№ lp_1_2_06901
File format: docx
Character count: 2978
File size: 374 KB
Note:
Year
Contextual description:
A regulatory submission form for post-marketing safety updates on human medicines, including details of the product, safety variations, and exposure data for Switzerland and worldwide.
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Year:
2025
Region / city:
European Union
Topic:
Pharmacovigilance, PSUR Follow-Up
Document Type:
Report
Organ / institution:
CMDh
Author:
Lead Member State
Target Audience:
Health authorities, pharmaceutical companies, regulatory bodies
Period of validity:
February 2025 onwards
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2015
Type of document:
Assessment report template
Subject:
Pharmacovigilance, Periodic Safety Update Reports (PSUR)
Organization:
European Medicines Agency (EMA)
Target audience:
Lead Member States, MAHs, PRAC members
Procedure number:
Not specified
Data lock point:
Not specified
Status:
Guidance and procedural template
References:
GVP Module V, VII, VIII; Variations Classification guideline Commission Regulation 1234/2008; HMA/EMEA recommendations EMEA/743133/2009
Year:
2022
Note:
Region / City
Theme:
Post-market surveillance, safety reporting
Document Type:
Template
Author:
MDCG
Target Audience:
Manufacturers of medical devices
Year:
2016
Note:
Region / city
Subject:
Post-audit functionality, Notifications, API
Document Type:
Release Notes
Organization:
EMA
Target Audience:
NCA users, MAHs, EMA
Date of Changes:
06 Jan 16
Year:
2026
Organization:
European Medicines Agency (EMA)
Document Type:
Account Request Form
Target Audience:
NCA Staff
Purpose:
Request access to PSUR Repository
Data Protection Compliance:
Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EC) No 45/2001
Contact Email:
[email protected]
Instructions:
Fill personal and work information, specify account use and user type, agree to ECD policy
Year:
2023
Region / city:
Australia
Subject:
Pharmaceutical compounding guidelines
Document Type:
Guideline
Organization / Institution:
Pharmacy Board of Australia
Author:
Pharmacy Board of Australia
Target Audience:
Registered pharmacists, education providers, employers
Period of validity:
Indefinite
Approval Date:
Not specified
Date of amendments:
Not specified
Year:
2016
Region / City:
Australia
Topic:
Pharmacy, Medicine Compounding
Document Type:
Consultation Response
Organization:
Pharmaceutical Society of Australia
Author:
Dr Lance Emerson, Chief Executive Officer
Target Audience:
Pharmacists, Pharmacy Regulators
Period of Validity:
Indefinite
Approval Date:
1 February 2016
Date of Amendments:
None
Contextual Description:
Document is a public consultation response discussing terminology issues and proposed updates regarding compounded parenteral medicines, primarily aimed at Australian pharmacists.
Organisation:
Canberra Health Services
Document type:
Guideline
Reference number:
CHS25/225
Jurisdiction:
Australian Capital Territory
Healthcare setting:
Public health services
Subject area:
Medication management
Professional scope:
Nursing and midwifery practice
Approved by:
Drug and Therapeutics Committee
Target professionals:
Registered nurses and registered midwives
Patient groups:
Adults, children 12 years or older, and selected medicines for children under 12 years
Exclusions:
Neonates, Special Care Nursery patients, Neonatal Intensive Care Unit patients
Regulatory framework:
Australian medicines scheduling (Schedules 2, 3, 4, and 8)
Content components:
Governance, safe use, documentation, approved medicine lists
Year:
2023
Region / city:
European Union
Topic:
Pharmaceutical technology development
Document type:
Briefing document
Organization:
European Medicines Agency
Author:
Not specified
Target audience:
Pharmaceutical experts, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
This document is a briefing source for discussing pharmaceutical technology and regulatory aspects at a QIG 1:
1 meeting.
Year:
2023
Country:
Australia
Topic:
Opioid dependence treatment
Document type:
Information overview
Program:
ODT Community Pharmacy Program
Administering body:
Pharmacy Programs Administrator
Related scheme:
Pharmaceutical Benefits Scheme
Legislative framework:
National Health (Highly specialised drugs program) Special Arrangement 2021
Target audience:
Community pharmacists and hospital pharmacists
Effective date:
1 July 2023
Funding period:
2023–24 to 2026–27
Medicines covered:
Methadone, buprenorphine, buprenorphine with naloxone
Regulatory classification:
Schedule 8 controlled drugs
Source type:
Government health program guidance
Document type:
Q&A guidance
Jurisdiction:
Japan
Subject:
Import and shipment of medicines and medical devices
Issuing authority:
Ministry of Health, Labour and Welfare
Intended users:
Individuals importing or sending medicines for personal use
Scope:
Prescription medicines, injections, syringes, and medical devices
Import purpose:
Personal use
Regulatory framework:
Pharmaceutical and Medical Device regulations
Application system:
Online Import Confirmation system
Related forms:
Import Confirmation Application Form (Form 12); Explanation of Pharmaceutical Product (Form 13)
Year:
2024
Region / city:
Denmark
Topic:
Medicine, Health Economics
Document type:
Template
Organization / institution:
Danish Medicines Council
Author:
Danish Medicines Council
Target audience:
Pharmaceutical companies
Period of validity:
Ongoing
Approval date:
10 September 2024
Date of changes:
1 April 2025
Version:
2.5
Year:
2021
Region / city:
Victoria, Australia
Theme:
Pharmacist regulations
Document type:
Legislative guideline
Agency / institution:
Medicines and Poisons Regulation (MPR)
Author:
Medicines and Poisons Regulation (MPR)
Target audience:
Health practitioners, pharmacists
Period of validity:
Ongoing
Approval date:
2017
Date of amendments:
2021
Context:
This document provides guidelines for pharmacists regarding the dispensing, administration, and supply of Schedule 4 and 8 medicines in Victoria, Australia, as outlined in the Drugs Poisons and Controlled Substances Act 1981 and related regulations.
Year:
2020
Region / city:
UK
Theme:
Medicines Information
Document type:
List
Organization / institution:
NHS
Author:
UKMi
Target audience:
NHS Medicines Information Services
Period of validity:
Ongoing, updated quarterly
Approval date:
November 2020
Date of changes:
May 2020
Note:
Year
Subject:
Medicine Formularies, Health Policy
Document Type:
Form, Application
Institution:
Ministry of Health
Author:
Applicant (Consultant, Specialist, Medical Officer, Pharmacist)
Target Audience:
Healthcare Professionals, Drug and Therapeutic Committee
Context:
Form used to propose the inclusion of a medicine or indication from the Ministry of Health Medicines Formulary into an institution’s Medicines Formulary for approval by the institution’s Drug and Therapeutic Committee.
Year:
Not specified
Region / City:
Malaysia
Topic:
Pharmaceutical registration and formulary listing
Document Type:
Application Form
Organization / Institution:
Ministry of Health Malaysia
Author:
Not specified
Target Audience:
Pharmaceutical companies, regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Health, Pharmaceuticals
Document Type:
Informational Resource
Organization / Institution:
U.S. Food and Drug Administration
Target Audience:
Consumers, Healthcare Providers, Information Professionals, Researchers
Year:
2018
Region / City:
Wellington, New Zealand
Topic:
Medicine administration
Document type:
Guideline
Organization / Institution:
New Zealand Nurses Organisation
Author:
New Zealand Nurses Organisation
Target audience:
Nurses, midwives
Period of validity:
Not specified
Approval date:
2018
Date of changes:
Not specified
ISBN:
978-1-877461-66-8