№ lp_1_2_13800
File format: docx
Character count: 29958
File size: 199 KB
This document is a regulatory form used to provide detailed manufacturer and test laboratory information for medicinal products as required by Swissmedic.
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
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:
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
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