Bạn đang muốn mở nhà thuốc tây và không biết có cần đăng ký kinh doanh không? Bạn không rành quy trình đăng ký như thế nào? Cùng theo dõi bài viết dưới đây để làm rõ những thủ tục đăng ký giấy phép kinh doanh nhà thuốc nhé!

Điều kiện ban đầu để kinh doanh quầy thuốc

1. Xây dựng và thiết kế

– Địa điểm cố định, bố trí ở nơi cao ráo, thoáng mát, an toàn, cách xa nguồn ô nhiễm; được tách biệt với các hoạt động khác;

– Xây dựng chắc chắn, có trần chống bụi, tường và nền nhà phải dễ làm vệ sinh, đủ ánh sáng nhưng không để thuốc bị tác động trực tiếp của ánh sáng mặt trời.

2. Diện tích

  • Diện tích phù hợp với quy mô kinh doanh nhưng tối thiểu là 10m2, phải có khu vực để trưng bày, bảo quản thuốc và khu vực để người mua thuốc tiếp xúc và trao đổi thông tin về việc sử dụng thuốc với người bán lẻ;
  • Phải bố trí thêm khu vực cho những hoạt động khác như:

+ Khu vực ra lẻ các thuốc không còn bao bì tiếp xúc trực tiếp với thuốc để bán lẻ trực tiếp cho người bệnh;

+ Kho bảo quản thuốc riêng (nếu cần);

+ Phòng hoặc khu vực tư vấn riêng cho người mua thuốc/bệnh nhân.

  • Trường hợp kinh doanh thêm mỹ phẩm, thực phẩm chức năng, dụng cụ y tế thì phải có khu vực riêng, không bày bán cùng với thuốc và không gây ảnh hưởng đến thuốc; phải có biển hiệu khu vực ghi rõ “Sản phẩm này không phải là thuốc”.
Đăng ký giấy phép kinh doanh nhà thuốc
(Ảnh: sưu tầm)

3. Điều kiện về nhân sự

Để đủ điều kiện kinh doanh nhà thuốc và hoàn thành hồ sơ giấy phép kinh doanh nhà thuốc, cần lưu ý điều kiện về nhân sự như sau:

  • Người phụ trách chuyên môn tối thiểu có bằng tốt nghiệp trung cấp ngành dược, phải có Chứng chỉ hành nghề dược theo quy định hiện hành.
  • Nhân viên trực tiếp tham gia bán thuốc, giao nhận, bảo quản thuốc, quản lý chất lượng thuốc phải có bằng cấp chuyên môn và có thời gian thực hành nghề nghiệp phù hợp với công việc được giao, trong đó:

+ Người trực tiếp bán lẻ thuốc phải có văn bằng chuyên môn dược từ sơ cấp dược trở lên.

+ Nhân viên cung cấp thông tin cho người mua thuốc độc, thuốc kê đơn phải là người phụ trách chuyên môn hoặc người có văn bằng chuyên môn dược từ trung cấp ngành dược trở lên

Giấy phép kinh doanh nhà thuốc dược sĩ cần biết

Dược sĩ nên chuẩn bị đầy đủ các loại giấy tờ dưới đây để hoàn thành hồ sơ và xin được cấp duyệt:

  • Đơn đề nghị cấp Giấy chứng nhận đủ điều kiện kinh doanh dược theo mẫu.
  • Giấy chứng nhận Thực hành tốt tại địa điểm kinh doanh (nếu có) và các tài liệu kỹ thuật 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, bao gồm:

+ Sơ đồ nhân sự, danh sách nhân sự, tên, chức danh, trình độ chuyên môn;

+ Bản vẽ bố trí các khu vực của cơ sở bán lẻ;

+ Danh mục trang thiết bị (bao gồm cả thông tin về hệ thống máy tính và phần mềm quản lý nối mạng);

+ Danh mục các quy định, hồ sơ, tài liệu, các quy trình thao tác chuẩn;

+ Bản tự kiểm tra Thực hành tốt cơ sở bán lẻ thuốc theo danh mục kiểm tra quy định tại Phụ lục II – 2a hoặc 2b hoặc 2c kèm theo Thông tư 02/2018/TT-BYT đối với cơ sở đề nghị cấp Giấy chứng nhận đủ điều kiện kinh doanh dược tương ứng.

  • Bản sao có chứng thực Giấy chứng nhận đăng ký doanh nghiệp hoặc tài liệu pháp lý chứng minh việc thành lập cơ sở.
  • Bản sao có chứng thực Chứng chỉ hành nghề dược.

* Số lượng hồ sơ: 02 bộ.

Trên đây là những thông tin về thủ tục đăng ký giấy phép kinh doanh nhà thuốc năm 2021, các anh chị lưu lại thông tin và thường xuyên theo dõi thuocsi để cập nhật những thông tin hữu ích khác nhé.

(Nguồn: sưu tầm)

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