№ lp_1_2_04201
File format: docx
Character count: 20794
File size: 191 KB
The document is a form for the new authorisation of human medicinal products for use in Switzerland.
Year:
2025
Region / city:
Switzerland
Theme:
Medicinal product authorisation
Document type:
Regulatory submission form
Organisation / institution:
Swissmedic
Author:
Swissmedic
Target audience:
Pharmaceutical companies
Period of validity:
From 01.10.2025
Approval date:
Pending
Amendment date:
N/A
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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
Year:
2016
Region / city:
EU
Theme:
Pharmaceutical Regulation
Document Type:
Guideline
Organization:
EFPIA
Author:
Sini Eskola
Target audience:
Regulatory authorities, pharmaceutical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Document Type:
Quality Technical Agreement
Year:
2022
Region / City:
European Union
Theme:
Orphan medicinal products, market exclusivity
Document type:
Template
Organization:
European Medicines Agency
Author:
CMDh
Target Audience:
Applicants for marketing authorization of orphan medicinal products
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
July 2022
Note:
Region / City
Document Type:
Validation Checklist
Contextual description:
A validation checklist for medicinal product applications within the Decentralized Procedure (DCP) process.
Year:
2024
Region / city:
EU
Subject:
Health Technology Assessment
Document type:
Annex
Organization:
HTA CG
Author:
European Commission
Target audience:
Health Technology Assessment bodies, regulatory bodies
Effective period:
October 2024
Approval date:
28 November 2024
Modification date:
None
Year:
2025
Region / City:
Switzerland
Topic:
Medicinal Product Authorisation
Document Type:
Application Form
Institution:
Swissmedic
Author:
Not specified
Target Audience:
Regulatory authorities, Pharmaceutical companies
Period of validity:
From 01.01.2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Global
Subject:
Clinical trials, Teletrial Model, Investigational Medicinal Product
Document Type:
Standard Operating Procedure (SOP)
Institution:
Teletrial Primary Site Pharmacy
Author:
Not specified
Target Audience:
Clinical trial staff, Teletrial site personnel
Period of validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2016
Region / city:
Europe
Topic:
Good Manufacturing Practice for Advanced Therapy Medicinal Products
Document type:
Consultation response
Organization / institution:
EBE/EFPIA
Author:
EBE/EFPIA
Target audience:
Pharmaceutical industry, Regulatory authorities
Period of validity:
Indefinite
Approval date:
28-Jun-2016
Modification date:
N/A
Year:
2024
Region / city:
Europe
Theme:
Health Technology Assessment, Medicinal Products
Document type:
Template
Organization:
European Medicines Agency (EMA), HTACG
Author:
Not specified
Target audience:
Health Technology Developers (HTD), European regulatory bodies
Period of validity:
Not specified
Date of approval:
28 November 2024
Date of revisions:
Not specified
Year:
2019
Region / city:
Ireland
Topic:
Investment company, liquidation
Document type:
Consultation Paper
Institution:
Central Bank of Ireland
Author:
Central Bank of Ireland
Target audience:
Investment companies, financial institutions
Period of validity:
Indefinite until revocation
Date of approval:
July 2019
Date of amendments:
N/A
Purpose:
Outline of the appeal process for reviewable decisions
Jurisdiction:
South Australia
Scheme:
South Australian Restrictive Practices Authorisation scheme
Legal basis:
Disability Inclusion Act 2018 (Part 6A, ss. 23L, 23N, 23O, 23P, 23Y, 23Z)
Regulations:
Disability Inclusion (Restrictive Practices – NDIS) Regulations 2021, s. 14
Document type:
Administrative procedure
Responsible unit:
Restrictive Practices Unit
Decision-makers:
Authorised Program Officer; Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Scope:
Appeals of reviewable decisions relating to restrictive practices
Target audience:
RPU staff, people with disability, family members, NDIS service providers
Appeal timeframe:
30 days from original decision, with possible extension
Review bodies:
Senior Authorising Officer; South Australian Civil and Administrative Tribunal
Source type:
Government administrative procedure governing appeals and reviews of restrictive practice authorisation decisions within the South Australian NDIS regulatory framework.
Note:
Year
Theme:
Special Religious Education, Child Protection
Document Type:
Authorisation Letter
Organisation / Institution:
Department of Education
Target Audience:
Approved Providers, School Coordinators
Year:
2024
Region / City:
Malta
Topic:
ICT Third-Party Service Providers
Document Type:
Regulatory Form
Organization / Institution:
Malta Financial Services Authority (MFSA)
Author:
Malta Financial Services Authority (MFSA)
Target Audience:
Financial entities applying for authorisation from MFSA
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2003
Jurisdiction:
Victoria, Australia
Document type:
Application form / Regulatory form
Regulation:
Cemeteries and Crematoria Regulations 2025, Regulation 30
Issuing authority:
Victorian Government
Related legislation:
Births, Deaths and Marriages Registration Act 1996; Coroners Act 2008; Privacy and Data Protection Act 2014; Public Records Act 1973
Purpose:
Authorisation of cremation for deceased persons
Attachments required:
Notice of death, Certificate of registered medical practitioner, Coroner’s order, notice of still-birth (if applicable)
Penalties:
False statements punishable under section 132 of the Cemeteries and Crematoria Act 2003
Applicant type:
Natural person or corporate body
Cremation details:
Name of crematorium, date of cremation, place and type of interment
Contact information:
Applicant and funeral director details, including address, telephone, and email