№ lp_1_18917
File format: docx
Character count: 4357
File size: 47 KB
This document provides instructions for filling out a short form used to update product packaging and related GTIN and DSCSA exemption information for pharmaceutical and medical device products.
Note:
Year
Theme:
Pharmaceutical products, Medical devices
Document type:
Instructions, Form
Organization / Institution:
HDA
Target audience:
Distributors, Manufacturers, Supply chain professionals
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Year:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021
Year:
2024
Region / City:
N/A
Subject:
Pharmaceutical Products, Medical Devices, Distribution
Document Type:
Instructional Form
Institution:
Healthcare Distribution Alliance (HDA)
Author:
N/A
Target Audience:
Manufacturers, Repackagers, Distributors
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
2024
Year:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021
Year:
2024
Region / City:
N/A
Subject:
Pharmaceutical Products, Medical Devices, Distribution
Document Type:
Instructional Form
Institution:
Healthcare Distribution Alliance (HDA)
Author:
N/A
Target Audience:
Manufacturers, Repackagers, Distributors
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
2024
Year:
2025
Region / City:
Dorset, BCP Council
Theme:
Pharmaceutical Services, Health Needs Assessment
Document Type:
Draft Report
Organization:
Public Health Dorset
Author:
Jane Horne, Lee Robertson, Wilson Otitonaiye, Rohan Mongru, Fiona Arnold, Louise Bate
Target Audience:
Health professionals, policymakers, local authorities
Period of Validity:
2025-2028
Approval Date:
Draft version, ongoing review
Date of Last Update:
04/06/2025
Context:
This document provides a comprehensive pharmaceutical needs assessment for the Dorset area, focusing on the supply, demand, and gaps in pharmaceutical services over the period 2025-2028.
Year:
2014
Region / City:
Global
Topic:
Pharmaceutical Product Prequalification
Document Type:
Guideline
Organization / Institution:
World Health Organization (WHO)
Author:
World Health Organization
Target Audience:
Pharmaceutical manufacturers, regulatory bodies
Effective Period:
Not specified
Approval Date:
2014
Modification Date:
Not specified
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Year:
2023
Region / City:
United Kingdom
Topic:
Pharmaceutical guidance
Document type:
Consultation response
Organization:
Royal Pharmaceutical Society
Author:
Royal Pharmaceutical Society
Target audience:
Pharmacy professionals, regulatory bodies, pharmacy service owners
Action period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Document type:
Regulatory template appendix
Subject:
Quality information summary for finished pharmaceutical products and vaccines
Procedure:
Reference SRA collaborative procedure
Regulatory framework:
WHO Guidelines on submission of documentation for prequalification
Issuing organization:
World Health Organization
Series:
WHO Technical Report Series
Series number:
No. 1010
Year:
2018
Scope:
Pharmaceutical products and vaccines approved by stringent regulatory authorities
Intended use:
National registration under the SRA collaborative procedure
Confidentiality status:
Includes confidential quality information
Approval basis:
Information as approved by the reference SRA
Change management:
Revision required upon approved variations affecting QIS-SRA (crp)
Organization:
World Health Organization; South African Health Products Regulatory Authority
Document type:
Regulatory guideline
Subject area:
Pharmaceutical quality documentation
Scope:
Multisource (generic) finished pharmaceutical products and active pharmaceutical ingredients
Applicable products:
Human medicines; biologics; veterinary medicines
Regulatory references:
WHO TRS 970 Annex 6; VICH guidelines; European Pharmacopoeia; USP; BP
Geographical applicability:
International; South Africa
Related regulatory procedures:
API Prequalification; CEP; APIMF; product dossier submission
Content focus:
Quality data requirements; labelling and product information; drug substance characterization
Intended users:
Marketing authorization applicants; regulatory assessors
Year:
2021
Region / City:
United States
Topic:
Pharmaceutical and Medical Device Product Information
Document Type:
Instructional Form
Organization / Institution:
Health Distribution Alliance (HDA)
Author:
Health Distribution Alliance
Target Audience:
Pharmaceutical distributors, medical device manufacturers, suppliers
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
2021
Year:
2023
Region / City:
Falkirk
Theme:
Health & Social Care, Pharmacy, Medication Management
Document Type:
Policy
Organization:
Falkirk Health & Social Care Partnership
Author:
Not specified
Target Audience:
Community pharmacies, care at home providers, healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / city:
Great Britain
Topic:
Remote hearings, Pharmacy, Patient safety
Document type:
Response to consultation
Organization:
Royal Pharmaceutical Society
Author:
Jonathan Lloyd Jones
Target audience:
General Pharmaceutical Council, Pharmacy professionals, Stakeholders
Validity period:
N/A
Approval date:
February 7, 2022
Amendment date:
N/A
Year:
2025
Region / City:
Australia
Topic:
Pharmaceutical benefits, chemotherapy, PBS
Document Type:
FAQ
Organization:
Pharmaceutical Benefits Scheme
Author:
Pharmaceutical Benefits Advisory Committee (PBAC)
Target Audience:
Healthcare providers, prescribers, patients
Effective Period:
From December 1, 2024
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
FAQ document providing detailed information on the changes in PBS listing for Opdualag and Vyxeos under the EFC Program, including prescription and claiming details.
Year:
2023
Country:
United Kingdom
Organisation:
Royal Pharmaceutical Society
Document type:
Evidence submission
Topic:
Inclusion and diversity in pharmacy services
Population focus:
LGBTQ+ communities
Methodology:
Mixed-methods survey and literature review
Sample size:
620 survey respondents
Data sources:
RPS I&D Programme evaluation survey; published academic studies
Status:
Unpublished internal survey with referenced published research
Scope:
Community and pharmacy professional services
Context:
Evidence submission to an LGBT+ health review drawing on an internal inclusion and diversity survey and recent pharmacy-focused research to describe experiences, barriers, and attitudes related to LGBTQ+ access to pharmacy services in the UK.
Year:
2026
Region / City:
United Kingdom
Topic:
Genomics Education, Pharmacogenomics, NHS Workforce Development
Document Type:
Written Evidence Submission
Organization / Institution:
Royal Pharmaceutical Society
Author:
Royal Pharmaceutical Society
Target Audience:
NHS professionals, educational providers, healthcare policy makers
Period of Action:
2026-2030
Approval Date:
2026
Date of Amendments:
N/A
Note:
Year
Topic:
Pharmaceutical product certification
Document Type:
Certificate
Authority / Organization:
Health Products Regulatory Authority (HPRA)
Target Audience:
Regulatory authorities, pharmaceutical companies
Note:
Year
Theme:
Pharmaceutical Products
Document Type:
Certificate
Organization / Institution:
Federal Agency for Medicines and Health Products (FAMHP)
Author:
Ethel Mertens
Target Audience:
Regulatory authorities, pharmaceutical manufacturers
Year:
2024
Region / City:
N/A
Subject:
Pharmaceutical Products, Medical Devices, Distribution
Document Type:
Instructional Form
Institution:
Healthcare Distribution Alliance (HDA)
Author:
N/A
Target Audience:
Manufacturers, Repackagers, Distributors
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
2024