Nghị định 89/2012/NĐ-CP sửa Nghị định hướng dẫn Luật Dược
- Tổng hợp lại tất cả các quy định pháp luật còn hiệu lực áp dụng từ văn bản gốc và các văn bản sửa đổi, bổ sung, đính chính…
- Khách hàng chỉ cần xem Nội dung MIX, có thể nắm bắt toàn bộ quy định pháp luật hiện hành còn áp dụng, cho dù văn bản gốc đã qua nhiều lần chỉnh sửa, bổ sung.
thuộc tính Nghị định 89/2012/NĐ-CP
Cơ quan ban hành: | Chính phủ |
Số công báo: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Số công báo. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
Số hiệu: | 89/2012/NĐ-CP |
Ngày đăng công báo: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Ngày đăng công báo. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
Loại văn bản: | Nghị định |
Người ký: | Nguyễn Tấn Dũng |
Ngày ban hành: | 24/10/2012 |
Ngày hết hiệu lực: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Ngày hết hiệu lực. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
Áp dụng: | |
Tình trạng hiệu lực: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Tình trạng hiệu lực. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
Lĩnh vực: | Y tế-Sức khỏe |
TÓM TẮT VĂN BẢN
Mỗi cá nhân chỉ được quản lý 1 địa điểm kinh doanh thuốc
Ngày 24/10/2012, Chính phủ đã ban hành Nghị định số 89/2012/NĐ-CP sửa đổi, bổ sung một số điều của Nghị định số 79/2006/NĐ-CP ngày 09/08/2006 của Chính phủ quy định chi tiết thi hành một số điều của Luật Dược, quy định mỗi cá nhân chỉ được cấp 01 Chứng chỉ hành nghề dược và chỉ được quản lý chuyên môn một hình thức tổ chức kinh doanh tại 01 địa điểm kinh doanh thuốc.
Cũng theo Nghị định này, công dân Việt Nam muốn cấp Chứng chỉ hành nghề dược không cần phải nộp sơ yếu lý lịch và bản cam kết thực hiện các quy định của các văn bản quy phạm pháp luật về dược có liên quan. Như vậy, từ ngày 10/12/2012, hồ sơ đề nghị cấp Chứng chỉ hành nghề dược đối với công dân Việt Nam bao gồm: Đơn đề nghị cấp Chứng chỉ hành nghề dược; bản sao có chứng thực các văn bằng chuyên môn; giấy xác nhận về thời gian thực hành ở cơ sở được hợp pháp do người đứng đầu cơ sở đó cấp; bản sao có chứng thực Giấy chứng minh nhân dân (trường hợp gửi hồ sơ bằng đường bưu điện); giấy chứng nhận sức khỏe do cơ quan y tế có thẩm quyền cấp trong thời hạn 12 tháng; 02 ảnh chân dung.
Chứng chỉ hành nghề dược được cấp 01 lần, có giá trị trong phạm vi cả nước. Đối với Chứng chỉ hành nghề dược đã được cấp với thời hạn 05 năm, khi hết hạn, cá nhân phải làm thủ tục cấp lại tại cơ quan Nhà nước có thẩm quyền.
Nghị định này có hiệu lực thi hành kể từ ngày 10/12/2012.
Xem chi tiết Nghị định89/2012/NĐ-CP tại đây
tải Nghị định 89/2012/NĐ-CP
CHÍNH PHỦ --------------------- Số: 89/2012/NĐ-CP | CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc ----------------------------- Hà Nội, ngày 24 tháng 10 năm 2012 |
Nơi nhận: - Ban Bí thư Trung ương Đảng; - Thủ tướng, các Phó Thủ tướng Chính phủ; - Các Bộ, cơ quan ngang Bộ, cơ quan thuộc CP; - VP BCĐ TW về phòng, chống tham nhũng; - HĐND, UBND các tỉnh, TP trực thuộc TW; - Văn phòng Trung ương và các Ban của Đảng; - Văn phòng Tổng Bí thư; - Văn phòng Chủ tịch nước; - Hội đồng Dân tộc và các Ủy ban của Quốc hội; - Văn phòng Quốc hội; - Tòa án nhân dân tối cao; - Viện kiểm sát nhân dân tối cao; - Kiểm toán Nhà nước; - Ủy ban Giám sát tài chính Quốc gia; - Ngân hàng Chính sách xã hội; - Ngân hàng Phát triển Việt Nam; - UBTW Mặt trận Tổ quốc Việt Nam; - Cơ quan Trung ương của các đoàn thể; - VPCP: BTCN, các PCN, Trợ lý TTCP, Cổng TTĐT, các Vụ, Cục, đơn vị trực thuộc, Công báo; - Lưu: Văn thư, KGVX (3b). | TM. CHÍNH PHỦ THỦ TƯỚNG Nguyễn Tấn Dũng |
THE GOVERNMENT No. 89/2012/ND-CP | SOCIALISTREPUBLIC OF VIETNAM Hanoi, October 24th2012 |
DECREE
AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE GOVERNMENT S DECREE NO. 79/2006/NĐ-CP DATED AUGUST 09TH2006 DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE LAW ON PHARMACY
Pursuant to the Law on Government organization dated December 25th2001;
Pursuant to the Law on Pharmacy dated June 14th2005;
At the proposal of the Minister of Health;
The Government promulgates a Decree to amend and supplement a number of articles of the Government s Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy,
Article 1. Amending and supplementing a number of articles of the Government s Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy as follows:
1. Clause 2 Article 14 is amended as follows:
“Article 14. The pharmaceutical practice certificate
2. Each individual is only issued with one pharmaceutical practice certificate and only allowed to manage one form of business at a location of medicine trading.”
2. Article 16 is amended and supplemented as follows:
“Article 16. The dossier of application for the issuance or reissuance of the pharmaceutical practice certificate
1. The dossier of application for the issuance or reissuance of the pharmaceutical practice certificate is made in one set.
2. A dossier of application for the issuance or reissuance of the pharmaceutical practice certificate, applicable to Vietnamese citizens, comprises:
a) The application for the pharmaceutical practice certificate made under the form provided the Ministry of Health;
b) The authenticated copies of professional qualifications;
c) The certificate of the internship in a legal pharmaceutical establishment made and issued by its leader under the form provided by the Ministry of Health, except for the bachelors of pharmacy graduated from a transferring program that registered for opening drug stores;
d) The authenticated copy of the ID card if the dossier is sent by post, or its photocopy and the original presented for comparison if the dossier is submitted directly;
dd) The certificate of health issued by a competent health agency within the previous 12 months;
e) 2 portrait pictures 4 cm x 6 cm taken within the previous 06 months as from the day of submitting the dossier.
3. A dossier of application for the pharmaceutical practice certificate in Vietnam, applicable to foreigners or Vietnamese residing overseas, comprises:
a) The papers prescribed in Point a, b, c, dd and e Clause 2 this Article;
b) The judicial résumé certified by the competent agency of the host country, or the work permit and the written certification of the membership of a the Board of Directors of the medicine-trading establishment;
c) The authenticated copy of the passport if the dossier is sent by post, or its photocopy and the original presented for comparison if the dossier is submitted directly;
The qualifications in pharmacy and other papers prescribed in Point c Clause 2 and Point b Clause 3 this Article issued, certified, or notarized by a foreign organization. Such papers must be consularly legalized and translated into Vietnamese; the Vietnamese translation must be notarized as prescribed by Vietnam’s law.
4. A dossier of application for the replacing the pharmaceutical practice certificate that has been lost, damaged, or expired (applicable to the issued certificates valid for 5 years); or the personal information of the individual registered for pharmaceutical practice on the pharmaceutical practice certificate is changed, comprises:
a) The application for the replacement of the pharmaceutical practice certificate made under the form provided the Ministry of Health;
b) The original of the issued pharmaceutical practice certificate, unless the pharmaceutical practice certificate is lost;
c) 2 portrait pictures 4 cm x 6 cm taken within the previous 06 months as from the day of submitting the application.”
3. Article 17 is amended and supplemented as follows:
“Article 17. Validity and expiry of pharmaceutical practice certificates
The pharmaceutical practice certificate is issued once and valid nationwide. When the pharmaceutical practice certificates valid for 5 years expire, the individuals must apply for reissuing the pharmaceutical practice certificate at competent State agencies”.
4. Article 18 is amended and supplemented as follows:
“Article 18. The procedures for and authority to issue and reissue pharmaceutical practice certificates
1. IF the dossier of application for the issuance or reissuance of the pharmaceutical practice certificate is not valid, the receiving agency must return it to the applicant within 03 working days as from receiving it.
2. If the dossier of application for the pharmaceutical practice certificate is valid, the receiving agency must appraise it and issue or reissue the pharmaceutical practice certificate within 10 working days. The refusal must be informed and explained in writing by the receiving agency.
3. The authority to issue and reissue pharmaceutical practice certificates are specified in Clause 3 Article 13 of the Law on Pharmacy. The pharmaceutical practice certificate is made in two copies: one copy is kept by the issuing agency, one copy is kept by the applicant.
4. The Ministry of Health shall provide the form of the pharmaceutical practice certificate .”
5. Article 19a is added after Article 19 as follows:
“Article 19a. Returning the pharmaceutical practice certificate
1. The State management agency that receives the dossier of application for the Certificate of fulfillment of conditions for trading medicines to the individual that registered for pharmaceutical practice in the following cases:
a) The pharmaceutical manager of the medicine-trading establishment is replaced;
b) The medicine-trading establishment shuts down;
c) The establishment applies for the Certificate of fulfillment of conditions for trading medicines but then receives the refusal from the receiving agency;
d) The applicant for the pharmaceutical practice certificate (applicable to the certificates valid for 5 years).
2. The Ministry of Health shall provide the procedures for returning the pharmaceutical practice certificate.”
6. Article 28 is amended and supplemented as follows:
“Article 28. The dossier of application for the issuance, adjustment, extension, or reissuance of the Certificate of fulfillment of conditions for trading medicines
1. The dossier of application for the issuance of the Certificate of fulfillment of conditions for trading medicines comprises:
a) The application for the issuance of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;
b) The original of the pharmaceutical practice certificate of the pharmaceutical manager in accordance with the form of business, and the authenticated copy of the Certificate of business household registration, or the Certificate of Enterprise registration, signed and stamped by the establishment owner (applicable to enterprises);
c) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed;
d) The agents of medicine-trading enterprises, and wholesale agents of vaccine and medicinal products must submit the authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) to certify the agent contract between the enterprise and the head of the agent, apart from the papers prescribed in Point a, b and c this Clause.
2. The dossier of application for expanding the business in the Certificate of fulfillment of conditions for trading medicines comprises:
a) The application for expanding the scale of medicine trading made under the form provided the Ministry of Health;
b) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the Certificate of fulfillment of conditions for trading medicines and the Certificate of Enterprise registration or the Certificate of business household registration;
c) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed.
3. The dossier of application for the extension of the Certificate of fulfillment of conditions for trading medicines, applicable to the Certificates prescribed in Clause 4 Article 1 of this Decree, comprises:
a) The application for the extension of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;
b) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the Certificate of fulfillment of conditions for trading medicines;
c) The original of the pharmaceutical practice certificate of the pharmaceutical manager in accordance with the form of business;
d) The technical documents corresponding to the business conditions that need inspection as prescribed by the Ministry of Health in case the medicine-trading establishment must be assessed.
4. The application for the reissuance of the Certificate of fulfillment of conditions for trading medicines that has been lost or damaged, for the replacement of the pharmaceutical manager; for the change of the name of the medicine-trading establishment without changing its location; for the change of the location in case it is not the location registered in the Certificate of fulfillment of conditions for trading medicines, comprises:
a) The application for the reissuance of the Certificate of fulfillment of conditions for trading medicines made under the form provided by the Ministry of Health;
b) The original of the pharmaceutical practice certificate of the pharmaceutical manager when replacing the pharmaceutical manager;
c) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the written approval for the change of the name of the medicine-trading establishment decided by the business registration agency when changing the name of the medicine-trading establishment;
d) The authenticated copy or a copy signed and stamped by the establishment owner (applicable to enterprises) of the written approval for the change of the location of the medicine-trading establishment decided by the business registration agency when changing the location of the medicine-trading establishment.”
7. Article 29 is amended and supplemented as follows:
“Article 29. Validity and expiry of the Certificate of fulfillment of conditions for trading medicines
1. The Certificate of fulfillment of conditions for trading medicines is issued to the medicine-trading establishment that satisfy the standards of Good practice in accordance with the form of medicine trading. When the certificate valid for 5 years expires, the trading establishment must follow the procedures for the reissuance at a competent State agency.
2. The medicine-trading establishments that are not required to satisfy the standards of Good practice, the Certificates of fulfillment of conditions for trading medicines are valid for 5 years as from the date of issue or until the commencement date of applying the standards of Good practice. If wishing to continue the business after the Certificate of fulfillment of conditions for trading medicines expires, the organization or individual must apply for the extension as prescribed in Clause 6 Article 1 of this Decree. The extension period is 05 years or until the time limit provided by the Ministry of Health.
3. The validity period of the new Certificate of fulfillment of conditions for trading medicines is equivalent to the remaining time of the lost or replaced certificate.”
8. The name of Article 30 and Clause 1, Clause 2 Article 30 are amended and supplemented as follows:
“Article 30. The procedures and authority to issue, reissue, extend, and expand the Certificate of fulfillment of conditions for trading medicines
1. The procedures for the issuance, reissuance, extension, and expansion of the Certificate of fulfillment of conditions for trading medicines are specified as follows:
a) If the medicine-trading establishment must be assessed, within 40 working days as from receiving the valid dossier of application for the issuance, expansion, or extension of the Certificate of fulfillment of conditions for trading medicines, the receiving agency must assess it and issue, expand, or extend the Certificate of fulfillment of conditions for trading medicines;
b) If assessment is not compulsory, the receiving agency must issue, reissue, expand, or extend the Certificate of fulfillment of conditions for trading medicines within 20 working days;
c) If the dossier of application for the issuance, expansion, or extension of the Certificate of fulfillment of conditions for trading medicines is not valid, the receiving agency must inform the applicant in writing within 10 working days so that they can supplement and complete the dossier.
2. The authority to issue, reissue, extend, and expand the Certificate of fulfillment of conditions for trading medicines is prescribed in Clause 3 Article 11 of the Law on Pharmacy. The Certificate of fulfillment of conditions for trading medicines is made in two copies: one copy is kept by the issuing agency, one copy is kept by the applicant.”
Article 2. Transitional provisions
The dossiers of application for the pharmaceutical practice certificate or Certificate of fulfillment of conditions for trading medicines being submitted before this Circular takes effect shall be assessed and issued with the pharmaceutical practice certificate or Certificate of fulfillment of conditions for trading medicines in accordance with the Government s Decree No. 79/2006/NĐ-CP dated August 09th2006 detailing the implementation of a number of articles of the Law on Pharmacy.
Article 3. Implementation provisions
1. This Decree takes effect on December 10th2012.
2. This Decree annuls Clause 2 Article 14, Article 16, Article 17, Article 18, Article 28, Article 29, the name of Article 30, Clause 1 and Clause 2 Article 30 of the Government s Decree No. 79/2006/NĐ-CP dated August 09th 2006 detailing the implementation of a number of articles of the Law on Pharmacy.
Article 5. Responsibility to organize the implementation
1. The Minister of Health shall guide and organize the implementation of this Decree.
2. The Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, the Presidents of People’s Committees of central-affiliated cities and provinces, and relevant organization are responsible for the implementation of this Decree./.
| FOR THE GOVERNMENT |
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