Theo quy định của pháp luật, tổ chức, cá nhân chịu trách nhiệm nhập khẩu mỹ phẩm và đưa sản phẩm mỹ phẩm vào thị trường Việt Nam có trách nhiệm công bố sản phẩm mỹ phẩm tại Cục Quản lý dược Việt nam trước khi đưa sản phẩm ra lưu hành trên thị trường. Tổ chức, cá nhân nhập khẩu mỹ phẩm chỉ được phép đưa sản phẩm mỹ phẩm ra thị trường sau khi đã công bố và có số tiếp nhận bản công bố mỹ phẩm của Cục Quản lý dược Việt nam và chịu hoàn toàn trách nhiệm về tính an toàn, hiệu quả của sản phẩm mỹ phẩm đưa ra thị trường và tuân thủ theo quy định của pháp luật Việt Nam.
Theo quy định tại điều 4 Thông tư 06/2011/TT-BYT Quy định về Quản lý Mỹ phẩm và Thông tư 32/2019/TT-BYT và Sửa đổi, bổ sung khoản 4 điều 4 và Phụ lục 01-MP Thông tư 06/2021/TT-BYT. Hồ sơ Công bố Mỹ phẩm bao gồm:
1.PHIẾU CÔNG BỐ MỸ PHẨM
- 02 bản cứng kèm theo dữ liệu công bố bản mềm
- Cần được làm theo mẫu Phụ lục 01 – MP của thông tư 06 về công bố mỹ phẩm
- Mỗi sản phẩm được công bố trong 01 phiếu công bố (một số trường hợp được công bố trong cùng 1 bản
2. GIẤY CHỨNG NHẬN LƯU HÀNH TỰ DO TẠI NƯỚC XUẤT XỨ (CFS)
- CFS do nước sở tại cấp là bản chính hoặc bản sao có chứng thực hợp lệ, còn hạn.
- CFS phải được hợp pháp hóa lãnh sự theo quy định của pháp luật, trừ trường hợp miễn hợp pháp hóa lãnh sự theo các điều ước quốc tế mà Việt Nam là thành viên
- Tham khảo: MẪU CFS CHUẨN DO BỘ Y TẾ CUNG CẤP
3. GIẤY ỦY QUYỀN – LOA
- Giấy ủy quyền là của nhà sản xuất hoặc chủ sở hữu sản phẩm ủy quyền cho tổ chức, cá nhân chịu trách nhiệm đưa sản phẩm ra thị trường được phân phối sản phẩm mỹ phẩm tại Việt Nam
- Giấy ủy quyền phải có chứng thực chữ ký và được hợp pháp hóa lãnh sự theo quy định của pháp luật, trừ trường hợp miễn hợp pháp hóa lãnh sự theo các điều ước quốc tế mà Việt Nam là thành viên
4. BẢNG THÀNH PHẦN
- Trong bộ hồ sơ công bố mỹ phẩm không thể thiếu bảng thành phần của sản phẩm mỹ phẩm
- Bảng thành phần do chính đơn vị sản xuất hoặc nhà cung cấp sản phẩm mỹ phẩm cung cấp
THỜI GIAN THỰC HIỆN CÔNG BỐ MỸ PHẨM
- Trong thời hạn 30-45 ngày làm việc kể từ ngày nhận được đầy đủ hồ sơ công bố mỹ phẩm, Cục Quản lý Dược Việt nam có trách nhiệm ban hành số tiếp nhận công bố. Sau khi có số tiếp nhận công bố mỹ phẩm, sản phẩm sẽ được lưu hành tại Việt Nam
- Hiệu lực công bố là 05 năm. Hết thời hạn hiệu lực, nếu sản phẩm vẫn tiếp tục được lưu thông trên thị trường, doanh nghiệp cần thực hiện thủ tục công bố lại cho những sản phẩm đã công bố
Anh chị cần tư vấn hỗ trợ làm HỒ SƠ NHẬP KHẨU TTBYT (LƯU HÀNH TTBYT, CÔNG BỐ A, B,…) CHUẨN CHỈNH – KHÔNG LO THU HỒI hoặc cần hỗ trợ làm thủ tục NHẬP KHẨU – VẬN CHUYỂN – THÔNG QUAN liên hệ ngay để được hỗ trợ ạ.
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