№ lp_1_2_34767
File format: docx
Character count: 29958
File size: 200 KB
This document is a regulatory form for manufacturers to provide detailed information about their manufacturing processes, including the production of active substances, quality control, and packaging for medicinal products, submitted to Swissmedic for approval and monitoring.
Year:
2099
Region / City:
Bern
Subject:
Pharmaceutical Manufacturing
Document Type:
Regulatory Submission
Organization / Institution:
Swissmedic
Author:
Swissmedic
Target Audience:
Pharmaceutical Manufacturers, Regulatory Authorities
Period of Validity:
10.09.2023–01.01.2099
Approval Date:
01.01.2099
Date of Changes:
N/A
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2019
Region / City:
Global
Subject:
Technical Specifications for Vehicle Manufacturers
Document Type:
Amendment
Organization:
Automotive Industry Standards
Author:
Not specified
Target Audience:
Vehicle Manufacturers, Engineers, Technical Specialists
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Revision:
04/2019
Year:
2025
Region / City:
USA
Subject:
Medicare Part B Drugs and Biologicals ASP Data Reporting
Document Type:
Regulatory
Organization / Institution:
Centers for Medicare & Medicaid Services (CMS)
Author:
Centers for Medicare & Medicaid Services (CMS)
Target Audience:
Manufacturers of Medicare Part B Drugs and Biologicals
Period of Effect:
From January 1, 2022
Approval Date:
Not specified
Amendment Date:
November 5, 2025
Year:
[year]
Region / City:
[location]
Theme:
Endorsement, Licensing, Athlete Sponsorship
Document Type:
Agreement
Organization / Institution:
[company]
Author:
[name of author or company]
Target Audience:
Businesses, Legal Professionals, Marketing Agencies
Validity Period:
[start date] – [end date]
Approval Date:
[date]
Amendment Date:
[date]
Year:
2023
Region / city:
Bern
Theme:
Pharmaceutical product manufacturer information
Document type:
Regulatory form
Authority / institution:
Swissmedic
Author:
Swissmedic
Target audience:
Pharmaceutical companies, regulatory authorities
Validity period:
11.09.2023 - 01.01.2099
Approval date:
01.01.2099
Amendment date:
Not specified
Year:
2014
Region / city:
Pune
Theme:
Automotive industry standards
Document type:
Technical specification document
Authority / organization:
Automotive Industry Standards Committee, Ministry of Road Transport and Highways
Author:
Automotive Research Association of India
Target audience:
Vehicle manufacturers, construction equipment vehicle manufacturers, agricultural tractor manufacturers
Period of validity:
Indefinite
Approval date:
June 2014
Date of changes:
March 2014
Document Type:
Standardized manufacturer disclosure form and instruction guide
Issuing Organization:
HIMSS Medical Device Security Workgroup
Related Regulation:
HIPAA Security Rule, 45 CFR Part 164
Referenced Deadline:
April 21, 2005
Subject:
Security features of medical devices handling electronic Protected Health Information (ePHI)
Scope:
Administrative, physical, and technical safeguards for medical devices
Intended Audience:
Healthcare provider organizations and medical device manufacturers
Purpose:
Disclosure of device-specific security attributes and ePHI management capabilities
Referenced Publication:
Information Security for Biomedical Technology: A HIPAA Compliance Guide (ACCE/ECRI, 2004)
Geographical Relevance:
United States and international healthcare regulatory environments
Year:
2022
Region / city:
China
Theme:
Food and Drink Regulation
Document Type:
Guidelines
Author:
CBBC
Target Audience:
Overseas food manufacturers, exporters to China
Period of Validity:
Ongoing
Approval Date:
1st January 2022
Amendment Date:
None
Year:
2020
Region / city:
Malaysia
Topic:
Business expansion, diversification, and incentive application for manufacturing
Document type:
Application form
Organization:
Malaysian Investment Development Authority (MIDA)
Author:
Malaysian Investment Development Authority (MIDA)
Target audience:
Companies applying for incentives or expatriate posts in Malaysia
Period of validity:
Ongoing from 1/7/2020
Approval date:
Not specified
Date of changes:
Not specified
Context description:
A business application form used to apply for incentives or expatriate posts in Malaysia for expansion or diversification projects by licensed or non-licensed manufacturers.
Year:
2010
Region / city:
UK
Topic:
Construction / Building materials
Document type:
Product specifications
Organization / institution:
Crittall Windows Limited
Author:
Crittall Windows Limited
Target audience:
Construction professionals, Architects
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2023
Registration Submittal Date:
October 7, 2022
Jurisdiction:
District of Columbia
Subject:
Covered Electronic Equipment (CEE) Manufacturer Registration
Document Type:
Registration Form
Issuing Authority:
Department of Energy & Environment (DOEE)
Program:
eCYCLE DC
Applicable Law:
D.C. Official Code § 8-1041.05
Registration Deadline:
December 31, 2022
Program Period:
January 1, 2023 – December 31, 2023
Registration Fee:
$828.07 (100–249 units sold in 2021); $2,925.84 (250 or more units sold in 2021)
Submission Method:
Electronic submission via email or online portal
Target Audience:
Manufacturers of Covered Electronic Equipment selling in the District of Columbia
Year:
2021
Region / city:
N/A
Theme:
Pressure Vessel Manufacturing
Document Type:
Certification Report
Organization / Institution:
ASME
Author:
N/A
Target Audience:
Manufacturers, Inspectors, Engineers
Period of Validity:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2024
Region / City:
UAE
Theme:
MEP Industry
Document Type:
Nomination Form
Organization:
CIBSE UAE
Author:
CIBSE
Target Audience:
Senior Executives, Engineers, Manufacturers, Suppliers
Period of Activity:
1st September 2023 – 1st September 2024
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
State:
New York
Contract Title:
Information Technology Umbrella Contract – Manufacturer Based (Statewide)
Group:
73600
Award Number:
22802
Contract Number:
PM68149
Lots:
Lot 1 – Software; Lot 2 – Hardware; Lot 4 – Implementation
Contractor:
Konica Minolta Business Solutions U.S.A., Inc.
Contractor Address:
1595 Spring Hill Road, Suite 410, Vienna, VA 22182
Federal ID Number:
13-1921089
NYS Vendor Number:
1000006138
Procurement Card Accepted:
Yes
Prompt Payment Discount (15 days):
0%
Prompt Payment Discount (30 days):
0%
Contract Administrator:
Valarie Rock, State Contract Supervisor
Account Manager:
Mace Coleman, Government Account Manager
Participating Resellers:
Multiple authorized resellers listed statewide in New York
Sales Agents:
None
Year:
2026
Region / city:
United Kingdom
Topic:
Good Manufacturing Practice, Advanced Therapy Medicinal Products (ATMPs)
Document type:
Consultation response
Organization / institution:
NHS Advanced Therapy Medicinal Products Working Party
Author:
Anne Black
Target audience:
Pharmaceutical professionals, regulatory bodies, academic researchers
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
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:
2017
Regulation:
EU No 536/2014
Document type:
Template
Topic:
Investigational Medicinal Products (IMP)
Regulatory reference:
Article 62(1) of Regulation (EU) No 536/2014
Manufacturer:
Not specified
Certification authority:
Qualified Person (QP)
Target audience:
Manufacturers, sponsors, regulatory bodies
Purpose:
Harmonisation of batch release certification
Approval date:
Not specified
Modification date:
Not specified
Context:
Template for certification of investigational medicinal products batch release for clinical trials, ensuring compliance with EU regulations on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Note:
Year
Theme:
Medicinal product registration
Document type:
Application form
Organization:
Swissmedic
Target audience:
Pharmaceutical companies, Regulatory authorities
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English