Hồ sơ, trình tự thẩm định nhà thuốc GPP là câu hỏi đang được nhiều người quan tâm. Cùng thuocsi.vn tìm hiểu ngay!

1. Giới thiệu nhà thuốc GPP 

GPP là từ viết tắt của Good Pharmacy Practices, nghĩa là “Thực hành tốt quản lý nhà thuốc”. Gồm các nguyên tắc cơ bản về chuyên môn và đạo đức trong thực hành nghề tại nhà thuốc. 

Năm 1996, Bộ Y Tế đã ban hành và áp dụng tiêu chuẩn GMP, GLP và GSP. Đến năm 2007, Bộ Y Tế ban hàng và áp dụng thêm 2 tiêu chuẩn GDP và GPP. Nhằm bảo đảm tính đồng bộ và toàn diện từ sản xuất, lưu thông và phân phối lẻ. 

Như vậy, Nhà thuốc GPP là những nhà thuốc đã được đánh giá, kiểm định chất lượng. Đồng thời, đạt yêu cầu tiêu chuẩn cao nhất về một nhà thuốc phục vụ người tiêu dùng. 

Giới thiệu mẫu nhà thuốc GPP

2. Tiêu chuẩn công nhận thực hành tốt nhà thuốc

Để được công nhận thực hành tốt nhà thuốc, cần đáp ứng các tiêu chuẩn sau: 

– Tiêu chuẩn về cơ sở vật chất: 

Theo quy định, diện tích tối thiểu phải đạt 10m2; có đầy đủ các không gian bố trí, sắp xếp thuốc theo đúng quy chuẩn. Đồng thời, đảm bảo các trang thiết bị, phương tiện cần thiết về bảo quản thuốc. 

– Tiêu chuẩn về nhân sự: 

Người thành lập phải bằng Dược sĩ đại học và chứng chỉ hành nghề Dược của Bộ Y tế. Ngoài ra, nhân viên phải mặc áo Blouse trắng, đeo biển ghi họ tên, chức vụ.

– Tiêu chuẩn về hoạt động: 

Thực hiện lưu trữ và bảo quản hồ sơ tối thiểu 1 năm tính từ thời điểm thuốc hết hạn. Bên cạnh đó, phải đảm bảo chất lượng, giải quyết các trường hợp thu hồi hay khiếu nại về thuốc. 

3. Trình tự, thủ tục xin cấp giấy chứng nhận nhà thuốc GPP 

Để có thể xin chứng nhận thực hành tốt nhà thuốc phải tiến hành theo trình tự, thủ tục:

BƯỚC 1: Chuẩn bị hồ sơ thẩm định nhà thuốc GPP gồm những giấy tờ: 

  • Bản kê khai danh sách nhân sự 
  • Bản kê khai địa điểm bản kê khai danh sách trang thiết bị 
  • Bản sao chứng chỉ hành nghề dược do sở y tế cấp 
  • Bằng cấp chuyên môn theo danh sách nhân sự 
  • Đơn đề nghị xét GPP 
  • Giấy chứng nhận đăng ký kinh doanh của nhà thuốc 
  • Danh mục các SOP và kèm bộ SOP cơ bản 
  • Giấy chứng nhận đủ điều kiện hành nghề 
  • Đơn đăng ký kiểm tra điều kiện bán lẻ thuốc theo nguyên tắc, tiêu chuẩn GPP 
  • Bản tự kiểm tra nhà thuốc theo Danh mục kiểm tra. 
Dược sĩ tư vấn thuốc cho khách hàng

BƯỚC 2: Sở Y tế tiếp nhận và kiểm tra các giấy tờ hồ sơ:

– Trường hợp hồ sơ hợp lệ, cơ quan tiếp nhận cấp cho cơ sở phiếu tiếp nhận hồ sơ;

– Trường hợp hồ sơ chưa hợp lệ, cơ quan tiếp nhận thông báo đề nghị để bổ sung hồ sơ.

BƯỚC 3: Cán bộ tiến hành tiếp nhận và kiểm tra hồ sơ rồi gửi phiếu tiếp nhận hồ sơ: 

Trong thời hạn 20 ngày làm việc, Sở Y tế phải thành lập đoàn thẩm định, kiểm tra thực tế cơ sở bán lẻ thuốc và có biên bản thẩm định.

BƯỚC 4: Cơ quan có thẩm quyền tiến hành thẩm định và phê duyệt:

Trong thời hạn 35 ngày, Sở Y tế cấp giấy chứng nhận đủ điều kiện kinh doanh thuốc đạt chuẩn GPP cho cơ sở bán lẻ thuốc.

Nếu thẩm định không đạt yêu cầu thì cơ sở phải nộp báo cáo khắc phục. Sau đó, Sở Y tế cấp giấy chứng nhận trong vòng 55 ngày nếu thẩm định đạt yêu cầu.

Đoàn kiểm tra Sở y tế kiếm tra tại cơ sở xin thẩm định nhà thuốc GPP

BƯỚC 5: Trả kết quả thẩm định:

Đến ngày hẹn, cơ sở đến Bộ phận tiếp nhận & trả hồ sơ nhận kết quả. Hoặc nhận kết quả qua đường bưu điện đã điền thông tin trước đó.

Nếu bạn còn thắc mắc gì về hồ sơ thẩm định nhà thuốc GPP thì có thể xem thêm tại đây. Hoặc liên hệ trực tiếp với thuocsi.vn để được tư vấn miễn phí! 

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