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September Newsletter
30Sep 2024
News admin Comments: 0

September Newsletter 2024

We look forward to sharing the latest updates and insights in our September Newsletter 2024. What’s inside in September Newsletter 2024? 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for September 2024 Please read below for more information. September Newsletter 2024...
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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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General Information September 26, 2024 admin Comments: 0

Medical Device Classification in Australia

In Australia, medical devices are classified into four risk-based categories: Class I (low risk), Class IIa, Class IIb, and Class III (high risk). The Therapeutic Goods Administration (TGA) oversees classification and regulatory approval. Higher-risk devices require more stringent evaluation, ensuring safety and efficacy before entering the market. Download the below PDF to get more detailed information about Different Categories of Medical Devices in Australia....
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UK Cosmetics Requirements
26Sep 2024
Cosmetics, Registrations, UK admin Comments: 0

UK Cosmetics Requirements and Registration Process

The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements & Registration Process This is an overview of the requirements and the registration process for cosmetics in the UK. 1. Regulatory Authority The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Departmen...
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Windsor Framework
23Sep 2024
EU, General Information admin Comments: 0

What Manufacturers and Wholesalers Should Know About MHRA Compliance and the Windsor Framework?

This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines. Key Responsibilities for Marketing Authorization Holders (MAHs) Marketing Authorization Holders must communicate any chan...
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Human Medicines
20Sep 2024
General Information, UK admin Comments: 0

UK-Wide Licensing for Human Medicines

1. Overview  This guideline gives information on how the Windsor Framework will be implemented in the UK regarding the licensing of medications for human use.   The Medicines and Healthcare Products Regulatory Agency (MHRA) will license medications throughout the United Kingdom starting on January 1, 2025.   The Human Medicines Regulations 2012 legislation, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, and other pertinent...
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August Newsletter 2024 – Korean
10Sep 2024
News admin Comments: 0

August Newsletter 2024 – Korean

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Korean What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Korean...
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august newsletter
09Sep 2024
News admin Comments: 0

August Newsletter 2024 – Simplified Chinese

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Simplified Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Simplified Chinese...
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august newsletter traditional chinese
09Sep 2024
News admin Comments: 0

August Newsletter 2024 – Traditional Chinese

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Traditional Chinese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Traditional Chinese...
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august newsletter
04Sep 2024
News admin Comments: 0

August Newsletter 2024 – Japanese

We look forward to sharing the latest updates and insights in our August Newsletter 2024 – Japanese. What’s inside!! 1. The latest information on medical device regulations and compliance 2. Cosmetics safety standards and industry trends 3. List of Updated ISO Standards for August 2024 Please read below for more information. August Newsletter Japanese...
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