nhà thuốc GPP

Sau khi ra trường, những Dược sĩ đại học mong muốn mở nhà thuốc đạt chuẩn GPP, nhưng không biết thủ tục như thế nào. Sau đây là hướng dẫn thủ tục để mở một nhà thuốc GPP đúng theo pháp luật Việt Nam.

Đầu tiên hãy cùng Thuocsi tìm hiểu về GPP và những tiêu chuẩn cho một nhà thuốc đạt chuẩn GPP.

1. GPP là gì?

GPP (Good Pharmacy Practices) là “Thực hành tốt quản lý nhà thuốc”. GPP gồm những nguyên tắc cơ bản về chuyên môn và đạo đức trong thực hành nghề nghiệp tại nhà thuốc. Nhằm đảm bảo việc sử dụng thuốc được chất lượng, hiệu quả và an toàn.

GPP là tiêu chuẩn cuối cùng và cao nhất trong 5 tiêu chuẩn thực hành tốt (GPs) trong quy trình đảm bảo chất lượng thuốc:

  • Từ khâu sản xuất: (Thực hành tốt sản xuất thuốc – GMP)
  • Kiểm tra chất lượng (Thực hành tốt kiểm nghiệm thuốc – GLP)
  • Tồn trữ bảo quản (Thực hành tốt bảo quản thuốc – GSP)
  • Lưu thông phân phối (Thực hành tốt phân phối thuốc – GDP)
  • Phân phối đến tay người bệnh (Thực hành tốt nhà thuốc – GPP)
  • Tháng 1 năm 2007, Bộ Y tế đã chính thức ban hành và áp dụng hai tiêu chuẩn GDP và GPP. Để bảo đảm tính đồng bộ và toàn diện từ sản xuất, lưu thông và phân phối lẻ. Tất cả đều vì mục tiêu nâng cao chất lượng, hiệu quả điều trị và an toàn cho cộng đồng.

2. Những tiêu chuẩn cho một nhà thuốc GPP

Tiêu chuẩn về cơ sở vật chất

  • Diện tích tối thiểu cho một nhà thuốc phải đạt 10m2. Trong đó, có đầy đủ các không gian bố trí, sắp xếp thuốc theo đúng quy định (khu trưng bày, khu bảo quản, khu mỹ phẩm…); đảm bảo các trang thiết bị, phương tiện cần thiết để bảo quản thuốc.
  • Với thuốc bán lẻ không kèm bao bì, dược sĩ bán thuốc phải ghi rõ tên thuốc, hàm lượng, nộng độ, hướng dẫn sử dụng cụ thể…

Tiêu chuẩn nhân sự

  • Người đứng tên thành lập Nhà thuốc GPP phải có bằng dược sĩ đại học và có chứng chỉ hành nghề dược của Bộ Y tế cấp. Nhân viên làm việc tại nhà thuốc phải mặc áo Blouse trắng, đeo biển ghi họ tên, chức vụ, ăn mặc gọn gàng, sạch sẽ.
  • Dược sĩ bán thuốc phải có trình độ chuyên môn nghề dược, thực hành bán thuốc theo đúng quy định, đảm bảo lợi ích, an toàn cho bệnh nhân và tuân thủ các nguyên tắc đạo đức nghề nghiệp.
  • Việc xây dựng Nhà thuốc đạt GPP không chỉ đảm bảo lợi ích cho bệnh nhân mà còn giúp nâng uy tín cho Nhà thuốc và góp phần nâng cao chất lượng dịch vụ toàn ngành dược phẩm nước nhà.

Tiêu chuẩn về hoạt động

  • Thực hiện việc ghi chép, lưu trữ và bảo quản hồ sơ tối thiểu 1 năm tính từ thời điểm thuốc hết hạn chùng; Không được thực hiện bất kỳ hành vi quảng cáo, lôi kéo khách hàng; Đảm bảo việc mua thuốc, kiểm soát chất lượng, bán thuốc không kê đơn/kê đơn, theo dõi chất lượng thuốc, bảo quản thuốc, giải quyết các trường hợp thu hồi thuốc hay khiếu nại về thuốc…

Và dưới đây Thuocsi sẽ hướng dẫn các bạn về Thủ tục đăng ký và mở nhà thuốc GPP:

3. Thủ tục đăng ký và mở nhà thuốc GPP

4 Loại giấy tờ cần phải có để chuẩn bị cho thủ tục mở nhà thuốc:

  1. Chứng chỉ hành nghề (Do Sở Y Tế cấp sau 2 năm ra trường)
  2. Giấy Chứng nhận đăng ký kinh doanh do UBND Quận/Huyện cấp.
  3. Giấy chứng nhận nhà thuốc đạt chuẩn GPP
  4. Giấy chứng nhận đủ điều kiện hành nghề (Do Sở Y Tế cấp)

A. Thủ tục xin cấp chứng chỉ hành nghề Dược

  • Hồ sơ gồm:
    1. Đơn đề nghị cấp chứng chỉ hành nghề Dược
    2. Bảng sao hợp pháp các văn bằng chuyên môn
    3. Sơ yếu lý lịch có chứng nhận của Chủ tịch ủy ban xã, phường, thị trấn nơi người đề nghị cấp chứng chỉ hành nghề cư  trú hoặc của Thủ trưởng cơ quan nơi người đó đang công tác, thời hạn không quá 6 tháng.
    4. Giấy chứng nhận sức khỏe đủ điều kiện hành nghề, thời hạn không quá 6 tháng.
    5. Giấy xác nhận về thời gian thực hành ở cơ sở dược hợp pháp do người đứng đầu cơ sở đó cấp.
    6. Bản cam kết thực hiện quy định văn bản quy phạm pháp luật về dược có liên quan
    7. Giấy cho phép hành nghề ngoài giờ nếu người xin phép là cán bộ, công chức nhà nước.
    8. 2 ảnh chân dung cỡ 4cm x 6cm
  • Thời hạn giải quyết:
    Thời gian 30 ngày, kể từ ngày nhận được hồ sơ.
  • Cơ quan thực hiện: Sở Y Tế
  • Lệ Phí: 500.000đ/lần thẩm định

B. Đăng ký thành lập hộ kinh doanh

  • Hồ sơ gồm
  1. Giấy đề nghị đăng ký hộ kinh doanh;
  2. Bản sao hợp lệ thẻ căn cước công dân hoặc Chứng minh nhân dân hoặc Hộ chiếu còn hiệu lực của các cá nhân tham gia hộ kinh doanh hoặc người đại diện hộ gia đình;
  3. Bản sao hợp lệ biên bản họp nhóm cá nhân về việc thành lập hộ kinh doanh đối với trường hợp hộ kinh doanh do một nhóm cá nhân thành lập
  • Thời gian giải quyết: thời gian 5 ngày kể từ ngày nhận được hồ sơ hợp lệ

C. Hồ sơ đề nghị cấp Giấy chứng nhận đủ Điều kiện kinh doanh dược

Trường hợp của bạn thuộc trường hợp được cấp giấy chứng nhận đủ điều kiện kinh doanh dược lần đầu.

Theo quy định tại Khoản 1 Điều 38 Luật dược 2016 và Điều 32 Nghị định 54/2017/NĐ-CP thì hồ sơ đề nghị cấp Giấy chứng nhận đủ Điều kiện kinh doanh dược bao gồm:

  1. Đơn đề nghị cấp Giấy chứng nhận đủ Điều kiện kinh doanh dược theo mẫu số 19 Phụ lục I Nghị định 54/2017/NĐ-CP;
  2. Tài liệu về địa điểm, khu vực bảo quản, trang thiết bị bảo quản, tài liệu chuyên môn kỹ thuật và nhân sự theo nguyên tắc Thực hành tốt cơ sở bán lẻ thuốc.
  3. Bản sao có chứng thực Giấy chứng nhận đăng ký doanh nghiệp hoặc tài liệu pháp lý chứng minh việc thành lập cơ sở;
  4. Bản sao có chứng thực Chứng chỉ hành nghề dược;

Ngoài ra, các bạn có thể tham khảo thêm bài viết của Thuocsi.vn về Chiến lược xây dựng nhà thuốc đạt chuẩn GPP.

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