✦ 智能摘要
Decree No. 89/2012/ND-CP amends and supplements certain Articles of Decree No. 79/2006/NĐ-CP on the management of Pharmaceutical Practice Certificates and Certificates of Adequate Conditions for Medicines Trading. This document provides detailed regulations on the files, procedures for issuing, reissuing, and extending these certificates, while also changing some contents related to the rights and obligations of pharmaceutical practitioners.
适用范围
Pharmaceutical practitioners, medicines trading establishments, the Ministry of Health, and competent state agencies issuing certificates.
要点
- Each individual may only be granted one Pharmaceutical Practice Certificate and manage professional activities at one medicines trading location.
- The application file for issuing or reissuing a Pharmaceutical Practice Certificate includes an application form, academic credentials, a practical training confirmation letter, a passport-sized photograph, and a national identity card (if required).
- The validity period of a Pharmaceutical Practice Certificate is once nationwide, with expired cases requiring reissue procedures.
- The review process for the application file for issuing or reissuing a Certificate of Adequate Conditions for Medicines Trading is detailed, with a maximum processing time of 40 working days for cases requiring review and 20 working days for cases not requiring review.
- A Certificate of Adequate Conditions for Medicines Trading is valid for five years, and must be renewed upon expiration according to regulations.
🌐 本文件的社会影响
- Positive impact: Reducing administrative burdens for pharmaceutical practitioners and medicines trading establishments.
- Negative impact: May increase legal costs for individuals and organizations due to compliance with new regulations.
❓ 常见问题
How many Pharmaceutical Practice Certificates can each individual obtain?
Each individual may only be granted one Pharmaceutical Practice Certificate and manage professional activities at one medicines trading location.
What does the application file for a Pharmaceutical Practice Certificate include?
The file includes an application form, academic credentials, a practical training confirmation letter, a passport-sized photograph, and a national identity card (if required).
What is the validity period of a Pharmaceutical Practice Certificate?
A Pharmaceutical Practice Certificate has a validity period of once nationwide. Issued certificates have a term of five years, and must be reissued upon expiration.
How long is the review process for the application file for a Certificate of Adequate Conditions for Medicines Trading?
In cases requiring review, the maximum processing time is 40 working days; in cases not requiring review, it is 20 working days.
What is the validity period of a Certificate of Adequate Conditions for Medicines Trading?
A Certificate of Adequate Conditions for Medicines Trading is valid for five years, and must be renewed upon expiration according to regulations.
全文
DECREE
Provincial People's Committees set specific pricesto amend and supplement some articles of Decree No. 79/2006/NĐ-CPday, September 09th,June 2024;Article 8amendof 2006
specialized agency under the People's Committee of the province/city.Deputy ministers of ministerial-level agencies,a Ch"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."of the Government detailing the implementation of the Ordinance on feesi implementing some provisions of the Medicine Law
_______________________________
Pursuant to the Law Torganization C"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Government on December 25thJune 2024;energy 12001;
Pursuant to the Medicine Law of 1June 4, 2005;
At the proposal of the Minister of Healththereof;
The Government promulgates this Decree amending and supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9June 2024;Article 8amend2006 concerningDeputy ministers of ministerial-level agencies,a Ch"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."of the Government detailing the implementation of the Ordinance on feesi implementing some provisions of the Medicine Law,
Article 1. Amending and supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law as follows:iArticle of the Medicine Law as follows:
1. Clause 2 of Article 14 is amended as follows:
"Article 14. Professional Practice Certificate for Pharmacy
2. Each individual may only be issued one Professional Practice Certificate for Pharmacy and may only manage the professional affairs of one form of business organization at one place of drug business."
2. Article 16 is amended and supplemented as follows:
"Article 16. Application Documents for Issuing, Reissuing Professional Practice Certificate for Pharmacy
1. The application documents for issuing, reissuing Professional Practice Certificate for Pharmacy shall be made in one set.
2. The application documents for issuing Professional Practice Certificate for Pharmacy for Vietnamese citizens include:
a) An application form for issuing Professional Practice Certificate for Pharmacy according to the model prescribed by the Ministry of Health;
b) Certified copies of relevant academic certificates;
c) A certificate confirming the period of practice at a legitimate pharmacy establishment issued by the head of that establishment according to the model prescribed by the Ministry of Health, except in cases where a graduate of a part-time undergraduate pharmacy program registers for a pharmacy;
d) Certified copies of Identity Card if the application is sent by post or original Identity Card presented for verification if submitted in person;
đ) A health certificate issued by a competent health authority within twelve months;
e) Two recent passport-sized photographs taken within six (06) months prior to the date of submission of the application for issuance of the Professional Practice Certificate.
3. The application documents for issuing Professional Practice Certificate for Pharmacy in Vietnam for foreign individuals, overseas Vietnamese, include:
a) The documents specified in Points a, b, c, đ and e of Clause 2 of this Article;
b) Criminal record clearance from the competent authority of the country of residence or Work Permit and Certificate confirming membership on the Board of Directors or Management Board of a pharmaceutical business establishment;
c) Certified copies of passport if the application is sent by post or original passport presented for verification if submitted in person.
Academic certificates related to pharmacy and other documents specified in Point c of Clause 2 and Point b of Clause 3 of this Article issued by foreign agencies or organizations must be legalized and translated into Vietnamese; the translation must be notarized in accordance with Vietnamese law.
4. The application documents for reissuing Professional Practice Certificate for Pharmacy due to loss, damage, deterioration; expiration (for certificates issued with a five-year validity period); changes in personal information registered on the Professional Practice Certificate, include:
a) An application form for reissuing Professional Practice Certificate for Pharmacy according to the model prescribed by the Ministry of Health;
b) Original Professional Practice Certificate already issued, except in cases where the Professional Practice Certificate has been lost;
c) Two recent passport-sized photographs taken within six (06) months prior to the date of submission of the application for issuance of the Professional Practice Certificate.”
3. Article 17 is amended and supplemented as follows:
"Article 17. Validity and Duration of Professional Practice Certificate for Pharmacy
The Professional Practice Certificate for Pharmacy is issued once and is valid throughout the country. For Professional Practice Certificates for Pharmacy issued with a five-year validity period, upon expiration, the individual must apply for reissuance of the Professional Practice Certificate for Pharmacy at the competent state agency."
4. Article 18 is amended and supplemented as follows:
"Article 18. Procedures and Authority for Issuing, Reissuing Professional Practice Certificate for Pharmacy
1. In case of non-compliant applications, the receiving agency shall return the application documents to the applicant within three working days from the date of receipt of the application for issuing, reissuing Professional Practice Certificate for Pharmacy.
2. In case of compliant applications, the receiving agency shall organize the review and issue, reissue the Professional Practice Certificate for Pharmacy within thirty working days from the date of receipt of the application for issuing Professional Practice Certificate for Pharmacy or within ten working days from the date of receipt of the application for reissuing Professional Practice Certificate for Pharmacy; if not issued, reissued, the receiving agency shall provide a written response stating the reasons.
3. The authority for issuing, reissuing Professional Practice Certificate for Pharmacy shall be carried out in accordance with Clause 3 of Article 13 of the Medicine Law. The Professional Practice Certificate for Pharmacy shall be made in two copies: One copy retained by the issuing agency, one copy given to the applicant.
4. The Ministry of Health shall prescribe the format of the Professional Practice Certificate for Pharmacy.”
5. Supplement Article 19a after Article 19 as follows:
"Article 19a. Return of Professional Practice Certificate for Pharmacy
1. The competent state management agency receiving the application for issuing a Certificate of Eligibility for Pharmaceutical Business shall return the Professional Practice Certificate for Pharmacy to the individual applying for pharmacy practice in the following cases:
a) The pharmaceutical business establishment changes the professional manager;
b) The pharmaceutical business establishment ceases operations;
c) The establishment submits an application for issuing a Certificate of Eligibility for Pharmaceutical Business but receives a refusal notice from the receiving agency;
d) The individual applies for reissuance of Professional Practice Certificate for Pharmacy (for certificates issued with a five-year validity period).
2. The Ministry of Health shall prescribe the procedures and formalities for returning the Professional Practice Certificate for Pharmacy.”
6. Article 28 is amended and supplemented as follows:
"Article 28. Application Documents for Issuing, Supplementing, Extending, Reissuing Certificate of Eligibility for Pharmaceutical Business
1. The application documents for issuing Certificate of Eligibility for Pharmaceutical Business include:
a) An application form for issuing Certificate of Eligibility for Pharmaceutical Business according to the model prescribed by the Ministry of Health;
b) Original Professional Practice Certificate for Pharmacy of the professional manager corresponding to the form of business organization and certified copies of Individual Business Registration Certificate or Enterprise Registration Certificate or certified copies with signature of the owner and stamp confirmation (if it is a company);
c) Technical documents corresponding to the conditions of business requested to be inspected according to the regulations of the Ministry of Health for cases requiring inspection of the pharmaceutical business establishment;
d) For pharmaceutical business enterprises' drug sales agents and wholesale vaccine and medical products distributors, in addition to the documents specified in Points a, b, and c of this Clause, they must also provide a certified copy or a copy signed by the head of the establishment and stamped for confirmation (if it is a business enterprise) of the agency contract between the enterprise establishing the agency and the head of the agency.
2. The application dossier for supplementing the scope of pharmaceutical business operations in the Certificate of Compliance with Conditions for Pharmaceutical Business Operations includes:
a) An application form for supplementing the scope of pharmaceutical business operations according to the model prescribed by the Ministry of Health;
b) A certified copy or a copy signed by the head of the establishment and stamped (if it is a business enterprise) of the previously issued Certificate of Compliance with Conditions for Pharmaceutical Business Operations and the Enterprise Registration Certificate or the Business Household Registration Certificate;
c) Technical documentation corresponding to the business conditions as stipulated by the Ministry of Health for cases requiring assessment of the pharmaceutical business operation premises.
3. The application dossier for extending the validity period of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations for certificates with a specified validity period as provided for in Clause 7, Article 1 of this Decree includes:
a) An application form for extending the validity period of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations according to the model prescribed by the Ministry of Health;
b) A certified copy or a copy signed by the head of the establishment and stamped (if it is a business enterprise) of the previously issued Certificate of Compliance with Conditions for Pharmaceutical Business Operations;
c) The original Professional Practice Certificate of the new specialized manager for pharmaceuticals in cases where there is a change in the specialized manager for pharmaceuticals;
d) Technical documentation corresponding to the business conditions as stipulated by the Ministry of Health for cases requiring assessment of the pharmaceutical business operation premises.
4. The application dossier for reissuing the Certificate of Compliance with Conditions for Pharmaceutical Business Operations due to loss, damage, or deterioration; changes in the specialized manager for pharmaceuticals; changes in the name of the pharmaceutical business operation without changing the business location; changes in the registered business address when the registered business address is not the operational business location already certified by the Certificate of Compliance with Conditions for Pharmaceutical Business Operations includes:
a) An application form for reissuing the Certificate of Compliance with Conditions for Pharmaceutical Business Operations according to the model prescribed by the Ministry of Health;
b) The original Professional Practice Certificate of the new specialized manager for pharmaceuticals in cases where there is a change in the specialized manager for pharmaceuticals;
c) A certified copy or a copy signed by the head of the establishment and stamped by the establishment (if it is a business enterprise) of the approval document for changing the name of the pharmaceutical business operation from the business registration authority in cases where there is a change in the name of the pharmaceutical business operation;
d) A certified copy or a copy signed by the head of the establishment and stamped by the establishment (if it is a business enterprise) of the approval document for changing the registered business address from the business registration authority in cases where there is a change in the registered business address.
7. Article 29 is amended and supplemented as follows:
"Article 29. Value and Validity Period of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations
1. The Certificate of Compliance with Conditions for Pharmaceutical Business Operations is issued once to a pharmaceutical business operation that meets the principles and standards of Good Practices appropriate to the form of pharmaceutical business. For certificates issued with a five-year validity period, upon expiration, the pharmaceutical business operation must apply for reissue at the competent state authority.
2. For pharmaceutical business operations following a phased approach that are not yet required to meet the principles and standards of Good Practices, the Certificate of Compliance with Conditions for Pharmaceutical Business Operations has a validity period of five years from the date of issuance or until the deadline for implementing the principles and standards of Good Practices. When the Certificate of Compliance with Conditions for Pharmaceutical Business Operations expires, if wishing to continue operating, individuals or organizations must submit an extension application dossier in accordance with Clause 6, Article 1 of this Decree. Each extension period is five years or until the deadline set out in the phased approach prescribed by the Ministry of Health.
3. The usage period of the reissued Certificate of Compliance with Conditions for Pharmaceutical Business Operations due to loss or replacement is equivalent to the remaining validity period of the lost or replaced Certificate of Compliance with Conditions for Pharmaceutical Business Operations."
8. The title of Article 30 and Clauses 1 and 2 of Article 30 are amended and supplemented as follows:
"Article 30. Procedures and Authority for Issuance, Reissuance, Extension, and Supplementing the Scope of Business in the Certificate of Compliance with Conditions for Pharmaceutical Business Operations
1. The procedures for issuance, reissuance, extension, and supplementing the scope of business in the Certificate of Compliance with Conditions for Pharmaceutical Business Operations are as follows:
a) For cases requiring assessment of the pharmaceutical business operation premises (concurrent issuance), within a maximum of forty working days from the date of receipt of a valid application dossier for issuance, supplementation, or extension of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations, the receiving authority must organize the assessment and issue, supplement, or extend the Certificate of Compliance with Conditions for Pharmaceutical Business Operations;
b) For cases not requiring assessment of the pharmaceutical business operation premises, within a maximum of twenty working days, the receiving authority must issue, reissue, supplement, or extend the Certificate of Compliance with Conditions for Pharmaceutical Business Operations;
c) In cases where the application dossier for issuance, reissuance, supplementation, or extension of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations is incomplete, within ten working days from the date of receipt of the dossier, the receiving authority must issue a notification to the organization or individual applying for issuance, reissuance, supplementation, or extension of the Certificate of Compliance with Conditions for Pharmaceutical Business Operations to complete the dossier.
2. The authority for issuance, reissuance, extension, and supplementing the scope of business in the Certificate of Compliance with Conditions for Pharmaceutical Business Operations shall be carried out in accordance with Clause 3, Article 11 of the Drug Law. The Certificate of Compliance with Conditions for Pharmaceutical Business Operations shall be made in two copies: One copy retained by the issuing authority and one copy given to the applicant organization or individual.
Article 2.iTransitional Provisions
Application dossiers for the Professional Practice Certificate of Pharmacists and the Certificate of Compliance with Conditions for Pharmaceutical Business Operations submitted before the effective date of this Decree shall be assessed and issued the Professional Practice Certificate of Pharmacists and the Certificate of Compliance with Conditions for Pharmaceutical Business Operations in accordance with Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the GovernmentDeputy ministers of ministerial-level agencies, on detailed implementation of certain provisions of the Drug Law.
Article 3. Implementation Provisions
1. This Decree takes effect from December 10, 2012.
2. This Decree abolishes Clause 2 of Article 14, Article 16, Article 17, Article 18, Article 28, Article 29, the name of Article 30, Clause 1 and Clause 2 of Article 30 of Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Medicine Law.Deputy ministers of ministerial-level agencies,c
||| Article 4. ResponsibilitiesiThe Minister of Health shall be responsible for guiding and organizing the implementation of this Decree.
1. Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairmen of provincial and centrally-run city People's Committees, and related agencies, organizations, and individuals shall be responsible for implementing this Decree./.
2. co authority under the Government, the Chairman The People's Committees of provinces and centrally-run cities, and related agencies, organizations, and individuals shall be responsible for implementing this Decree./.
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89/2012/NĐ-CP
Decree No. 89/2012/ND-CP amends and supplements certain Articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Medicine Law.
Expired
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译本
本文件提供以下语言版本：
Tiếng Việt
Nghị định số 89/2012/NĐ-CP Sửa đổi, bổ sung một số điều của Nghị định số 79/2006/NĐ-CP ngày 09 tháng 8 năm 2006 của Chính phủ quy định chi tiết thi hành một số điều của Luật Dược
한국어
89/2012/NĐ-CP號政令對2006年8月9日第79/2006/NĐ-CP號政令的部分條款進行修改和補充，該政令詳細規定實施《藥品法》的若干條款。
中文
令第89/2012/NĐ-CP修正和补充第79/2006/NĐ-CP号政府法令关于《药品法》若干条款的具体实施细则