№ files_lp_3_process_7_066888
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Character count: 2599
File size: 51 KB
Government fact sheet outlining legislative changes effective 1 February 2021 requiring inclusion of active ingredients on PBS and RPBS prescriptions, detailing exceptions, prescriber obligations, software requirements, and sources of further information.
Year:
2021
Country:
Australia
Subject:
Active Ingredient Prescribing (AIP)
Document Type:
Fact Sheet
Related Programs:
Pharmaceutical Benefits Scheme (PBS); Repatriation Pharmaceutical Benefits Scheme (RPBS)
Issuing Authority:
Australian Government Department of Health
Effective Date:
1 February 2021
Target Audience:
Prescribers, pharmacists, consumers
Scope:
Hospital and community settings
Regulatory Context:
Legislative requirements for PBS and RPBS prescriptions
Contact:
[email protected]
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Region / city:
United Kingdom
Theme:
Organic food certification
Document type:
Form
Organization / institution:
Soil Association
Author:
Soil Association
Target audience:
Companies submitting products for certification
Effective period:
From September 2025
Approval date:
Not specified
Amendment date:
March 2024
Year:
2024
Region / City:
United Kingdom
Subject:
Multi-ingredient product submission form
Document Type:
Form
Organization / Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies submitting multi-ingredient products
Effective Period:
From September 2025
Approval Date:
Not specified
Amendment Date:
March 2024
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / city:
United Kingdom
Topic:
Food & Drink Certification
Document Type:
Form
Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies sourcing multi-ingredient food products
Period of Validity:
Until September 2025
Approval Date:
March 2024
Date of Changes:
September 2025
Year:
2022
Region / City:
Rwanda
Subject:
Pharmaceutical manufacturing, GMP inspection
Document Type:
Form
Organ / Institution:
Rwanda Food and Drugs Authority
Author:
N/A
Target Audience:
Pharmaceutical manufacturers
Period of validity:
20 June 2022 - 10 October 2025
Approval Date:
20 June 2022
Revision Date:
03 October 2022
Effective Date:
11 October 2022
Review Due Date:
10 October 2025
Year:
2020
Region / City:
Australia
Topic:
Health software, Active ingredient prescribing
Document Type:
Vendor Resource Document
Organization:
Medical Software Industry Association (MSIA)
Author:
MSIA in collaboration with The Australian Government Department of Health
Target Audience:
Prescribing software developers
Effective Period:
2020
Approval Date:
1 December 2020
Amendment Dates:
23/07/2019, 07/08/2019, 15/08/2019, 22/08/2019, 28/08/2019, 10/09/2019, 24/09/2019, 28/10/2019, 31/10/2019, 7/11/2019, 28/11/2019, 5/12/2019, 29/01/2020, 12/02/2020, 24/02/2020, 27/05/2020, 13/08/2020, 26/08/2020, 5/11/2020, 1/12/2020
Note:
Context Description
Note:
Year
Document Type:
Terms and Conditions
Organization:
Innovative Education Ltd.
Target Audience:
Schools
Context:
Terms and conditions document outlining the subscription, delivery, and service details for Classroom Kitchen Ingredient Delivery Service.
Year:
2026
Document type:
Application form
Subject:
Prequalification of Active Pharmaceutical Ingredient (API)
Organization:
World Health Organization Prequalification Team (PQTm)
Applicant:
[Company name from application]
Contact person:
[Name and position from application]
API manufacturer:
[Name and address from application]
API intermediate manufacturer(s):
[Names and addresses from application]
Site Master File (SMF) included:
Yes / No (depending on submission)
GMP compliance evidence:
Included / Requested inspection
Relevant standards:
ICHQ7, ICHQ3D, Pharmacopoeial standards
Other regulatory agencies involved:
EDQM, US FDA, other authorities if listed
Note:
Year
Theme:
Pharmaceutical
Document Type:
Application form
Organization / institution:
World Health Organization (WHO)
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Context description:
A form for submitting an application to WHO for API prequalification, including details on manufacturing sites, GMP compliance, and nitrosamine risk assessment.
Year:
2026
Region / City:
Not specified
Topic:
Health / Antioxidants
Document Type:
Product Information
Organization / Institution:
E. EXCEL
Author:
Not specified
Target Audience:
Health-conscious individuals
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2025
Region / City:
Arlington, VA
Document Type:
Press Release
Organization:
PBS KIDS
Author:
Genie Deez, Thy Than
Target Audience:
Parents, Preschoolers
Period of Validity:
Fall 2025
Approval Date:
January 22, 2025
Funding Source:
Corporation for Public Broadcasting, U.S. Department of Education
Year:
2025
Region / City:
Cincinnati, OH
Subject:
Documentary
Document Type:
Film
Organization:
PBS
Author:
Yemi Oyediran
Target Audience:
General Public
Effective Date:
October 10, 2025
Date of Approval:
September 18, 2025
Description:
A documentary film about the history and cultural impact of King Records, shedding light on its groundbreaking role in American music.
Year:
2025
Region / city:
Australia
Subject:
Oncology, Pharmaceutical Submission
Document Type:
Pharmaceutical Benefits Scheme (PBS) Submission
Organ / Institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
JANSSEN-CILAG PTY LTD
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Ongoing
Approval Date:
Pending
Date of modifications:
N/A
Year:
Not specified
Region / City:
Not specified
Theme:
Reproduction, Biology
Document Type:
Worksheet
Author:
Not specified
Target Audience:
Students
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2000
Region / city:
United States
Theme:
Elections, History, Government
Document type:
Educational Lesson Plan
Author:
Stephanie Schragger
Target audience:
Students, Grades 7-12
Period of validity:
Not specified
Approval date:
Not specified
Date of last modification:
Not specified
Context:
Educational resource aimed at teaching about contested elections in U.S. history, specifically the 2000 and 2020 elections.
Year:
2025
Region / City:
New York City
Topic:
Documentary, Politics, History, Vietnam War
Document Type:
Documentary Film
Organization:
PBS, American Experience
Author:
Marc Levin, Daphne Pinkerson
Target Audience:
General Public, History and Politics Enthusiasts
Period of Action:
May 8, 1970
Approval Date:
N/A
Date of Changes:
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:
2024
Region / city:
Australia
Topic:
Biosimilars, pharmaceutical regulation
Document type:
Submission report
Organ / institution:
Australian Government, Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Sandoz Pty Ltd
Target audience:
Regulatory bodies, pharmaceutical industry professionals
Period of validity:
2024–2025
Approval date:
15 May 2024
Date of changes:
March 2024
Medicine:
Aciclovir eye ointment 3% (3 mg/g), 4.5 g
Brand name:
Xorox
Sponsor:
Clinect Pty Ltd
ARTG listing date:
6 November 2020
Country:
Australia
Indication:
Herpes simplex keratitis
Regulatory authority:
Therapeutic Goods Administration
Reimbursement scheme:
Pharmaceutical Benefits Scheme
PBAC status:
Not previously considered prior to this submission
Comparator products:
AciVision, Zovirax
Submission type:
Minor submission
Listing type requested:
Restricted benefit, General Schedule
Prescriber types:
Medical practitioners, nurse practitioners, optometrists
Legal framework:
Therapeutic Goods Act 1989, Section 19A
Period discussed:
2014–2021
Source type:
Public Summary Document
Drug name:
Apremilast
Brand name:
Otezla
Dosage form:
Tablet
Strength:
30 mg
Pack composition:
4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor:
Amgen Australia Pty Ltd
Regulatory status:
TGA registered
TGA registration date:
19 March 2015
Indication:
Severe plaque psoriasis
Previous indication:
Psoriatic arthritis and moderate to severe plaque psoriasis
Application type:
Minor resubmission
Requested listing:
PBS General Schedule, Authority Required (STREAMLINED)
Comparator:
Cyclosporin
Clinical population:
Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome:
PASI-75 at 16 weeks
Clinical claim:
Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission history period:
2015–2018
Geographic scope:
Australia
Source type:
Public summary document excerpt