Circular No. 01/2001/TT-BYT guiding the issuance of practice certificates for pharmaceutical business

CIRCULAR

Guidelines for the issuance of certificates of practice for pharmaceutical business

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Pursuant to the Law on Health Care for the People dated July 11, 1989,

Pursuant to the Enterprise Law No. 13/1999/QH10 dated June 12, 1999; Government Decree No. 02/2000/NĐ-CP dated February 3, 2000 on business registration and Government Decree No. 03/2000/NĐ-CP dated February 3, 2000 guiding the implementation of certain provisions of the Enterprise Law;

Pursuant to Government Decree No. 11/1999/NĐ-CP dated March 3, 1999 on prohibited goods and services, restricted trade activities, and trade activities subject to conditions;

Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice; Government Decree No. 06/CP dated January 29, 1994 guiding certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice;

The Ministry of Health guides the issuance of certificates of practice for pharmaceutical business for individuals engaged in pharmaceutical business,

Chapter 1:

GENERAL PROVISIONS

Article 1. A certificate of practice for pharmaceutical business (referred to as a pharmaceutical practice certificate) is a document issued by the Ministry of Health or the Provincial Health Department to individuals who meet the required professional qualifications, work experience, and professional ethics to engage in pharmaceutical business in accordance with the Enterprise Law within the territory of Vietnam.

Article 2. Individuals meeting the criteria set forth in this Circular and having a desire to engage in pharmaceutical business shall be granted a pharmaceutical practice certificate.

Article 3. The following entities must have a pharmaceutical practice certificate to register their business in accordance with the Enterprise Law:

1. One of the managers of a limited liability company or joint stock company as stipulated in Clause 12, Article 3 of the Enterprise Law (members of the Board of Members, Chairman of the Company, members of the Board of Directors, General Director (Managing Director), other important management positions as provided in the Company Charter).

2. All general partners of a partnership.

3. The owner or manager of a sole proprietorship.

4. The director or person responsible for a subsidiary unit of a business (branch, pharmacy, company's drugstore).

5. The owner of a private pharmacy.

6. The owner of a retail drug agency.

Chapter 2:

CRITERIA FOR THE ISSUANCE OF PHARMACEUTICAL PRACTICE CERTIFICATES

Article 4. General Standards:

- Must hold a degree in pharmaceutical science.

- Must have sufficient working time in legitimate pharmaceutical establishments according to the type of pharmaceutical business.

- Must be physically fit and capable of civil conduct to engage in pharmaceutical business.

- Must not belong to the categories prohibited from establishing or managing businesses under Article 9 of the Enterprise Law and must not currently be disciplined in pharmaceutical practice.

- Must understand the Law on Health Care for the People, laws on private medical and pharmaceutical practice, and relevant professional regulations related to the field of pharmaceutical practice.

Article 5. Regulations on academic qualifications and years of pharmaceutical practice for individuals to obtain a pharmaceutical practice certificate:

1. For individuals engaging in pharmaceutical business through enterprises:

- For enterprises solely engaged in pharmaceutical sales: Hold a bachelor’s degree in pharmacy and have five years of practical experience at a legitimate pharmaceutical establishment.

- For enterprises engaged in pharmaceutical production:

Hold a bachelor’s degree in pharmacy and have five years of practical experience at a legitimate pharmaceutical production facility. For traditional medicine manufacturing enterprises, if the enterprise manager is a licensed pharmacist, they must have five years of practical experience at a legitimate traditional medicine production or preparation facility.

- For dependent units of enterprises: The directors or persons responsible for professional matters in these units must hold a bachelor’s degree in pharmacy and have five years of practical experience at a legitimate pharmaceutical establishment.

2. For individuals engaging in pharmaceutical business through private pharmacies: Hold a bachelor’s degree in pharmacy and have five years of practical experience at a legitimate pharmaceutical establishment.

3. For individuals engaging in pharmaceutical business through retail agencies: Hold a secondary or vocational degree in pharmacy and have two years of practical experience at a legitimate pharmaceutical establishment.

Chapter 3:

APPLICATIONS, PROCEDURES, AND AUTHORITY TO ISSUE PHARMACEUTICAL PRACTICE CERTIFICATES

Article 6. Application for issuance of a pharmaceutical practice certificate:

- Request for issuance of a pharmaceutical practice certificate

- Certified copy of the bachelor’s, secondary, or vocational degree in pharmacy or a certificate of licensed pharmacist;

- Curriculum vitae (with photo) confirmed regarding personal status (not being pursued for criminal responsibility, not convicted of imprisonment but has been pardoned, not currently being disciplined in pharmaceutical practice);

- Certificate of employment time at legitimate pharmaceutical establishments;

- Health certificate (issued by a general hospital, multi-specialty clinic, or district health center);

- Two photographs (4x6 cm);

- Understanding and commitment to comply with the Law on Health Care for the People, laws on private medical and pharmaceutical practice, and relevant professional regulations related to pharmaceutical practice.

Article 7. Authority to issue pharmaceutical practice certificates:

1. The Ministry of Health issues pharmaceutical practice certificates to individuals holding a bachelor’s degree in pharmacy or a certificate of licensed pharmacist. Pharmaceutical practice certificates issued by the Ministry of Health are valid nationwide.

2. The Provincial Health Department issues pharmaceutical practice certificates to individuals holding a secondary or vocational degree in pharmacy. Pharmaceutical practice certificates issued by the Provincial Health Department are valid in the respective locality.

Article 8. Pharmaceutical practice certificates are valid for five years.

Article 9. Procedures for issuing pharmaceutical practice certificates:

Within thirty days for the Ministry of Health and fifteen days for the Provincial Health Department from the date of receipt of complete and valid applications, these authorities will consider issuing pharmaceutical practice certificates to individuals; in cases where issuance is denied, a written response stating the reasons must be provided.

The pharmaceutical practice certificate will be made in duplicate: one copy sent to the applicant, one copy retained by the issuing authority. In case of renewal, the holder of the pharmaceutical practice certificate is responsible for returning the old certificate to the issuing authority.

Chapter 4:

HANDLING VIOLATIONS

Article 10. Individuals granted a pharmaceutical practice certificate must bear legal responsibility for professional pharmaceutical activities in business operations. In cases where holders of pharmaceutical practice certificates violate the regulations on practice, depending on the severity of the violation, their pharmaceutical practice certificates may be temporarily or permanently revoked.

Article 11. The authority issuing pharmaceutical practice certificates will revoke the certificate if the holder violates any of the following circumstances:

- Lease or lend the pharmaceutical practice certificate to others for business purposes.

- Engage in the sale of counterfeit drugs.

- Violate professional regulations repeatedly or seriously.

- Violate ethical practice standards causing negative public opinion in society.

- Fail to conduct business activities within one year from the date the pharmaceutical practice certificate is issued.

Chapter 5:

IMPLEMENTING PROVISIONS

Article 12. This Circular shall take effect fifteen days from the date of issuance, and all previous documents with content contrary to this Circular shall be abolished.

The Vietnam National Pharmaceutical Administration, the Inspectorate under the Ministry of Health, relevant Departments and Bureaus under the Ministry of Health, and the Provincial/Municipal Health Services directly under the central government shall be responsible for implementing this Circular.