Thông tư 01/2001/TT-BYT về việc xét cấp chứng chỉ hành nghề kinh doanh dược phẩm do Bộ Y tế ban hành

CIRCULAR

ON THE CONSIDERATION OF GRANTING OF PHARMACEUTICALS TRADING PRACTICE CERTIFICATES

Pursuant to the Law on Protection of Peoples Health of July 11, 1989;
Pursuant to Enterprises Law No.13/1999/QH10 of June 12, 1999; the Government’s Decree No.02/2000/ND-CP of February 3, 2000 on business registration and Decree No.03/2000/ND-CP of February 3, 2000 guiding the implementation of a number of articles of the Enterprises Law;
Pursuant to the Government’s Decree No.11/1999/ND-CP of March 3, 1999 on goods banned from circulation, commercial services banned from provision; goods and commercial services subject to the restricted or conditional business;
Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice; the Government’s Decree No.06/CP of January 29, 1994 detailing a number of articles of the Ordinance on Private Medical and Pharmaceutical Practices;
The Ministry of Health hereby guides the consideration and granting of pharmaceutical trading practice certificates to individuals who trade in pharmaceuticals.

Chapter I

GENERAL PROVISIONS

Article 1.- Pharmaceuticals trading practice certificates (called pharmaceutical practice certificates for short) are written titles granted by the Health Ministry or the Health Services of the provinces and centrally-run cities to individuals who are professionally qualified and have adequate professional experience and practice ethics for trading in pharmaceuticals according to the provisions of the Enterprises Law on the Vietnamese territory.

Article 2.- All individuals who are fully qualified under the provisions of this Circular and wish to trade in pharmaceuticals shall be granted pharmaceutical practice certificates.

Article 3.- Subjects that must hold pharmaceutical practice certificates to make business registration according to the provisions of the Enterprises Law include:

1. One of the enterprise managers as specified in Clause 12, Article 3 of the Enterprises Law (a member of the Members Council, the companys chairman, a member of the Managing Board, Director (General Director), and other key managerial posts stated in the company charter) for a limited liability company or a joint stock company.

2. All partners of a partnership.

3. The owner or the executive manager of a private enterprise.

4. Directors or persons in charge of dependent units of an enterprise (branches, pharmacies, corporated drugstores).

5. The owner of a private drugstore.

6. The owner of a drug retail agent.

Chapter II

CRITERIA FOR BEING GRANTED PHARMACEUTICAL PRACTICE CERTIFICATES

Article 4.- General criteria:

- Possessing graduation diploma in pharmacy specialty;

- Having worked in lawful pharmaceutical establishments for a duration as prescribed for each form of pharmaceuticals trading;

- Having good health and full civil act capacity to conduct pharmaceuticals trading activities;

- Neither being subjects banned from establishing or managing enterprises prescribed in Article 9 of the Enterprises Law nor currently subject to disciplines in the pharmaceutical practice;

- Being knowledgeable about the Law on Protection of People’s Health, the legislation on private pharmaceutical and medical practice and the professional regulations relevant to the practice.

Article 5.- Regulations on professional diplomas and degrees and pharmaceutical practice period (professional practice period) of individuals to be granted practice certificates:

1. For individuals conducting pharmaceuticals trading activities in form of enterprises:

- For enterprises that only trade in pharmaceuticals: Possessing a diploma of graduation from a pharmacy university and having practiced for 5 years at a lawful pharmaceutical trading establishment.

- For enterprises that are engaged in pharmaceutical production: Possessing a diploma of graduation from a pharmacy university and having practiced for 5 years at a lawful pharmaceutical production establishment. Particularly for enterprises producing traditional medicines with their managers being galenical pharmacists, such managers must have practiced for 5 years at lawful establishments engaged in production and preparation of traditional medicines.

- For dependent units of enterprises: directors or persons in professional charge of such units must possess diplomas of graduation from a pharmacy university and have practiced for 5 years at lawful pharmaceutical establishments.

2. For individuals conducting pharmaceuticals trading activities in form of private drugstores:

Possessing diplomas of graduation from a pharmacy university and having practiced for 5 years at lawful pharmaceutical establishments.

3. For individuals conducting pharmaceuticals trading activities in form of retail sale agents:

Possessing diplomas of graduation from a pharmacy intermediate or primary school and having practiced for 2 years at lawful pharmaceutical establishment.

Chapter III

DOSSIERS, PROCEDURES AND COMPETENCE TO GRANT PHARMACEUTICAL PRACTICE CERTIFICATES

Article 6.- A dossier of application for pharmaceutical practice certificate comprises:

- The application for practice certificate (made according to the set form);

- A valid copy of the diploma of graduation from a pharmacy tertiary, intermediate or primary school or the certificate of galenical pharmacist;

- The applicant’s resume (with his/her photo) containing certification of his/her personal status (not being examined for penal liability or having his/her imprisonment sentence wiped out), and that he/she is not disciplined in pharmaceutical practice.

- The written certification of the period of working at lawful pharmaceutical establishments.

- The health certificate (issued by hospitals, polyclinics or district medical centers);

- Two photos (of size 4 cm x 6 cm);

- The commitment to comply with the Law on Protection of People’s Health, the legislation on private medical and pharmaceutical practice and professional regulations related to the pharmaceutical practice.

Article 7.- Competence to grant pharmaceutical practice certificates:

1. The Ministry of Health shall consider and grant practice certificates to individuals having diplomas of graduation from pharmacy universities or certificates of galenical pharmacists. Pharmaceutical practice certificates granted by the Ministry of Health are valid throughout the country.

2. The provincial/municipal Health Services shall grant pharmaceutical practice certificates to individuals having diplomas of graduation from pharmacy intermediate or primary schools. Pharmaceutical practice certificates granted by the provincial/municipal Health Services are valid in their respective localities.

Article 8.- Each pharmaceutical practice certificate shall be valid for 5 years.

Article 9.- The procedures for granting pharmaceutical practice certificates:

Within 30 days for the Ministry of Health and 15 days for provincial/municipal Health Services after receiving complete and valid dossiers, such bodies shall consider and grant pharmaceutical practice certificates to individuals. In case of refusal, they shall have to notify in writing the reason(s) therefor.

Each pharmaceutical practice certificate shall be made in 2 copies: One shall be sent to the applicant, another kept at the practice certificate-granting body. In case of renewal, the certificate holders shall have to return their old certificates to the granting bodies.

Chapter IV

HANDLING OF VIOLATIONS

Article 10.- Individuals granted pharmaceutical practice certificates shall be held responsible before law for professional pharmaceutical operations in their business activities. In cases where pharmaceutical practice certificate holders violate regulations on practice, they shall, depending on the seriousness of their violations, have their pharmaceutical practice certificates withdrawn temporarily or permanently.

Article 11.- Bodies competent to grant pharmaceutical practice certificates may withdraw such practice certificates from certificate grantees if the latter commit violations in one of the following cases:

- Hiring out or lending practice certificates to other people for conducting business activities;

- Trading in fake medicines;

- Repeatedly or seriously violating the professional regulations;

- Violating the regulations on professional ethics, thus igniting adverse opinions in the society;

- Failing to conduct business activities for one year after being granted pharmaceutical practice certificates.

Chapter V

IMPLEMENTATION PROVISIONS

Article 12.- This Circular takes effect 15 days after its signing for promulgation. The previous documents which are contrary to this Circular are all now annulled.

The Vietnam Pharmaceutical Management Department, the Health Ministry’s Inspectorate and concerned departments and sections, the Health Services of the provinces and centrally-run cities shall have to implement this Circular.

---------------

This document is handled by Luật Dương Gia. Document reference purposes only. Any comments, please send to email: dichvu@luatduonggia.vn