Pharmaceutical Ingredients (API)
Regulatory body:
ZAMRA (Zambia Medicines Regulatory Authority)
Content focus:
Quality, labelling, manufacturing, and stability assessment
Submission date:
As indicated per application
Evaluators:
As assigned in document
Application number:
As specified in submissions
ATC code / Pharmacological classification:
Provided per product
Dosage form:
Specified per product
Route of administration:
Specified per product
Applicant:
Name and address provided per submission
Manufacturing site:
Name and address of FPP and API manufacturers
GMP compliance:
Status indicated per site
Reference standards:
CEP, DMF, pharmacopeial monographs cited
Evaluation sections:
Summary of Product Information, Quality Evaluation of Labelling and Samples, Drug Substance details, Manufacturing process, Analytical procedures, Stability data
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
Global
Topic:
Environmental and Social Impact in Evaluations
Document Type:
Consultancy Request
Organization / Institution:
United Nations Evaluation Group (UNEG), Global Environment Facility (GEF)
Author:
UNEG Working Group on Climate Change and Environment
Target Audience:
Consultants, UNEG members, Evaluation Practitioners
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / city:
United States
Topic:
Training Evaluation
Document type:
Template
Institution:
Centers for Disease Control and Prevention
Author:
CDC Training and Evaluation Team
Target Audience:
Training developers, evaluators, and learners
Duration:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2021
Region / City:
North Dakota, USA
Topic:
Promotion and Tenure Evaluation Guidelines
Document Type:
Policy Guidelines
Institution:
North Dakota State University, College of Engineering
Author:
Department of Industrial and Manufacturing Engineering
Target Audience:
Faculty Members, Academic Committees
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Revisions:
Not specified
Year:
2024
Region / city:
United States
Topic:
Visual Impairment, Assessment, Psychological Evaluation
Document Type:
Guidelines
Organization / institution:
American Printing House
Author:
Jennifer Aileen Engle, May Thien Nguyen, Stephen A. Goodman, Carol Evans, Marnee Loftin
Target audience:
Professionals in psychology, occupational therapy, speech-language pathology
Period of action:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2022
Region / city:
Washington, DC
Subject:
Pesticide evaluation, neonicotinoids, environmental effects
Document type:
Response to public comments
Organization:
U.S. Environmental Protection Agency
Author:
Environmental Protection Agency (EPA)
Target audience:
Stakeholders, regulatory bodies, environmental organizations, public
Period of validity:
Indefinite
Approval date:
June 2022
Date of changes:
None specified
Year:
2019
Region / City:
Stafford, VA
Subject:
Annual Workplace Evaluations
Document Type:
Request for Information (RFI)
Agency:
Department of Veterans Affairs
Author:
Antionette Collins-Somerville
Target Audience:
Contractors, Service-Disabled Veteran-Owned Small Businesses, Veteran-Owned Small Businesses
Contracting Office:
National Cemetery Administration, Department of Veterans Affairs
Period of Action:
Not specified
Date of Approval:
Not specified
Date of Changes:
Not specified
Note:
Year
Document Type:
Court Order
Organization / Institution:
DBHDD
Note:
Year
Jurisdiction:
California
Subject area:
Medical-legal psychiatric evaluations
Document type:
Quality assurance checklist and reference guide
Legal context:
Workers’ Compensation
Applicable professionals:
QMEs, AMEs, IMEs, PTPs
Governing regulations:
California Code of Regulations §§35.5, 40; Labor Code §3208.3
Issuing context:
Division of Workers’ Compensation
Authors:
Steven D. Feinberg, MD; Nicole L. Richardson, Esq.; Robert G. Rassp; Saul Allweiss; Vladimir Bokarius, MD, PhD; Joshua Kirz, PhD; Bobbie McDonald, PsyD; David E. Sones, MD; Julius Young
Geographic scope:
California
Intended use:
Medical-legal reporting in workers’ compensation cases
Source type:
Professional guideline and checklist
Year:
2026
Organization:
NAIC Innovation, Cybersecurity and Technology (H) Committee
Type of document:
Regulatory guidance / Supplementary tool
Audience:
State insurance regulators
Topics:
Artificial intelligence, machine learning, insurance risk assessment, consumer protection
Sections:
Exhibit A – Quantify Regulated Entity’s Use of AI Systems; Exhibit B – AI Systems Governance Risk Assessment Framework; Exhibit C – AI Systems High-Risk Model Details; Exhibit D – AI Systems Model Data Details
Scope:
Financial and consumer risk evaluation of AI systems usage in insurance companies
Year:
2023
Region / City:
United States
Subject:
Artificial Intelligence, Insurance, Risk Management
Document Type:
Regulatory Tool
Institution:
National Association of Insurance Commissioners (NAIC)
Author:
Big Data and AI Working Group (BDAIWG)
Target Audience:
State Regulators, Insurance Companies
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2025
Region / City:
Not specified
Theme:
Access keys, staff management, MDS evaluations
Document type:
Guideline
Organization:
Riverside Insights
Author:
Not specified
Target audience:
Staff involved in MDS evaluations
Period of validity:
Through December 31, 2027
Approval date:
Not specified
Date of modifications:
Not specified
Year:
2021
Region / City:
Idaho
Topic:
Transportation, Software Development
Document Type:
Research Proposal
Institution:
Idaho Transportation Department
Author:
Idaho Transportation Department
Target Audience:
Contractors, Software Developers, Research Program Stakeholders
Period of Validity:
Until completion of project
Approval Date:
February 26, 2021
Date of Modifications:
N/A
Note:
Date
To:
Parent(s)/guardian(s)/adult student
Year:
Not specified
Region / City:
Not specified
Topic:
Special education consent
Document Type:
Consent Form
Organization / Institution:
Office of Superintendent of Public Instruction
Author:
Not specified
Target Audience:
Parents/guardians/adult students
Effective Period:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2019
Region / city:
Ireland
Topic:
Investment company, liquidation
Document type:
Consultation Paper
Institution:
Central Bank of Ireland
Author:
Central Bank of Ireland
Target audience:
Investment companies, financial institutions
Period of validity:
Indefinite until revocation
Date of approval:
July 2019
Date of amendments:
N/A
Purpose:
Outline of the appeal process for reviewable decisions
Jurisdiction:
South Australia
Scheme:
South Australian Restrictive Practices Authorisation scheme
Legal basis:
Disability Inclusion Act 2018 (Part 6A, ss. 23L, 23N, 23O, 23P, 23Y, 23Z)
Regulations:
Disability Inclusion (Restrictive Practices – NDIS) Regulations 2021, s. 14
Document type:
Administrative procedure
Responsible unit:
Restrictive Practices Unit
Decision-makers:
Authorised Program Officer; Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Scope:
Appeals of reviewable decisions relating to restrictive practices
Target audience:
RPU staff, people with disability, family members, NDIS service providers
Appeal timeframe:
30 days from original decision, with possible extension
Review bodies:
Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Source type:
Government administrative procedure governing appeals and reviews of restrictive practice authorisation decisions within the South Australian NDIS regulatory framework.
Note:
Year
Theme:
Special Religious Education, Child Protection
Document Type:
Authorisation Letter
Organisation / Institution:
Department of Education
Target Audience:
Approved Providers, School Coordinators
Year:
2024
Region / City:
Malta
Topic:
ICT Third-Party Service Providers
Document Type:
Regulatory Form
Organization / Institution:
Malta Financial Services Authority (MFSA)
Author:
Malta Financial Services Authority (MFSA)
Target Audience:
Financial entities applying for authorisation from MFSA
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2003
Jurisdiction:
Victoria, Australia
Document type:
Application form / Regulatory form
Regulation:
Cemeteries and Crematoria Regulations 2025, Regulation 30
Issuing authority:
Victorian Government
Related legislation:
Births, Deaths and Marriages Registration Act 1996; Coroners Act 2008; Privacy and Data Protection Act 2014; Public Records Act 1973
Purpose:
Authorisation of cremation for deceased persons
Attachments required:
Notice of death, Certificate of registered medical practitioner, Coroner’s order, notice of still-birth (if applicable)
Penalties:
False statements punishable under section 132 of the Cemeteries and Crematoria Act 2003
Applicant type:
Natural person or corporate body
Cremation details:
Name of crematorium, date of cremation, place and type of interment
Contact information:
Applicant and funeral director details, including address, telephone, and email