Circular 10/2013/tt-Byt: Amendments And Supplements To Some Articles Of The Circular No. 01/2007/tt-Byt On Jan. 24, 2007 By The Minister Of Health Instructions Detailing The Implementation Of A Number Of Articles About Economic Conditions D. ..

Original Language Title: Thông tư 10/2013/TT-BYT: Sửa đổi, bổ sung một số điều của Thông tư số 02/2007/TT-BYT ngày 24 tháng 01 năm 2007 của Bộ trưởng Bộ Y tế hướng dẫn chi tiết thi hành một số điều về điều kiện kinh d...

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
MINISTRY OF HEALTH
Number: 10 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, March 29, 2013

IT ' S SMART

Edit, add some of the stats of the Digital 02 /2007/TT-BYT January 24, 2007

of the Minister of Health instruct details to enforce some things about the drug business conditions

According to the Code of Pharmacy. And the digital decree. 79 /2006/NĐ-CP August 9, 2006 Government

specify the details of the execs a number of the Laws of Pharmacy

______________________

Pharmacy Law No. 34 /2005-QH-11 June 14, 2005;

63rd Protocol. /2012/NĐ-CP August 31, 2012 The government regulates the function, duties, powers, and organizational structure of the Ministry of Health;

Base of Protocol 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain provisions of the Law of Pharmacy;

On the recommendation of the Director of the Bureau of Pharmacology,

Minister of Health, Department of Health. Change, add a number of things. Digital 02 /2007/TT-BYT January 24, 2007, of the Minister of Health, the Secretary of Health guidelines for certain conditions on the conditions of the drug business under the provisions of the Law of Pharmacy and Protocol. 79 /2006/NĐ-CP August 9, 2006, the government rules out certain provisions of the Law.

What? 1. Modified, add some of the Digital 02 /2007/TT-BYT 24/01/2007 of the Minister of Health guidelines detailed the implementation of some of the provisions of the drug business under the provisions of the Law of Pharmacy and International Protocol. 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation details the implementation of certain provisions of the Law of Pharmacy (later called Digital Digital) 02 /2007/TT-BYT ) as follows:

1. Clause 9 Section II is modified as follows:

" 9. Grant file, grant certificate of drug practice

The profile of the grant, issued a certificate of pharmacy, is carried out in accordance with the provisions of the Article 2 of the Decree. 89 /2012/NĐ-CP 24/10/2012 of the Government amended, adding some of the provisions of the Digital Protocol 79 /2006/NĐ-CP August 9, 2006, of the Government of the United States Regulation of Law of the Law of the Law of the United States. (the following is called the Digital Protocol) 89 /2012/NĐ-CP).

2. Clause 10 Section II is modified, added as follows:

" 10. The profile of the offer, reissued, extension, adds business scope in the Certificate of qualified drug business.

a) The proposed record, tier, extension, addition of business scope in the Certificate of qualified drug business is carried out in accordance with Article 6 Article 1 of the Digital Protocol. 89 /2012/NĐ-CP.

b) The case of a grant, radical, extension, addition of business scope in the Certificate of Qualified Drug Business that the drug business facility has been granted a good practice certificate (GMP, GSP, GLP, GDP, GPP) is consistent with the form and scope. business, then the corresponding technical document stipulated in paragraph 6 Article 1 of the digital decree 89 /2012/NĐ-CP You only need a copy of a certificate or a copy of the owner or head of the base and stamp confirmation (if it is a business) A certificate of good practice.

c) The case of a grant, tier, extension, addition of business scope in the Certificate of Qualified Drug Business (in a row) that the drug business facility has not been granted a good practice certificate (GMP, GSP, GLP, GDP, GPP) in line with the image. And the scope of the business, the technical document, is in accordance with Article 6 of the Sixth Protocol. 89 /2012/NĐ-CP is done as follows:

-For the basis of drug production: the registration record for good practice of drug production (GMP) is done in accordance with the Digital Decision. 3886 /2004/QĐ-BYT November 13, 2004, of the Minister of Health on November 13, 2004, the Minister of Health for the implementation of the implementation of the principle, the "Good Practice of the Practice of the Drug" standard, as recommended by the World Health Organization and the relevant, modified, complementary texts.

-For a drug-testing business facility: the registration record of the Good Practice Test Room (GLP) is done in accordance with the guidance at Decision No. 1. 1570 /2000/QĐ-BYT September 22, 2000 of the Minister of Health for the implementation of the implementation of the principle of "Practice of Drug Testing" and the relevant, revised, complementary text.

-For the basis of a drug preservation service business: the registration of a Good Practice for Drug Enforcement (GSP) is done in accordance with the Digital Decision. 2701 /2001/QĐ-BYT June 29, 2001, of the Minister of Health for the implementation of the implementation of the principle of "Good Practice of Drug Administration" and the relevant, revised, complementary text.

-For the drug import facility: the registration of the Good Practice for Drug Enforcement (GSP) is done in accordance with the Digital Decision. 2701 /2001/QĐ-BYT June 29, 2001 of the Minister of Health for the implementation of the implementation of the "Good Practice of Drug Administration" principle, and the relevant, modified, complementary text (Facility with direct foreign investment).

-For a wholesale basis: the registration record for good practice of distribution of drugs (GDP) is made in accordance with the Digital Information. 48 /2011/TT-BYT December 21, 2011, the Minister of Health enacted a good practice of distributing drugs.

-For the drug retail facility: the registration of the pharmacy Good Practice Test (GPP) is done in accordance with the Digital Information. 46 /2011/TT-BYT On December 21, 2011, the Minister of Health enacted principles, the standard of good practice of the pharmacy.

-For the basis of drug production from pharmaceuticals: the record offers to grant a certificate of sufficient drug production to be made in accordance with the Digital Information. 16 /2011/TT-BYT April 19, 2011, of the Minister of Health on April 19, 2011, the Minister of Health rules the principle of drug production from pharmaceuticals and roadways, the standard practice of producing drugs (GMP) for the drug production facility from the drug (later called Digital Digital). 16 /2011/TT-BYT).

-For the unimplemented drug retail facility GPP follows the implementation of the principle of applying the principle, the standard practice of pharmacy good (GPP) provided by the Ministry of Health of Health, technical documentation: location manifest and business base equipment (sample). 07 /KKĐ-TTB); the manifest of the list of personnel and qualifications (denominated 6 /KKNS). "

3. paragraph 11 Section II is modified, added as follows:

" 11. Order, authority, grant certificate of pharmacy

a) The order, the authority, the grant, the Certificate of Pharmacy Execution, is done in accordance with the provisions at paragraph 4 Article 1 Resolution 89 /2012/NĐ-CP.

b) The Ministry of Health authorized the Department of Health of the Provinces, the Central Committee of the Central Committee, reissued, revoking the certificate of drug practice to the individual registered as an administrative capital of foreign investment in the form of business: drug production, security services, and services. the drug administration, drug testing, importing drugs.

c) The provincial health department, the central city of the Central Committee, established the Advisory Council for review and the Director of the Department of Health Department, granting the Certificate of Occupation to the individual by regulation at this b point and point b 3 Article 13 Pharmacy. "

4. Add to 111b in Section II as follows:

" 11b.Presentation, procedure for return Certificate of Pharmacy Certificate for Personal Registered Pharmaceutical

The state governing body has the authority to grant a qualified certificate of drug business (later known as a competent authority) to return to the government's own practice of administing the pharmaceutical business of the drug business in the following circumstances:

a) The drug business facility changes the administrator to specialize in medicine:

-The head of the head of the facility offers a Certificate of Certified Public Business in paragraph 6 Article 1 Decree No. 89 /2012/NĐ-CP Due to the change of professional managers, the authorities have the authority to return the medical certificate of the former professional administrator to the facility, along with the Certificate of Qualified Medicine.

-A case of single-level pharmaceutical managers who submit a proposal to return to a self-employment certificate, the professional manager must inform the head of the business base about the recommendation to change the professional manager. During the 5-day period of work since the recommended recipient date of the professional manager, the authority has the authority to inform the head of the business base on having to change the professional manager. After 30 days of work since the day the agency has the authority to inform, if the business facility does not change the professional manager, the authorities have the authority to return the certificate of conduct to the professional manager simultaneously. recovery of the medical business.

b) The drug business is ending business activity:

During the 5-day period of work, since the date of receiving notification of the drug business facility on termination of operation or the basis of the drug business revoked the Certificate of Eligible Drug Business in accordance with Article 31 Digital Protocol. 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain provisions of the Law of Pharmacy (later known as Decree) 79 /2006/NĐ-CP ) then the agency has the authority to revoking the certificate of sufficient medicine to return it to the specialized manager of the self-employment certificate (except for the case of a professional manager being revoked, certificate of medicine under Article 19) Law of Pharmacy.

c) The filing facility filed for a Certificate of Certification Certificate of the drug business but received an unissued reply from the agency reception agency:

The agency has the authority to return to the basis of the exact basis of the drug practice that the facility filed in the file with an answer statement stating the reason for not granting the Certificate of Certificate of Medication Business.

d) The case of an individual who applied for the Certificate of Pharmacology

At a minimum of 60 days before the Certificate of Pharmacology of a professional manager expires, the drug business facility must submit a proposal to return to the Occupational Identity Certificate (Model 03/NCC) for the competent authority.

During the 5-day period of work, since the date received the offer to take back the drug business facility ' s drug business, the authorities have the authority to return the government to the drug business facility, and inform the facility that it has been. is granted a Certificate of Business Qualified Certification, requiring a professional manager to continue to practice until the end of the term in the Certificate of Pharmacology. Prior to the Certificate of Occupational Medicine, the drug business had to submit to the newly reissued medicinal certificate. If the Occupational Therapy of a professional manager expires, the facility does not submit a new practice certificate or the procedure to change the specialized manager, the competent agency will revoking the certificate of sufficient business conditions under the rules. at the point b 1 Article 31 Decree number 79 /2006/NĐ-CP. "

5. paragraph 12 Section II is modified, added as follows:

" 12. The order, the authority to grant, grant, renew, add business scope in the Certificate of qualified drug business.

a) The order, the authority, the authority, the extension, the extension, the addition of the business scope in the Certificate of Qualified Medicine 89 /2012/NĐ-CP.

b) The non-licensed drug business base cases (GMP, GSP, GLP, GDP, GPP) are consistent with the form and scope of business that is applied to the order, tier, extension, the addition of business scope in the Certificate of Identification. It is eligible for a drug business to be able to judge a drug business.

c) The case of the proposed, radical, extension, business scope supplement in the Certificate of Qualified Drug Business has received the Certificate of Good practices (GMP, GSP, GLP, GDP, GPP) in effect, in line with the form and scope of the product. business that applies self-level, radical, extension, business-to-business supplements in a Certificate of Qualified Drug Business, not to specify a business basis by regulation at paragraph 8 Article 1 Decree No. 89 /2012/NĐ-CP.

d) The case of a Certificate of Qualified Certificate of the drug business at 4 paragraph 6 Article 1 Resolution No. 89 /2012/NĐ-CP apply the order not to specify a business base by regulation at paragraph 8 Digital Decree 89 /2012/NĐ-CP.

The order, the authority to grant, grant, renew, add a business scope in a Certificate in Certificate of Drug Business to the basis of drug production from the drug on the deployment of the implementation of the principle, the standard "Good practice of drug production". -(GMP) ": executed by regulation at Digital Information 16 /2011/TT-BYT.

e) The case must be the basis of the facility, the Ministry of Health, the Department of Health into the division of the drug business facility. The results of the appraisal to the Leader of the Ministry of Health or the Department of Health to consider granting or not granting a Certificate of Certificate in Drug Business without the establishment of the Advisory Council. "

6. Add paragraph 13 to Section II:

" 13. Apply some of the principle content, the standard "Drug Practice" standard for retail facilities is in the course of good practice implementation (not required to apply the GPP).

The business conditions of the agent, the medical station blockers, the drug retail facility from east y, the drug from the prescribed medicine by prescribed at No. 46 /2011/TT-BYT December 21, 2011 of the Minister of Health enacted Principles, the "Good Practice of the Drug Practice" standard (the following calls for Digital) 46 /2011/TT-BYT ) Minus the rules at point b, d paragraph 2; point b paragraph 3, point c paragraph 4 items II Chapter II and point b, clause 1 section III Chapter II Principles, the standard "Home Good Practice" issued with the Digital Information Act. 46 /2011/TT-BYT.

Team member: apply Article 4 Digital. 46 /2011/TT-BYT. "

7. Add paragraph 14 to Section II:

" 14. This message accompanying the following forms:

a) A grant application, the granting of the Pharmacy Certificate (Form 1a/CC, Form 1b/ĐN-CLCC);

b) The application for the return certificate for drug practice (Form 2a/LCC; 02b/ĐN-LCC);

c) Work time validation (Form 3/GXN);

d) The application application, addition, extension, reissued the Certificate of Business Qualifying Certificate (Form 4a-4b-4c-4d/K);

The paper's receipt of a certificate of a certificate of drug practice/certificate of drug business (Model 5a/BNHS, 5b/BNHS);

e) HR lists and qualifications (6/KKNS); location manifold and business base equipment (7 KKD-TTB)

g) The personal list issued, reissued, revoked Certificate of Pharmacology within the state management range of the Department of Health (Form 8a/BC-CCHN); List of licensed drug business facilities issued, reissued, extension, adding business scope in the Certificate Certificate Business conditions (Form 8b/BC-GCNKKD).

h) Certificate of pharmacy (Form 9a/CCHN, 9b/CCHN-CL);

i) The certificate is eligible for drug business (Form 10a/GCN-ĐKKD, 10b/GCN-CL, 10c/GCN-DKKD, 10d/GCN-DKKD-CL). "

What? 2. The transition clause

1. The transition clause is carried out by regulation at Article 2 of the Digital Protocol 89 /2012/NĐ-CP.

2. Certificate of pharmacy practice, Certified Certificate of qualified drug business prior to this announcement is valid for the expiration of the period in the Certificate of Pharmacy Practice, the Certificate of Medication Business.

3. Drug business facilities that have been granted sufficient license to treat the wholesale form of a wholesale form of drug and a certificate of good practice prescriptions for the drug-importing operation continue to be imported in accordance with the correct scope and time of writing. on the certificate of good practice preservation. Drug-producing facilities have been granted sufficient Certificate of Medication Business and Certification Certification Standard "Good Practice Production" (GMP) is imported raw materials for the production of the business itself of the business itself and sold to manufacturing facilities. The other drug is prescribed at the point of a 1 Article 3 point. 47 /2010/TT-BYT December 29, 2010, the Minister of Health guidelines for export operations, importing drugs and packaging directly with the drug until the expiration of the period on the Certificate of Medication Production.

4. The individuals, the facility that are allowed to file a proposed, radical, renew, business scope in the Certificate of Occupational Medicine, grant, grant a Certificate of Occupational Medicine As Soon As This Is Issued.

The manufacturing facilities, the active drug business that the Certificate of Pharmacy, the Certificate of Occupational Drugs expired after December 10, 2012 (in guidance at Clause 1 Public Works 177 /BYT-QLD on 09/1/2013 of the Ministry of Health on deployment) Number Protocol 89 /2012/NĐ-CP ) is going to continue to operate 45 days after this Private Day is in effect.

What? 3. Organizational responsibility

1. Bureau of Pharmacology, Department of Health, Central City, Central City, which is responsible for this information.

2. The Department of Drug Administration is responsible for aggregations and the publication of the information related to the grant, reissued, revoked Certificate of Pharmacy, a list of facilities issued, reissued, extension, and the addition of business scope in the Certificate of Business eligisum. The drug, revoking the Certificate of Certified Public Medication on the Department of Pharmacy information page to serve as the basis for operational deployment units, grant certificate of drug practice; level, reissue, renew, add business range in Certificate of the drug business.

3. Constants, aggregations, published lists of individuals granted, reissued, revoked Certificate of Pharmacy, list of facilities issued, reissued, renewed, supplematment of business range in Certified Certificate of Drug Business, The case was revoked, suspended business operations within the Department of Health's management to the Department of Health's electronic information page and sent data to the Department of Pharmacology to update the database on drug practice.

What? 4. Execution clause

1. This message has been in effect since 14 May 2013.

2. Repeal Section 9, Clap 10, Section 11, Section 12 Section II Private 02 /2007/TT-BYT And the sample took on the case, the drug-only certificate, the certification certificate, the executive order, issued by the Department of Medicine. 02 /2007/TT-BYT This private day is valid.

Minister.

(signed)

Nguyen Thi Kim