Circular No. 03/2009/TT-BYT stipulates the organization, management, and operation of the Good Pharmacy Practice (GPP) pharmacy chain.

CIRCULAR

Provisions on the organization, management, and operation of the Good Pharmacy Practice (GPP) pharmacy chain

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Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Drug Law No. 34/2005/QH11 dated June 14, 2005;
Pursuant to Decree No. 79/2006/ND-CP dated August 9, 2006 detailing the implementation of certain provisions of the Drug Law;

Pursuant to Decision No. 27/2007/QD-TTg dated February 15, 2007 of the Prime Minister approving the project on developing domestic trade until 2010 and orientations until 2020;

Considering the proposal of the Director of the Drug Administration Department;

The Ministry of Health stipulates the organization, management, and operation of the Good Pharmacy Practice (GPP) pharmacy chain:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the organization, management, and operation of the Good Pharmacy Practice (GPP) pharmacy chain.

Article 2. Applicability

1. Enterprises with the function of distributing drugs, having a retail system organized by the enterprise itself.

2. This Circular does not apply to enterprises engaged in trademark licensing business as prescribed in Decree No. 35/2006/NĐ-CP dated March 31, 2006 of the Government detailing the Law on Trade regarding trademark licensing business.

Article 3. Explanation of Terms

1. The retail system includes pharmacies, drug counters, drug agents, retail establishments specializing in selling traditional Chinese medicine and herbal drugs established and directly operated by the enterprise.

2. The GPP pharmacy chain consists of pharmacies meeting the GPP standards established and directly operated by the enterprise, operating under a unified quality system of the enterprise.

3. The unified quality system of the enterprise:

a) Has a quality policy in writing describing the purpose and general policy of the enterprise to ensure the implementation and application of GPP principles. This policy must be approved and published by the General Director of the enterprise or the Legal Representative.

b) Has a university-level pharmacist responsible for managing the quality of the GPP pharmacy system, appointed as Quality Manager.

c) Quality management includes: organizational structure, procedures, human resources, documentation, information systems, management systems, technical facilities, and systematic activities that meet predetermined quality requirements.

Chapter II

ORGANIZATION, MANAGEMENT AND OPERATIONS OF THE

 GOOD PHARMACY PRACTICE (GPP) PHARMACY CHAIN

Article 4. The organization of the GPP pharmacy chain must meet the following conditions

1. Is an enterprise with the function of distributing drugs and has a retail drug system organized by the enterprise.

2. Has at least five pharmacies meeting the GPP standards nationwide.

3. Meets the "Good Distribution Practices" (GDP) standard and has a warehouse meeting the "Good Storage Practices" (GSP) standard.

Article 5. Qualifications for the Quality Manager

1. Is a university-level pharmacist, with at least five years of practice experience at a legal pharmaceutical establishment.

2. Is appointed by the General Director of the enterprise or the Legal Representative to perform the dedicated role or selected from among the professional managers of pharmaceuticals at pharmacies within the GPP pharmacy chain to perform兼任职务。对于质量经理这一职位，不要求必须持有药剂执业证书。

3. Does not belong to the categories of individuals prohibited from establishing and managing enterprises as stipulated in Clause 2, Article 13 of the Enterprise Law.

Article 6. Standards for professional managers in pharmacies

The professional manager in each pharmacy within the Good Pharmacy Practice (GPP) chain must hold a Practicing Certificate in Pharmacy as stipulated in Article 14 and point a, Clause 4, Article 15 of Decree No. 79/2006/NĐ-CP dated August 9, 2006, detailing certain provisions of the Medicine Law (hereinafter referred to as Decree No. 79/2006/NĐ-CP).

Article 7. Provisions on managing the GPP pharmacy chain

1. The General Director of the enterprise or the Legal Representative of the enterprise shall be responsible for overseeing all activities of the GPP pharmacy chain. The General Director of the enterprise or the Legal Representative of the enterprise shall issue decisions appointing and assigning tasks to the Quality Director of the GPP pharmacy chain. In cases where the GPP pharmacy chain is located in multiple provinces or centrally-administered cities, it may appoint several Quality Directors to facilitate management by the enterprise.

2. The Quality Director shall be responsible for the professional activities of all pharmacies within the GPP pharmacy chain; they shall be responsible for delegating authority to individuals with equivalent professional qualifications to the pharmacy's professional manager when these individuals are absent, as provided for in Circular No. 02/2007/TT-BYT dated January 24, 2007, guiding detailed implementation of certain provisions regarding drug business conditions under the Medicine Law and Decree No. 79/2006/NĐ-CP.

3. The professional manager of each pharmacy within the GPP pharmacy chain shall be responsible for all professional activities within the pharmacy.

4. The rights of retail sellers and the professional manager of each pharmacy shall be implemented according to Clause 1, Article 27 of the Medicine Law.

5. Retail sellers of drugs within the GPP pharmacy chain may rotate between retail outlets within the chain but must register their list with the local Department of Health.

6. All activities related to the supply, circulation, storage, and preservation of drugs, as well as patient-related data at all pharmacies within the GPP pharmacy chain of the enterprise, shall be managed through unified procedures, regulations, tools, and appropriate information technology means, and must be controlled by the Quality Director according to a common plan and program of the enterprise.

7. Provisions on drug information dissemination and counseling methods:

The Quality Director and the professional manager of each pharmacy within the GPP pharmacy chain shall directly participate in disseminating information and providing drug counseling to customers. Forms of information dissemination and counseling include:

a. Direct counseling and provision of information at the pharmacy through direct communication with patients or by suitable materials (leaflets, films...);

b. Counseling and provision of information via telephone or email (Email);

c. Organizing specialized seminars on drug usage;

d. Organizing public awareness programs on drugs;

đ. Organizing monitoring and reporting adverse drug reactions to the local Department of Health, Drug Information Center, and Adverse Drug Reaction Monitoring Center.

8. Each pharmacy within the GPP pharmacy chain must display the name and photograph of the Quality Director of the GPP pharmacy chain and the pharmacists managing each pharmacy in an easily observable location.

9. Provisions on drug pricing management:

a. Enterprises organizing the GPP pharmacy chain must comply with the price declaration and display regulations as stipulated in Joint Circular No. 11/2007/TTLT-BYT-BTC-BCT dated August 31, 2007, issued by the Ministry of Health, Ministry of Finance, and Ministry of Industry and Trade, guiding state management of drug prices for human use.

b. Pharmacies within the GPP pharmacy chain must sell at the prices announced by the enterprise.

Article 8. Scope of operations of enterprises with Good Pharmacy Practice (GPP) pharmacy chains

1. Retailing finished pharmaceutical products: registered drugs, unregistered drugs, rare drugs for treatment purposes, and compounded drugs based on prescriptions (if there is a compounding area).

2. Importing drugs to serve the activities of the entire GPP pharmacy chain and supply the market.

3. Being prioritized in participating in national drug tendering to provide drugs for hospitals using state budget funds.

4. Supplying drugs for national health target programs in accordance with relevant regulations.

5. Supplying drugs to medical insurance beneficiaries in accordance with relevant regulations.

6. Enterprises with a chain of ten or more GPP-certified pharmacies may purchase drugs from foreign-invested enterprises that have the right to import and export drugs for retail sale within the GPP pharmacy chain and for other business activities.

7. GPP pharmacy chain:

a. Receiving technical documentation related to specialized management work.

b. Being invited to attend relevant seminars.

c. Printing the phrase "GPP-compliant" on signs, counters, shelves, and drug packaging.

d. Participating in promotional programs for GPP principles and standards organized by the Ministry of Health and local Health Departments.

đ. Expanding the scope and target customers of business activities in accordance with the provisions of the Ministry of Health and related regulatory documents.

Chapter III

EFFECTIVE DATE

Article 9. Implementation Organization

1. Application dossier for obtaining the Certificate of Eligibility for Pharmaceutical Business of each pharmacy in the GPP pharmacy chain as stipulated in Clause 1, Article 28 of Decree 79/2006/NĐ-CP.

2. An enterprise ensuring all conditions of the GPP pharmacy chain under this Circular does not need to reapply for the Certificate of Eligibility for Pharmaceutical Business for each pharmacy in the chain if the certificate is still valid.

3. When an enterprise meets the conditions to establish a GPP pharmacy chain as stipulated in this Circular, the enterprise submits a declaration dossier to the Ministry of Health (Drug Administration Department) and the local Health Department where the headquarters is located regarding the organization of the GPP pharmacy chain.

The declaration dossier includes:

- A declaration of the establishment of the GPP pharmacy chain by the enterprise (Form 1).

- Decision appointing the Quality Director.

- Certified true copies of the GPP Certificates, Certificates of Eligibility for Pharmaceutical Business of each pharmacy in the GPP pharmacy chain, and the GDP Certificate of the enterprise organizing the GPP pharmacy chain.

- Photocopies of the GSP certificates of the enterprise.

- Report on the unified quality system as stipulated in Clause 3, Article 3, Chapter I of this Circular (organizational structure, description of functions and responsibilities of the Quality Director and the professional manager of each pharmacy).

4. Enterprises already having a GPP pharmacy chain:

a. In case of expanding the number of pharmacies in the existing chain, within 10 days after being recognized as an additional GPP-compliant pharmacy, the enterprise must submit a report to the Ministry of Health (Drug Administration Department) and the local Health Department where the headquarters is located, along with certified true copies of the GPP Certificate, Certificate of Eligibility for Pharmaceutical Business of the new facility, and a supplementary report on the quality system at the new facility.

b. In case of reducing the number of pharmacies in the existing chain, within 10 days after ceasing operations of a pharmacy, the enterprise must submit a report to the Ministry of Health (Drug Administration Department) and the local Health Department where the headquarters is located.

5. Within 30 days from receiving the declaration dossier of the enterprise organizing the GPP pharmacy chain, the Ministry of Health (Drug Administration Department) issues a Declaration Certificate of the Enterprise Organizing the GPP Pharmacy Chain (Form 2): one copy sent to the enterprise, one copy sent to the local Health Department where the headquarters is located, and one copy retained at the Drug Administration Department.

In case the declaration dossier does not meet the requirements stipulated, the Ministry of Health (Drug Administration Department) will notify the enterprise organizing the GPP pharmacy chain in writing and specify the reasons. If the enterprise fails to complete the dossier within three months from the date of the Drug Administration Department's letter, it must resubmit the declaration dossier from the beginning.

In case changes in organizational structure, management, and operation in the GPP pharmacy chain cause the enterprise to no longer comply with the provisions of this Circular, the Ministry of Health (Drug Administration Department) will revoke the Declaration Certificate of the Enterprise Organizing the GPP Pharmacy Chain.

2. During implementation, if there are any difficulties, units and individuals should submit their opinions in writing to the Ministry of Health (Drug Administration Department) for consideration and resolution./.

Article 10. Effective Date

1. This Circular shall take effect 45 days from the date of signature.

2. During the implementation process, if there are any difficulties, units and individuals are requested to submit their comments in writing to the Ministry of Health (Medicine Administration Department) for consideration and resolution./.