№ lp_2_3_20348
File format: docx
Character count: 10460
File size: 57 KB
Structured application form for submission to WHO PQTm to prequalify an active pharmaceutical ingredient, including details on API, manufacturers, site master files, GMP compliance, and regulatory history.
Year:
2026
Document type:
Application form
Subject:
Prequalification of Active Pharmaceutical Ingredient (API)
Organization:
World Health Organization Prequalification Team (PQTm)
Applicant:
[Company name from application]
Contact person:
[Name and position from application]
API manufacturer:
[Name and address from application]
API intermediate manufacturer(s):
[Names and addresses from application]
Site Master File (SMF) included:
Yes / No (depending on submission)
GMP compliance evidence:
Included / Requested inspection
Relevant standards:
ICHQ7, ICHQ3D, Pharmacopoeial standards
Other regulatory agencies involved:
EDQM, US FDA, other authorities if listed
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024-2025
Region / City:
Texas
Subject:
Flood Infrastructure
Document Type:
Application
Authority:
Texas Water Development Board (TWDB)
Author:
N/A
Target Audience:
Entities applying for flood infrastructure funds
Period of Action:
2024-2025
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / city:
Perth
Topic:
Transport research
Document type:
Submission guidelines
Organ / institution:
ATRF 2023 conference
Author:
Primary Author, Secondary Author
Target audience:
Researchers, conference participants
Effective period:
Until the conference submission deadline
Note:
Approval date
Year:
2024
Organization:
Digital Health and Care Wales (DHCW)
Committee:
Audit and Assurance Committee
Document type:
Meeting minutes
Location:
MS Teams / Wales, UK
Chair:
Marian Wyn Jones
Attendees:
Members of Audit and Assurance Committee, Executives, Auditors
Apologies:
Mike Whiteley, Audit Wales
Topics covered:
Preliminary matters, Audit and Risk, Governance Reports, Closing Matters
Decisions recorded:
Approval of previous minutes, Audit Action Tracker updates, Internal Audit reports noted, Losses and Special Payments reviewed, Raising Concerns report noted
Next meeting:
21 January 2025
Confidentiality:
Private/Abridged
Program:
State Water Implementation Fund for Texas (SWIFT)
Organizing Institution:
Texas Water Development Board
Country:
United States
State:
Texas
Document Type:
Application Form
Submission Method:
Email or Online Loan Application System
Application Deadline:
February 1, 2022
Contact Email:
[email protected]
Related Planning Documents:
2022 State Water Plan; 2021 Regional Water Plan
Project Phases Covered:
Planning; Acquisition; Design; Construction
Subject Area:
Water Infrastructure and Water Supply Projects
Required Information:
Project description, planning references, population served, cost estimates, water production or conservation volumes, readiness to proceed, household cost factor
Financial Components:
Low-interest Loan; Deferred Loan; Board Participation; Local Contribution; Other Funding Sources
Target Applicants:
Water utilities, public water systems, and regional water supply project entities
Attachments Required:
Agricultural conservation methodology; multi-year commitment schedule; debt service structure explanation
Year:
2024
Region / city:
United Kingdom
Theme:
Organic food certification
Document type:
Form
Organization / institution:
Soil Association
Author:
Soil Association
Target audience:
Companies submitting products for certification
Effective period:
From September 2025
Approval date:
Not specified
Amendment date:
March 2024
Year:
2024
Region / City:
United Kingdom
Subject:
Multi-ingredient product submission form
Document Type:
Form
Organization / Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies submitting multi-ingredient products
Effective Period:
From September 2025
Approval Date:
Not specified
Amendment Date:
March 2024
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
Year:
2024
Region / city:
United Kingdom
Topic:
Food & Drink Certification
Document Type:
Form
Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies sourcing multi-ingredient food products
Period of Validity:
Until September 2025
Approval Date:
March 2024
Date of Changes:
September 2025
Year:
2022
Region / City:
Rwanda
Subject:
Pharmaceutical manufacturing, GMP inspection
Document Type:
Form
Organ / Institution:
Rwanda Food and Drugs Authority
Author:
N/A
Target Audience:
Pharmaceutical manufacturers
Period of validity:
20 June 2022 - 10 October 2025
Approval Date:
20 June 2022
Revision Date:
03 October 2022
Effective Date:
11 October 2022
Review Due Date:
10 October 2025
Year:
2020
Region / City:
Australia
Topic:
Health software, Active ingredient prescribing
Document Type:
Vendor Resource Document
Organization:
Medical Software Industry Association (MSIA)
Author:
MSIA in collaboration with The Australian Government Department of Health
Target Audience:
Prescribing software developers
Effective Period:
2020
Approval Date:
1 December 2020
Amendment Dates:
23/07/2019, 07/08/2019, 15/08/2019, 22/08/2019, 28/08/2019, 10/09/2019, 24/09/2019, 28/10/2019, 31/10/2019, 7/11/2019, 28/11/2019, 5/12/2019, 29/01/2020, 12/02/2020, 24/02/2020, 27/05/2020, 13/08/2020, 26/08/2020, 5/11/2020, 1/12/2020
Note:
Context Description
Note:
Year
Document Type:
Terms and Conditions
Organization:
Innovative Education Ltd.
Target Audience:
Schools
Context:
Terms and conditions document outlining the subscription, delivery, and service details for Classroom Kitchen Ingredient Delivery Service.
Note:
Year
Theme:
Pharmaceutical
Document Type:
Application form
Organization / institution:
World Health Organization (WHO)
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Context description:
A form for submitting an application to WHO for API prequalification, including details on manufacturing sites, GMP compliance, and nitrosamine risk assessment.
Year:
2026
Region / City:
Not specified
Topic:
Health / Antioxidants
Document Type:
Product Information
Organization / Institution:
E. EXCEL
Author:
Not specified
Target Audience:
Health-conscious individuals
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2021
Country:
Australia
Subject:
Active Ingredient Prescribing (AIP)
Document Type:
Fact Sheet
Related Programs:
Pharmaceutical Benefits Scheme (PBS); Repatriation Pharmaceutical Benefits Scheme (RPBS)
Issuing Authority:
Australian Government Department of Health
Effective Date:
1 February 2021
Target Audience:
Prescribers, pharmacists, consumers
Scope:
Hospital and community settings
Regulatory Context:
Legislative requirements for PBS and RPBS prescriptions
Contact:
[email protected]
Year:
2026
Region / City:
Hong Kong
Theme:
API Specification, Authentication, Web-Form Submission
Document Type:
Technical Specification
Organization / Institution:
The Government of the Hong Kong Special Administrative Region
Author:
Not specified
Target Audience:
External parties integrating software with ICRIS
Period of Validity:
Not specified
Approval Date:
2 Feb 2023
Modification Date:
25 Jan 2026
Year:
2024
Region / City:
Not specified
Topic:
LXI API, API extended functionality
Document Type:
Technical Specification
Organization / Institution:
LXI Consortium
Author:
LXI Consortium
Target Audience:
Developers, Engineers, Technicians
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Version:
1.0.12
Date:
3 Sep 2025
Organization:
The Government of the Hong Kong Special Administrative Region
Document Type:
API Specification
System:
Integrated Companies Registry Information System (ICRIS)
Target Users:
External software developers and system integrators
Amendment History:
Detailed version updates from 1.0 to 1.0.12 included
Content Format:
JSON for login/logout, XML for other API exchanges
Services Provided:
Submission and processing of various e-forms (NAR1, ND2A, ND2B, ND4, ND5, ND7, ND8, NNC1, NNC1G, NNC2, NR1, NSC1, NN3)
Authentication:
Token-based system with 30-minute validity
Password Policy:
TPSI password expires every 180 days
API Endpoint:
https://www.e-services.cr.gov.hk/ICRIS3EF
Year:
2011
Region / City:
Global
Subject:
Bing Search API, Azure Marketplace, Subscription Management
Document Type:
FAQ
Organization / Institution:
Microsoft
Author:
Microsoft
Target Audience:
Developers, Information Workers, Businesses using Bing Search API
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Version:
1.0
Last updated:
7/15/2016
Type of document:
API specification
Target audience:
Participating Organizations
Publisher:
CAQH
Scope:
ProView and DirectAssure Roster and Status Check services
Content coverage:
Add, Update, Delete providers; Status Check requests and responses
Year:
2023
Region / City:
North America
Topic:
API, Multi-Location Inventory
Document Type:
Developer Guide
Organization:
Amazon
Author:
Amazon Web Services
Target Audience:
Selling Partners, API Developers
Effective Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified