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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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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

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 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 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 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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August Newsletter 2024

We look forward to sharing the latest updates and insights in our August Newsletter 2024. What’s inside in August 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 August 2024 Please read below for more information. August Newsletter 2024...
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Mpox: Origin, Global Impact, Testing, and Solutions

Mpox, formerly known as monkeypox, is a viral zoonotic disease that has rapidly emerged as a global health concern. The mpox virus, a member of the Orthopoxvirus genus, was first identified in humans in the Democratic Republic of the Congo (DRC) in 1970. For decades, the disease was mostly confined to Central and West Africa, where it remained endemic. However, beginning in the spring of 2022, mpox began spreading to countries outside of Africa, regions that had rarely seen cases in the past. Si...
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Whitepaper: The Future of the Global In-Vitro Diagnostics (IVD) Market: Trends, Challenges, and Opportunities

This white paper explores the global In-Vitro Diagnostics (IVD) market, focusing on the next five years. It covers the most sold devices, countries with high procurement, complexities faced by manufacturers, market evolution, and the impact of regulations. The insights provided are based on current market trends and data. Topics Covered in this Whitepaper 1. Introduction 2. Overview of the Global In Vitro Diagnostics Market 3. Complexities Faced by Manufacturers 4. Evolution of IVD Market 5. Imp...
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July Newsletter 2024 – Japanese

2024 年 7 月のニュースレターで最新の更新情報と洞察を共有できることを楽しみにしています。中には何があるんだ! !1. 医療機器の法規制・コンプライアンスに関する最新情報2. 化粧品の安全基準と業界動向3. 2024 年 7 月の更新された ISO 規格のリスト詳細については、以下をお読みください。July Newsletter Japanese...
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