In the European Union (EU), cosmetic products play a significant role in the beauty and personal care industry. To ensure the safety and quality of these products, the EU has put in place stringent regulations, including specific guidelines for cosmetic packaging. Cosmetic manufacturers and suppliers looking to market their products in the EU must understand and comply with these requirements. In this blog, we shall explore the fundamental aspects of cosmetic packaging regulations in the EU.
An Overview of Document Registration for Medical Devices in Turkey
In Turkey, document registration is a crucial step in obtaining Regulatory approval for medical devices. The Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK), or the Turkish Medicines and Medical Devices Agency, oversees this process, ensuring strict adherence to the country’s regulations and standards. Manufacturers and importers must undergo a comprehensive evaluation prior to introducing their devices in the Turkish market.
In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
The European Union (EU) has implemented strict regulations to ensure biocidal products’ safe and effective use. Biocides are crucial in controlling harmful organisms such as bacteria, viruses, and pests and are widely used in various sectors, including healthcare, agriculture, and household products. Compliance with EU Biocidal Product Regulation (BPR) ensures market access and consumer protection. To navigate the complexities of BPR compliance within the EU, consider partnering with a Regulatory expert.
The European Regulatory landscape presents a myriad of challenges and opportunities for pharmaceutical companies seeking to bring their products to the market. Navigating the complexities of the diverse Regulatory frameworks of the region, the varied linguistic requirements, and the ever-evolving guidelines requires a well-executed staffing strategy.
In this blog, we shall explore the key considerations and effective strategies for optimizing Regulatory affairs staffing in Europe, which in turn enable companies to navigate the intricacies and achieve Regulatory success.
A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.
The European Union (EU) food and food supplement market is a constantly evolving industry, and its Regulatory changes are expected to impact the market. The changes are aimed at ensuring the safety and quality of food supplements while at the same time addressing the concerns of consumers and healthcare professionals. This blog highlights the Regulatory changes expected to occur in the EU food and food supplement market and their potential impact on the industry.
As per the European Union (EU) regulations, any cosmetic product that is to be sold within the EU must have a designated Responsible Person (RP) who is responsible for ensuring that the product complies with all the applicable regulations. The RP must be located within the EU and must possess enough technical knowledge about the product in question. Companies that do not have an EU presence must appoint a third-party RP to fulfil this obligation.
Cosmetic Product Safety Reports (CPSRs) play a vital role in the cosmetics industry. CPSRs are mandated by law in numerous countries worldwide, especially in the European Union (EU) and United Kingdom (UK) markets. The reports contain detailed information on ingredients and finished products, ensuring the safety of cosmetic products for consumers.