Circular No. 02/2007/TT-BYT provides detailed guidance on implementing certain provisions regarding pharmaceutical business conditions as stipulated in the Drug Law and Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Drug Law.

CIRCULAR

Detailed guidance on implementing certain provisions regarding conditions for pharmaceutical business operations

as prescribed by the Pharmacy Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006

of the Government detailing the implementation of certain provisions of the Pharmacy Law

________________________

Pursuant to the Pharmacy Law No. 34/2005-QH11 dated June 14, 2005;

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government detailing functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law;

The Ministry of Health provides detailed guidance on implementing certain provisions regarding conditions for pharmaceutical business operations as prescribed by the Pharmacy Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing the implementation of certain provisions of the Pharmacy Law (hereinafter referred to as Decree No. 79/2006/NĐ-CP) as follows:

I. GENERAL PROVISIONS

This Circular applies to units under the Ministry of Education and Training; departments of education and training, education and training divisions; preschool education institutions, general education institutions, regular education institutions, teacher training colleges, college of education, universities, universities, academies, other educational institutions, and related organizations and individuals (hereinafter referred to collectively as agencies and units).

a) This Circular provides detailed guidance on implementing certain provisions regarding conditions for pharmaceutical business operations; locations for establishing retail outlets in various forms such as pharmacy counters, drug sales agencies, medicine cabinets at village health stations; certificates for traditional medical practitioners, traditional pharmacists, certificates for traditional herbal prescriptions, and qualifications in traditional Chinese medicine; models of pharmaceutical practice certificates, and certificates of compliance with pharmaceutical business conditions.

b) This Circular applies to Vietnamese organizations and individuals, overseas Vietnamese; foreign organizations and individuals conducting pharmaceutical business operations in Vietnam.

2. Principles of Guidance

a) This Circular only stipulates those articles, clauses, and points assigned to the Ministry of Health for detailed implementation under the Pharmacy Law and Decree No. 79/2006/NĐ-CP.

b) Organizations and individuals engaged in pharmaceutical business operations must comply with the provisions of the Pharmacy Law, Decree No. 79/2006/NĐ-CP, this Circular, and other related regulatory documents.

In this technical regulation, the following terms are understood as follows:

The business locations of enterprises for pharmaceutical products are direct production, wholesale, retail, storage, or testing sites located either at the main office or branch offices, which must be certified as meeting pharmaceutical business conditions according to the Pharmacy Law.

II. CONDITIONS FOR PHARMACEUTICAL BUSINESS OPERATIONS

1. Conditions for Pharmaceutical Business Operations

a) The professional manager must hold a Pharmaceutical Practice Certificate as stipulated in Article 15 of Decree No. 79/2006/NĐ-CP.

b) Technical facilities and personnel must meet the phased implementation of good practices standards appropriate to each type of pharmaceutical business operation as stipulated in Articles 21, 22, 23, 24, 25, and 26 of Decree No. 79/2006/NĐ-CP.

c) Rights, obligations, and scope of activities of pharmaceutical business establishments are defined in Articles 15, 16, 18, 22, 23, 26, 27, 28, 30, 31, 33, and 34 of the Pharmacy Law.

2. Conditions for Wholesale Pharmaceutical Business Locations of Enterprises

a) Conditions for pharmaceutical business operations at each wholesale location of enterprises shall be implemented according to Article 22 of Decree No. 79/2006/NĐ-CP.

b) For wholesale locations existing before June 1, 2003 where the professional manager is a secondary-level pharmacist: the pharmaceutical business enterprise must have a training plan, staff arrangement, or restructuring of the business system to appoint someone who meets the requirements stipulated in point a, Clause 3, Article 15 of Decree No. 79/2006/NĐ-CP as the professional manager, no later than December 31, 2010.

3. Conditions for Retail Pharmaceutical Business Locations of Enterprises

The conditions for operating pharmaceuticals at each retail drug selling point of enterprises shall be carried out in accordance with the provisions of Article 23 of Decree No. 79/2006/NĐ-CP.

4. Retail drug establishments as prescribed in Clause 2, Article 24 of the Medicine Law.

a) The form of organization for retail drug sales within wholesale establishments shall be implemented in accordance with the provisions of Point a, b, c, Clause 1, Article 24 of the Medicine Law.

b) The form of organization for retail drug sales within medical examination and treatment establishments includes pharmacies, drug counters, medicine cabinets of health stations or specialized traditional medicine establishments.

The director of medical examination and treatment establishments shall be responsible for all activities of retail establishments within such establishments.

c) Retail drug establishments within wholesale establishments and within medical examination and treatment establishments must comply with the conditions for operating pharmaceuticals stipulated in Clause 1, Part II of this Circular and register business operations in accordance with the law.

5. Areas where retail drug establishments can be opened in the forms of drug counters, enterprise drug agencies, and medicine cabinets of health stations.

a) Drug counters may be opened in the districts and communes of suburban and exurban counties of provinces and centrally-administered cities.

b) For areas in urban districts and wards that have not yet had enough one pharmacy to serve 2,000 people, in 2007, the Provincial Health Department shall consider organizing new drug counters, and subsequently report to the Ministry of Health with a document to review and decide on extending or opening additional drug counters based on local circumstances.

c) Retail drug establishments managed by a pharmacist with a secondary education who was already operating in urban districts and wards of cities and towns before June 1, 2003, if they do not meet the requirement of having a bachelor's degree pharmacist to convert into a pharmacy but satisfy the conditions regarding premises and equipment as stipulated for retail drug establishments, will continue to operate until December 31, 2010.

d) Enterprise drug agencies may be opened in the districts and communes of suburban and exurban counties of provinces and centrally-administered cities.

đ) Retail drug establishments of enterprises in DakNong, DakLak, Gia Lai, Kon Tum, Lam Dong, Bac Can, Cao Bang, Dien Bien, Ha Giang, Lai Chau, Lao Cai, Son La, Yen Bai, which were extended to operate until December 31, 2005, according to Circular No. 09/2004/TT-BYT dated April 9, 2004, of the Ministry of Health guiding amendments and supplements to some articles of Circular No. 01/2004/TT-BYT guiding private practice of medicine and pharmacy, if they do not meet the requirement of having a bachelor's degree or secondary education pharmacist to convert into a pharmacy or drug counter but satisfy the conditions regarding premises and equipment as stipulated for retail drug establishments, will continue to operate until December 31, 2010.

e) Medicine cabinets of health stations may be organized in the communes of suburban and exurban counties of provinces and centrally-administered cities.

Provisions on certificates of traditional physician, traditional pharmacist, certificates of family herbal remedies, and qualifications in traditional Chinese medicine and pharmacology.

a) Types of certificates in traditional Chinese medicine and pharmacology:

- Bachelor's or vocational high school diploma in Traditional Chinese Medicine.

- Certificate of traditional physician or traditional pharmacist issued by training institutions designated by the Ministry of Health to train and issue certificates;

- Certificate of family herbal remedies issued by the Ministry of Health or the Provincial Health Department prior to Circular No. 01/2004/TT-BYT dated January 6, 2004, of the Ministry of Health guiding private practice of medicine and pharmacy coming into effect.

- Certificate of traditional physician or traditional pharmacist issued by the Ministry of Health or the Provincial Health Department prior to Circular No. 01/2004/TT-BYT dated January 6, 2004, of the Ministry of Health guiding private practice of medicine and pharmacy coming into effect.

- Certificate of qualification in traditional Chinese medicine and pharmacology issued by the Ministry of Health or the Provincial Health Department.

b) Provisions on certificates of professional managers in pharmacology at traditional medicine production, wholesale, and retail establishments:

- Professional managers in pharmacology of traditional medicine production establishments registered as cooperatives or individual businesses must hold one of the certificates specified in Point a, b, e, Clause 1, Article 15 of Decree No. 79/2006/NĐ-CP and Paragraphs 1, 2, 3, 4, and 5 of Point a of this clause.

- Professional managers in pharmacology of wholesale herbal medicine, traditional medicine, and herbal medicine establishments must hold one of the certificates specified in Point a, b, e, Clause 1, Article 15 of Decree No. 79/2006/NĐ-CP and Paragraphs 1, 2, 3, 4, and 5 of Point a of this clause.

- Professional managers in pharmacology of finished traditional medicine and herbal medicine retail establishments must hold one of the certificates specified in Point a, b, e, Clause 1, Article 15 of Decree No. 79/2006/NĐ-CP and Paragraphs 1, 2, 4, and 5 of Point a of this clause.

7. Provisions on signs of pharmaceutical business establishments.

The content of signs of pharmaceutical business establishments must ensure the following basic information:

a) Name of the pharmaceutical business establishment (fully recorded according to the business registration certificate), including all business locations of enterprises.

b) Address: fully record the main office address, branch office address, and the address of the business location (if outside the main office address or branch office address).

c) Full name and professional qualifications of the owner of the retail establishment or the professional manager in pharmacology of the pharmaceutical business establishment.

d) Scope of business: fully recorded according to the certificate of compliance with pharmaceutical business conditions.

đ) Business license number, period of operation, contact phone number, fax number (if available).

8. Changes or delegation of professional personnel in pharmaceutical business establishments.

a) In cases where the owner of the retail establishment or the professional manager is absent and cannot directly manage, the pharmaceutical business establishment must temporarily cease operations or implement the following regulations:

- If the absence is less than three days, the professional manager must delegate in writing to a person with equivalent professional qualifications.

- If the absence is more than three days but less than thirty days, the professional manager must delegate in writing to a person with equivalent professional qualifications, and submit a written report to the Provincial Health Department at the location where the establishment is operating, including cases where the establishment has a business license issued by the Ministry of Health.

- If the absence period is from 30 to 180 days, the professional manager must delegate authority in writing to a person with equivalent qualifications, submit a written report to the agency issuing the business registration certificate for pharmaceuticals, and obtain written approval from this agency.

- If the absence period exceeds 180 days, the pharmaceutical business entity must process the application for issuance of a new Pharmaceutical Practice Certificate for another professional manager, apply for a new business registration certificate for retail pharmacies, and change the business registration certificate for other types of businesses.

b) During the delegation period, the delegate, the delegator, and the legal representative of the enterprise shall be responsible under the law for the professional activities of the entity if there are any violations related to professional matters.

c) In case of changes in personnel responsible for specialized departments such as production management, quality control, quality assurance, pharmacy... the pharmaceutical business entity must notify the agency issuing the business registration certificate for pharmaceuticals within 15 days from the date of change.

9. File issue, change, extend, reissue Pharmaceutical Practice Certificates

The dossier for issuing, changing, extending, and reissuing Pharmaceutical Practice Certificates is stipulated in Article 16 of Decree No. 79/2006/NĐ-CP.

10. File issue, supplement, extend, reissue, change Business Registration Certificates for pharmaceuticals

The dossier for issuing, supplementing, extending, reissuing, and changing Business Registration Certificates for pharmaceuticals is stipulated in Article 28 of Decree No. 79/2006/NĐ-CP.

11. Procedures and authorities for issuing, changing, extending, and reissuing Pharmaceutical Practice Certificates

a) The procedures for issuing, changing, extending, and reissuing Pharmaceutical Practice Certificates are implemented according to the provisions of Clause 1, Article 18 of Decree No. 79/2006/NĐ-CP.

b)The Ministry of Health establishes advisory councils to review and recommend the Minister of Health to issue, change, extend, and reissue Pharmaceutical Practice Certificates for individuals holding foreign-accredited professional qualifications who wish to practice pharmacy in foreign-invested enterprises.

c) For individuals holding Vietnamese-accredited professional qualifications, the Ministry of Health delegates provincial Department of Healths to issue, change, extend, and reissue Pharmaceutical Practice Certificates for individuals wishing to practice pharmacy in wholesale and retail foreign-invested pharmaceutical enterprises.

d) Provincial Department of Healths establish advisory councils to review and recommend the Director of the Department of Health to issue, change, extend, and reissue Pharmaceutical Practice Certificates according to the provisions of Point b, Clause 3, Article 13 of the Pharmacy Law and the cases stipulated in Point c of this clause.

đ) The Pharmaceutical Practice Certificate shall be made in two copies: one copy retained by the issuing authority and one copy handed over to the individual requesting issuance, change, extension, or reissuance.

12. Procedures and authorities issue, supplement, extend, reissue, change Business Registration Certificates for pharmaceuticals

a) The procedures for issuing, supplementing, extending, reissuing, and changing Business Registration Certificates for pharmaceuticals are implemented according to the provisions of Clause 1, Article 30 of Decree No. 79/2006/NĐ-CP.

b) The Ministry of Health issues, supplements, extends, reissues, and changes Business Registration Certificates for pharmaceuticals for entities producing medicines, providing medicine storage services, and conducting medicine testing services.

c) For traditional Chinese medicine manufacturing entities, herbal medicine manufacturing entities registered as individual businesses, entities producing medicines listed in Category I of the Drug Registration Regulations issued together with Decision No. 3121/2001/QĐ-BYT dated August 17, 2001 by the Minister of Health, and entities producing external liquid preparations from herbs, the Ministry of Health delegates provincial Department of Healths to issue, supplement, extend, reissue, and change Business Registration Certificates for pharmaceuticals.

d) Provincial Department of Healths issue, supplement, extend, reissue, and change Business Registration Certificates for pharmaceuticals according to the provisions of Point b, Clause 3, Article 11 of the Pharmacy Law and the cases stipulated in Point c of this clause.

đ) The Ministry of Health and provincial Department of Healths form inspection teams to review the dossiers and inspect pharmaceutical business entities. The results of the inspections are reported to the leadership of the Ministry of Health or provincial Department of Health for consideration on whether to issue or not issue the business registration certificate for pharmaceuticals without the need to establish an advisory council.

A pharmaceutical business entity that has met the Good Manufacturing Practices (GMP), Good Storage Practices (GSP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), and Good Pharmacy Practices (GPP) standards and whose professional manager holds a Pharmaceutical Practice Certificate does not need to resubmit the list of staff, specialized equipment, and technical facilities in the dossier for issuing, supplementing, extending, reissuing, or changing Business Registration Certificates for pharmaceuticals. The Ministry of Health and provincial Department of Healths will issue, supplement, extend, reissue, or change Business Registration Certificates for pharmaceuticals without the need for a reinspection.

III. IMPLEMENTATION PROVISIONS

1. This Circular takes effect 15 days after its publication in the Official Gazette.

2. Abolish the provisions on private pharmacy practice, vaccines, medical products, and traditional Chinese medicine practice at Circular No. 01/2004/TT-BYT dated January 6, 2004 of the Ministry of Health guiding private medical and pharmaceutical practice, Circular No. 09/2004/TT-BYT dated April 9, 2004 of the Ministry of Health amending and supplementing some articles of Circular No. 01/2004/TT-BYT guiding private medical and pharmaceutical practice, Circular No. 10/2002/TT-BYT dated July 4, 2002 guiding conditions for pharmaceutical practice, and Decision No. 3016/1999/QĐ-BYT dated October 6, 1999 of the Minister of Health on the organization and operation of hospital pharmacies.

3. Individuals and organizations that have been granted Private Pharmaceutical Practice Certificates need to build, renovate, and invest in facilities in accordance with the principles and implementation schedule of the Good Practices regulations.

Private Pharmaceutical Practice Certificates and Private Pharmaceutical Business Registration Certificates issued according to the Private Medical and Pharmaceutical Practice Ordinance remain valid until their expiration date. Three months before the expiration date, if individuals or organizations wish to continue practicing, they must process the application for issuance of a Pharmaceutical Practice Certificate and a Business Registration Certificate for pharmaceuticals according to the Pharmacy Law, Decree No. 79/2006/NĐ-CP, and this Circular.

4. Annually, provincial Department of Healths and pharmaceutical business entities report on their operations according to the prescribed model to the Ministry of Health./.