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Clinical Evaluation Plan

Overcoming the stringent European Union Medical Device Regulation (EU MDR) can be challenging. At EU MDR Templates, we provide expertly crafted EU MDR documentation plan's template designed to simplify your regulatory compliance process. Enquiry Now View Brochure  ...
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KIMES Busan Medical & Hospital Equipment Show

The KIMES Busan Medical & Hospital Equipment Show is a premier event in South Korea’s medical industry, showcasing the latest advancements in medical technology, hospital equipment, and healthcare solutions. Held annually in Busan, KIMES Busan attracts healthcare professionals, medical equipment manufacturers, and industry leaders from around the world, creating an ideal platform for networking, discovering new technologies, and expanding knowledge in the healthcare sector. Key Highlights...
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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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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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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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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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Cosmetic Regulatory Requirements in Finland

Cosmetic Regulatory Requirements in Finland complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements. Finnish Safety and Chemicals Agency (Tukes) In Finland, the regulatory authority responsible for overseeing cosmetic products is the Finnish Safety and Chemicals Agency (Tukes). Tukes ensures that cosmetic products placed on the Finnish market comply with the EU regulations and meet safety standards. Language Requirements According to Finnish regula...
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Cosmetic Regulatory Requirements in Luxembourg

Cosmetic Regulatory Requirements in Luxembourg complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements specific to cosmetics. The regulation sets out stringent requirements to ensure the safety of cosmetic products before they are placed on the market. Luxembourg Cosmetic Regulatory Requirements Ministry of Health (Ministère de la Santé) The regulatory authority overseeing cosmetic products in Luxembourg is the Ministry of Health (Ministère de l...
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Cosmetic Regulatory Requirements in Sweden

In Sweden, cosmetic products are regulated primarily under the framework of the European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetic products across the EU member states, including Sweden. Medical Products Agency (MPA) In Sweden, the Medical Products Agency (MPA) or Läkemedelsverket is responsible for overseeing the regulation of cosmetic products. The MPA ensures that cosmetic products pla...
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