№ lp_2_1_00741
File format: docx
Character count: 3274
File size: 43 KB
Note:
Year
Subject:
Drug registration for local manufacture
Document Type:
Application form
Organization / Institution:
Ministry of Health
Author:
Applicant
Target Audience:
Pharmaceutical manufacturers
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2012
Region / city:
Pakistan
Topic:
Medical Device Regulation
Document Type:
Application Form
Organization:
Drug Regulatory Authority of Pakistan
Author:
Drug Regulatory Authority of Pakistan
Target Audience:
Manufacturers of medical devices
Validity Period:
Not specified
Approval Date:
Not specified
Date of Last Change:
Not specified
Year:
2021
Region / city:
Zoekfontein
Topic:
Hydropower system design and installation
Document type:
Technical specification
Organization / institution:
Rand Water
Author:
Rand Water Engineering Department
Target audience:
Contractors, engineers, and project managers
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Context:
This document outlines the detailed technical and functional requirements for designing, manufacturing, installing, and maintaining a hydropower plant at Zoekfontein Flow Control Works.
Year:
2021
Region / City:
South Africa
Topic:
Nuclear Energy, Bidding Process, Radiopharmaceutical Equipment
Document Type:
Invitation to Bid
Organization / Institution:
South African Nuclear Energy Corporation (Necsa)
Author:
Not specified
Target Audience:
Bidders for the specified project
Validity Period:
90 Days
Approval Date:
Not specified
Amendment Date:
Not specified
Clarification Session Date:
17 January 2022
Closing Date:
08 February 2022
Closing Time:
11:00 am
Contact Person:
Mr. Buyani Nsibande
Contact Email:
[email protected]
Contact Phone:
+27 (0) 12 305 6072
Year:
2021
Region / city:
South Africa
Subject:
Nuclear energy, radiopharmaceuticals, medical technology
Document type:
Invitation to bid
Organization:
South African Nuclear Energy Corporation (Necsa)
Author:
South African Nuclear Energy Corporation (Necsa)
Target audience:
Bidders, suppliers, contractors
Period of validity:
90 Days (Commencing the bid Closing Date)
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2021
Jurisdiction:
Czech Republic
Governing law:
Act No. 89/2012 Coll., Civil Code
Type of document:
Purchase contract
Buyer:
Nuclear Physics Institute of the Czech Academy of Sciences, public research institution
Seller:
Unspecified supplier selected through public procurement
Project:
European Spallation Source (ESS) – BEER instrument
Subject matter:
Manufacture and delivery of a safety shutter system
Funding source:
ESS project funds
Procurement procedure:
Below-the-limit public contract, open procedure
Related agreements:
In-Kind Contribution Agreement including Schedule NSS 6.6 #4
Annexes:
Technical specifications, project schedule, incentive and risk management instruments
Purpose:
In-kind contribution by the Czech Republic to ESS infrastructure
Legal status of buyer:
Non-entrepreneur in relation to the contract
Contractual priorities:
Buyer-favourable specifications prevail
Year:
2022
Country:
South Africa
Region / City:
North West Province, Pelindaba, Madibeng Municipality
Organization:
South African Nuclear Energy Corporation SOC Ltd
Bid number:
FBD-SCM-2022-TEN-0001
Document type:
Invitation to bid
Subject matter:
Procurement of a jaw crusher for a smelter project
Closing date:
13 May 2022
Closing time:
11:00
Compulsory site meeting date:
21 April 2022
Bid validity period:
90 working days
Delivery address:
Necsa Gate 3, Pelindaba, Brits Magisterial District
Applicable standards and policies:
ISO 14001, OHSAS 18001, ISO 9001, ISO 17025, RD 0034
Evaluation framework:
80/20 and 90/10 preference point systems
Contracting authority:
South African Nuclear Energy Corporation SOC Ltd
Contact person:
Buyani Nsibande
Bid number:
FIN-SCM-TEN-0053
Bid description:
Manufacture, supply, delivery, installation and commissioning of one jaw crusher for a smelter project
Issuing organization:
South African Nuclear Energy Corporation SOC Ltd
Document type:
Invitation to bid
Project:
Smelter project
Compulsory site meeting date:
18 April 2024
Compulsory site meeting location:
Necsa Site, Pelindaba
Closing date:
10 May 2024
Closing time:
11:00
Bid validity period:
90 working days from closing date
Delivery address:
Necsa Gate 3, R104 Elias Motsoaledi Street, Pelindaba, Brits Magisterial District, Madibeng Municipality, North West, 0240
Applicable legislation:
Preferential Procurement Policy Framework Act and Preferential Procurement Regulations, 2022
Evaluation criteria:
Functionality, B-BBEE, and price using 80/20 and 90/10 preference point systems
Scope of work:
Design, manufacture, supply, delivery, installation, commissioning, and training related to one jaw crusher
Year:
2019
Region / City:
International
Theme:
Advanced Therapy Medicinal Products, Biological Medicinal Substances
Document Type:
Consultation Notice
Organization:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Author:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Target Audience:
Stakeholders in the pharmaceutical industry, academia, hospitals, and experts in biotechnology and manufacturing
Period of Validity:
20 September 2019 – 20 December 2019
Approval Date:
20 September 2019
Revision Date:
20 December 2019
Year:
2019
Region / City:
International
Topic:
Consultation on GMP for Advanced Therapy Medicinal Products and Biological Medicinal Substances
Document Type:
Consultation Notice
Organization / Institution:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Author:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Target Audience:
Academia, hospitals, pharmaceutical industry, subject matter experts
Period of validity:
September 20, 2019 - December 20, 2019
Approval Date:
September 20, 2019
Date of Changes:
None specified
Document type:
Quality Technical Agreement
Subject:
Manufacture, overlabelling, importation, release and distribution of investigational medicinal products
Applicable regulations:
GMP, GDP, Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), ICH Good Clinical Practice, Declaration of Helsinki 1996
Parties:
Sponsor Organisation; Manufacturing Organisation; Importing Organisation
Geographic scope:
Great Britain
Intended use:
Clinical trials
Term:
Up to five years from final signature
Review frequency:
Every five years
Annexes:
Drug products and services; Responsibilities of each Party; Key Contact Persons; List of Subcontractors; Technical Agreement Approval; Version History
Providing organisation:
The Newcastle upon Tyne Hospitals NHS Foundation Trust Quality Assurance Pharmacy Team
Source type:
Contractual regulatory document governing quality responsibilities in clinical research supply chains
Year:
2026
Country:
Pakistan
Authority:
Drug Regulatory Authority of Pakistan
Document Type:
Application Form
Subject:
Registration and Renewal of Medical Devices
Applicable Classes:
B, C, D
Submission Requirements:
Enclosures, Certificates, Softcopy on USB/CD
Responsible Person:
Proprietor, Chief Executive, Managing Director or Authorized Officer
Legal Reference:
Drug Regulatory Authority of Pakistan Act, 2012
Intended Use:
Local Manufacture of Medical Devices
Year:
2022
Region / City:
Florida
Topic:
Criminal law, controlled substances
Document type:
Legal instruction
Agency / Institution:
Florida State
Author:
Florida Legislature
Target audience:
Legal professionals, judges
Period of validity:
Ongoing
Approval date:
15 December 2021
Date of amendments:
21 December 2022
Organization:
International Narcotics Control Board
Related instrument:
Single Convention on Narcotic Drugs of 1961
Note:
Related instrument
1972 Protocol amending the Single Convention on Narcotic Drugs of 1961
Document type:
Statistical reporting form
Scope:
Production, manufacture, consumption, utilization, stocks and seizures of narcotic drugs
Addressee:
Governments of countries or territories
Reporting deadline:
Not later than 30 June of the year following the reporting year
Reporting period:
Calendar year
Submission address:
Vienna International Centre, P.O. Box 500, 1400 Vienna, Austria
Contact email:
[email protected]
Website:
http://www.incb.org/
Structure:
Part I (Manufacture, consumption, utilization and stocks); Part II (Utilization for manufacture of other substances); Part III (Licit cultivation and production of plant-based narcotic materials); Part IV (Seizures of narcotic drugs and pharmaceutical products)
Measurement units:
Kilograms and grams; for certain substances grams and milligrams
Reference document:
List of Narcotic Drugs under International Control (“Yellow List”)
Year:
2026
Region / City:
Pretoria
Subject:
Cannabis cultivation, manufacturing, and importation for medicinal purposes
Document Type:
Application Form
Organization / Institution:
South African Health Products Regulatory Authority (SAHPRA)
Author:
South African Health Products Regulatory Authority (SAHPRA)
Target Audience:
Applicants seeking licenses for cannabis cultivation, manufacturing, or importation
Effective Period:
5 years
Approval Date:
[Not specified]
Date of Modifications:
[Not specified]
Note:
Year
Topic:
Ayurvedic, Siddha, and Unani drugs testing
Document type:
Application form
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Year:
2016
Region / City:
United States
Topic:
Pharmacy Information Management
Document Type:
Technical Requirement
Organization / Institution:
Veterans Health Administration (VHA)
Author:
Veterans Health Administration
Target Audience:
Vendors, Pharmaceutical Suppliers, IT Developers
Period of Validity:
From January 18, 2017
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2019
Region / City:
United States
Topic:
Information Technology, Veterans Affairs, Healthcare
Document Type:
Performance Work Statement
Agency / Institution:
Department of Veterans Affairs, Office of Information & Technology
Author:
Not specified
Target Audience:
Contractors, VA staff, IT professionals
Period of Effectiveness:
June 27, 2019, onwards
Approval Date:
June 27, 2019
Amendments Date:
Not specified
Year:
2025
Region / City:
Louisiana
Topic:
Alcohol and Drug Survey
Document Type:
Guidelines
Organization / Institution:
Louisiana Board of Regents
Author:
Dr. Allison Smith
Target Audience:
IRB administrators, researchers, university staff
Period of Validity:
2025
Approval Date:
October 4, 2024
Amendment Date:
November 15, 2024
Note:
Year
Subject:
Emergency Use Treatment
Document Type:
Informed Consent Form
Year:
2025
Jurisdiction:
Washington State
Topic:
Drug supply chain security and pharmacy regulatory compliance
Document type:
Self-inspection worksheet
Issuing body:
Washington State Pharmacy Quality Assurance Commission
Governing law:
Drug Supply Chain Security Act (DSCSA); RCW 18.64.026; WAC 246-945
Applicable entities:
Drug manufacturers; wholesale distributors; dispensers
Regulatory scope:
State and federal pharmacy law
Compliance status:
Optional addendum with mandatory DSCSA compliance
Intended role:
Responsible pharmacy manager or equivalent manager
Retention requirement:
Kept on file; not submitted to the commission
Source type:
Government regulatory document