Thông tư 02/2007/TT-BYT hướng dẫn thi hành điều kiện kinh doanh thuốc quy định Luật dược Nghị định 79/2006/NĐ-CP

CIRCULAR

GUIDING IN DETAIL THE IMPLEMENTATION OF A NUMBER OF ARTICLES ON DRUG-DEALING CONDITIONS PRESCRIBED BY THE PHARMACY LAW AND THE GOVERNMENT'S DECREE NO. 79/2006/ND-CP OF AUGUST 9, 2006, DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE PHARMACY LAW

Pursuant to Pharmacy Law No. 34/2005-QH11 of June 14, 2005;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, specifying the functions, tasks, powers and organizational apparatus of the Health Ministry;
Pursuant to the Government's Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law;
The Health Ministry hereby guides in detail the implementation of a number of article on drug-dealing conditions prescribed by the Pharmacy Law and Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law (hereinafter referred to as Decree No. 79/2006/ND-CP) as follows:

I. GENERAL PROVISIONS

1. Governing scope and subjects of application

a/ This Circular guides in detail the implementation of a number of provisions on drug-dealing conditions; geographical areas where drug-retailing establishments in the form of drugstores, drug agents, commune health stations' medicine chests may be opened; diplomas for galenic physicians or herbalists, certificates of traditional drug prescriptions and traditional medicine and pharmacy qualifications; the form of pharmaceutical practice certificate and the form of certificate of full satisfaction of drug dealing conditions.

b/ This Circular applies to Vietnamese organizations and individuals, overseas Vietnamese; foreign organizations and individuals conducting drug business in Vietnam.

2. Principles of guidance

a/ This Circular only details articles, clauses and points assigned by the Pharmacy Law and Decree No. 79/2006/ND-CP to the Health Ministry to guide the implementation.

b/ Drug-dealing organizations and individuals shall abide by the provisions of the Pharmacy Law, Decree No. 79/2006/ND-CP, this Circular and other relevant legal documents.

3. Interpretation of terms

Drug-dealing locations of enterprises mean locations where drugs are directly manufactured, wholesaled, retailed or preserved or where drug-testing services are provided, which are at the same places of, or places other than, their headquarters or branch offices, and must be granted certificates of full satisfaction of drug-dealing conditions under the provisions of the Pharmacy Law.

II. DRUG-DEALING CONDITIONS

1. Drug-dealing conditions

a/ Professional managers possess the pharmaceutical practice certificates provided for in Article 15 of Decree No. 79/2006/ND-CP.

b/ The material and technical foundations and personnel meet the schedule for implementation of good practice standards suitable to each form of drug dealing under the provisions of Articles 21, 22, 23, 24, 25 and 26 of Decree No. 79/2006/ND-CP.

c/ The rights and obligations, the scopes of operation of drug-dealing establishments are defined in Articles 15, 16, 18, 22, 23, 26, 27, 28, 30, 32, 33 and 34 of the Pharmacy Law.

2. Conditions on drug-wholesaling locations of enterprises

a/ The drug-dealing conditions for drug-wholesaling locations of enterprises are defined in Article 22 of Decree No. 79/2006/ND-CP.

b/ For drug-wholesaling locations which were opened before June 1, 2003, whose professional managers are pharmacists of intermediate level, the business establishments must work out plans on training and arrangement of professional personnel or reorganize their business system to arrange people who meet the conditions prescribed at Point a, Clause 3, Article 15 of Decree No. 79/2006/ND-CP as professional managers by December 31, 2010, at the latest.

3. Conditions on drug-retailing locations of enterprises

The drug-dealing conditions on drug-retailing locations of enterprises are defined in Article 23 of Decree No. 79/2006/ND-CP.

4. Drug-retailing establishments as prescribed in Clause 2, Article 24 of the Pharmacy Law

a/ Forms of drug retail in wholesaling establishments are defined at Items a, b and c, Clause 1, Article 24 of the Pharmacy Law.

b/ Forms of drug retail in medical examination and treatment establishments cover drugstores, drug counters, medicine chests of health stations or traditional medicine or pharmaceutical drug-selling establishments.

Directors of medical examination and treatment establishments shall take responsibility for the entire operations of retailing locations in their medical examination and treatment establishments.

c/ Drug-retailing locations in wholesaling establishments or medical examination and treatment establishments must comply with the drug-dealing conditions prescribed in Clause 1, Section II of this Circular and make business registration according to provisions of law.

5. Geographical areas in which drug-retailing establishments in forms of drug counters, drug sale agents of enterprises, medicine chests of health stations may be opened

a/ Drug counters may be opened in districts, communes of suburban districts of provinces or centrally run cities.

b/ For urban districts and wards of cities or towns where drugstores are not enough with one for every 2,000 inhabitants, in 2007, provincial/municipal Health Services shall consider and open new drug counters, then later send reports to the Health Ministry for consideration and decision to extend the operation of existing drug counters or open new ones, depending on the local situation.

c/ Drug-retailing establishments with professional managers who are pharmacists of intermediate level, which were set up before June 1, 2003, and are operating in urban districts, wards of cities or towns and are not yet qualified to turn into drugstores due to the lack of pharmacists of university degree but meet the conditions on material foundations and equipment prescribed for drug-retailing establishments, may have their operations extended to the end of December 31, 2010.

d/ Drug sale agents of enterprises may be opened in rural districts, communes of suburban districts of provinces or centrally run cities.

e/ Drug-retailing establishments of enterprises in the provinces of Dak Nong, Dak Lak, Gia Lai, Kon Tum, Lam Dong, Bac Kan, Cao Bang, Dien Bien, Ha Giang, Lai Chau, Lao Cai, Son La and Yen Bai, which had their operations extended to the end of December 31, 2005, under the Health Ministry's Circular No. 09/2004/TT-BYT of April 9, 2004, guiding amendments and supplements to a number of articles of Circular No. 01/2004/TT-BYT guiding the private medical and pharmaceutical practice and are not eligible to turn into drugstores or drug counters due to the lack of pharmacists of university degree but satisfy the conditions on material foundations and equipment prescribed for drug retailing, may have their operations extended to the end of December 31, 2010.

f/ Medicine chests of health stations may be organized in communes or suburban districts of provinces or centrally run cities.

6. Provisions on diplomas for galenic physicians, herbalists, certificates of traditional medicine prescriptions, and traditional medicine and pharmacy qualifications

a/ Diplomas of traditional medicine and pharmacy

- University or intermediate vocational school diploma in traditional medicine;

- Certificate of galenic physician or herbalist granted by an establishment designated by the Health Ministry;

- Certificates of traditional drug prescription, issued by the Health Ministry or a provincial/municipal Health Service before the effective date of the Health Ministry's Circular No. 01/2004/TT-BYT of January 6, 2004, guiding the private medical and pharmaceutical practice.

- Certificate of galenic physician or herbalist, issued by the Health Ministry or a provincial/municipal Health Service before the effective date of the Health Ministry's Circular No. 01/2004/TT-BYT of January 6, 2004, guiding the private medical and pharmaceutical practice.

- Certificate of traditional medicine or pharmacy qualifications, issued by the Health Ministry or a provincial/municipal Health Service.

b/ Provisions on diplomas for professional pharmaceutical managers at establishments producing, wholesaling or retailing traditional medicines or drugs from pharmaceuticals:

- Professional pharmaceutical managers of establishments producing traditional medicines or drugs from pharmaceuticals, which are registered to operate in the form of cooperatives or individual households, must possess one of the diplomas specified at Points a, b, f, Clause 1, Article 15 of Decree No. 79/2006/ND-CP and Items 1, 2, 3, 4 and 5, Point a of this Clause.

- Professional managers of establishments wholesaling pharmaceuticals, traditional medicines or drugs from pharmaceuticals must possess one of the diplomas specified at Points a, b, f Clause 1, Article 15 of Decree No. 79/2006/ND-CP and Items 1, 2, 3, 4 and 5, Point a of this Clause.

- Professional managers of establishments retailing finished traditional medicines or finished drugs from pharmaceuticals must possess one of the diplomas specified at Point a, b, f, Clause 1, Article 15 of Decree No. 79/2006/ND-CP and Items 1, 2, 4 and 5, Point a of this Clause.

7. Provisions on signboards of drug-dealing establishments

A signboard of a drug-dealing establishment must fully contain the following basic information:

a/ The name of the drug-dealing establishment (the full name written in the business registration certificate), including the business locations of the enterprise.

b/ The addresses of the head office, branch offices and business locations (if outside the head office or branch offices).

c/ The full name and professional qualifications of the owner of the drug-retailing establishment or the professional pharmaceutical manager of the drug-dealing establishment.

d/ The business scope, as indicated in the certificate of full satisfaction of drug-dealing conditions.

e/ The serial number of the certificate of full satisfaction of drug-dealing conditions, operation duration, telephone number, and fax number (if any).

8. Replacement or authorization of professionals at drug-dealing establishments

a/ When the retailing establishment owner or professional manager is absent or unable to directly run the drug-dealing establishment, the establishment must temporarily stop operations or comply with the following regulations:

- If the absence lasts for less than 3 days, the professional manager shall authorize in writing a person with equivalent professional qualifications to take his/her place.

- If the absence lasts between over 3 days and under 30 days, the professional manager shall authorize in writing a person with equivalent professional qualifications to take his/her place and send a written report thereon to the provincial/municipal Health Service of the locality where the establishment is operating, even when the establishment's certificate of full satisfaction of drug-dealing conditions is granted by the Health Ministry.

- If the absence lasts between 30 and 180 days, the professional managers shall authorize in writing a person with equivalent professional qualifications to take his/her place, report in writing thereon to the agency that has granted the certificate of full satisfaction of drug-dealing conditions and get the latter's written approval.

- If the absence lasts over 180 days, the drug-dealing establishment shall carry out the procedures to request the grant of a pharmaceutical practice certificate to another professional manager and request the grant of a new certificate of full satisfaction of drug-dealing conditions to the drug-retailing establishment or renew the certificate of full satisfaction of drug-dealing conditions for business organizations of other types.

b/ During the authorization period, the authorized persons, the authorizers and the at-law representatives of enterprises shall take responsibility before law for the professional operations of the establishments if professional errors are committed.

c/ When the person in charge of a professional section such as production section, testing section, quality control section, pharmaceutical section,... is replaced, the drug-dealing establishment shall notify it to the agency which has issued the certificate of full satisfaction of drug-dealing conditions within 25 days after the replacement.

9. Dossiers for grant, renewal, extension or re-grant of pharmaceutical practice certificates

Dossiers for grant, renewal, extension or re-grant of pharmaceutical practice certificates are defined in Article 16 of Decree No. 79/2006/ND-CP.

10. Dossiers for grant, supplementation, extension, re-grant, renewal of certificates of full satisfaction of drug-dealing conditions

Dossiers for grant, supplementation, extension, re-grant, renewal of certificates of drug business certificates are defined in Article 28 of Decree No. 79/2006/ND-CP.

11. Procedures and competence for grant, renewal, extension, re-grant of pharmaceutical practice certificates

a/ The procedures for grant, renewal, extension, re-grant of pharmaceutical practice certificates are specified in Clause 1, Article 18 of Decree No. 79/2006/ND-CP.

b/ The Health Ministry shall set up advisory councils to consider and propose the Health Minister to grant, renew, extend or re-grant pharmaceutical practice certificates to individuals with professional diplomas issued by foreign training establishments, who register for medical or pharmaceutical practice with foreign investment capital.

c/ For individuals who possess professional diplomas granted by Vietnamese training establishments, the Health Ministry shall authorize provincial/municipal Health Services to grant, renew, extend or re-grant pharmaceutical practice certificates to individuals who register for pharmaceutical practice with regard to foreign-invested drug-wholesaling or -retailing establishments.

d/ Provincial/municipal Health Services shall set up advisory councils to consider and propose the Health Service directors to grant, renew, extend or re-grant pharmaceutical practice certificates according to the provisions at Point b, Clause 3, Article 13 of the Pharmacy Law and the provisions of Point c of this Clause.

e/ A pharmaceutical practice certificate is issued in two copies: One is kept at the issuing agency and one is handed to the individual applying for the grant, renewal, extension or re-grant thereof.

12. Procedures and competence for grant, supplementation, extension, re-grant or renewal of certificates of full satisfaction of drug-dealing conditions

a/ The procedures for grant, supplementation, extension, re-grant or renewal of certificates of full satisfaction of drug-dealing conditions are specified in Clause 1, Article 30 of Decree No. 79/2006/ND-CP.

b/ The Health Ministry shall grant, supplement, extend, re-grant or renew certificates of full satisfaction of drug-dealing conditions to establishments producing drugs or providing drug preservation or testing services.

c/ For establishments that produce traditional medicines or drugs from pharmaceuticals and have registered to do business in the form of individual business households, establishments that produce drugs on List I of the Drug Registration Regulation promulgated together with Decision No. 3121/2001/QD-BYT of August 17, 2001, of the Health Minister, and establishments that produce liquid medicines from pharmaceuticals for external use, the Health Ministry shall authorize provincial/municipal Health Services to grant, supplement, extend, re-grant, renew certificates of full satisfaction of drug-dealing conditions.

d/ Provincial/municipal Health Services shall grant or supplement, extend, re-grant or renew certificates of full satisfaction of drug-dealing conditions under the provisions of Point b, Clause 3, Article 11 of the Pharmacy Law and the provisions of Point c of this Clause.

e/ The Health Ministry and provincial/municipal Health Services shall set up teams to check dossiers and examine drug-dealing establishments. The examination results shall be submitted to the leadership of the Health Ministry or provincial/municipal Health Services for consideration of the grant or non-grant of certificates of full satisfaction of drug-dealing conditions without having to set up advisory councils.

If drug-dealing establishments have met the GMP, GSP, GLP, GDP, GPP standards and their professional managers possess the pharmaceutical practice certificates, the list of their staff members and the list of their professional equipment, and material and technical foundations in the dossier requesting the grant, supplementation, extension, re-grant or renewal of certificates of full satisfaction of drug-dealing conditions need not be re-submitted. The Health Ministry or provincial/municipal Health Services shall grant, supplement, extend, re-grant or renew certificates of full satisfaction of drug-dealing conditions without having to organize re-examination.

III. IMPLEMENTATION PROVISIONS

1. This Circular takes effect 15 days after its publication in "CONG BAO."

2. To annul the provisions on private practice of pharmacy, vaccines, medical bio-products and traditional pharmacy of the Health Ministry's Circular No. 01/2004/TT-BYT of January 6, 2004, guiding the private medical and pharmaceutical practice and Circular No. 09/2004/TT-BYT of April 9, 2004, guiding amendments and supplements to a number of articles of Circular No. 01/2004/TT-BYT, guiding the private medical and pharmaceutical practice; Circular No. 10/2002/TT-BYT of July 4, 2002, guiding the pharmaceutical practice conditions, and the Health Minister's Decision No. 3016/1999/QD-BYT of October 6, 1999, promulgating the Regulation on organization and operation of hospital drugstores.

3. Individuals and organizations that have been granted certificates of full satisfaction of private pharmaceutical practice conditions wishing to build, renovate or invest in their establishments shall comply with the principles and roadmap for implementation of regulations on good practice.

Private pharmaceutical practice certificates and certificates of full satisfaction of private pharmaceutical practice conditions which have been issued under the Ordinance on Private Medical and Pharmaceutical Practice continue to be valid until their expiry. At least three months before the expiry, individuals or organizations that wish to continue their professional practice shall carry out the procedures for grant of pharmaceutical practice certificates or certificates of full satisfaction of drug-dealing conditions as provided for by the Pharmacy Law, Decree No. 79/2006/ND-CP and this Circular.

4. Annually, provincial/municipal Health Services and drug-dealing establishments shall make reports on their activities according to a set form and send them to the Health Ministry.

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