授权代表 | 化妆品

您的化妆品责任人

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我们为您提供化妆品责任人的服务，确保您的产品合规，高效地进入欧盟市场。

化妆品在欧盟的销售

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根据欧盟化妆品法规 (CE) 1223/2009，非欧盟的制造商必须指定一名责任人 (PR) 才能在欧盟销售化妆品。化妆品责任人会全权负责产品的安全性和法律合规性。

在欧盟销售的所有化妆品都必须遵守欧盟化妆品法规(CE) 1223/2009的规定，以确保内部市场的合法运作和对人体健康的高度保护。

在欧盟销售的所有化妆品都必须由质量受权人进行安全评估。

持有的产品信息档案 (PIF) 中必须包含化妆品安全报告 (CPSR)。

作为责任人，CMC可以帮助制造商履行与其义务相关的特定任务。这包括撰写、编制和维护产品信息档案 (PIF)、编写化妆品安全报告 (CPSR)、在化妆品通报门户 (CPNP) 上注册化妆品，以及帮助制造商准备良好生产规范 (GMP)，以记录和规范化妆品的生产、控制、存储和发货。

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后台栏目

摘要

Frequently asked questions about TGA Registration

Is the TGA sponsor responsible for the quality or safety of my products?

No, while the sponsor ensures that the products comply with Australian regulations and manages communication with the TGA, the foreign manufacturer is ultimately responsible for the quality and safety of their products.

Can my Australian distributor act as my TGA sponsor?

Yes, your distributor or any other individual/entity based in Australia can act as your TGA sponsor. However, it’s essential that they are qualified and willing to assume the regulatory responsibilities associated with this role.

How much does it cost to hire a TGA sponsor?

The cost varies depending on the sponsor’s services and the type of therapeutic goods being registered. It’s important to choose a reliable sponsor who can ensure compliance with TGA regulations.

What happens if I don’t have a TGA sponsor?

Without a TGA sponsor, your company cannot legally supply therapeutic goods in Australia. The sponsor is the official point of contact and is required for regulatory approval, ongoing compliance, and communication with the TGA.

Why appoint CMC Medical Devices as your TGA Sponsor?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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