Circular No. 48/2011/TT-BYT Issuing the "Good Distribution Practice for Medicinal Products" Principles

CIRCULAR

Issuing the "Good Distribution Practices for Drug Distribution" principles

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Pursuant to the Medicine Law No. 34/2005-QH-11 dated June 14, 2005;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the 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 Medicine Law,

The Ministry of Health issues the "Good Distribution Practices for Drug Distribution" principles as follows:

Article 1. Scope of application

The "Good Distribution Practices for Drug Distribution" principles issued together with this Circular apply to entities participating in the drug distribution process on the territory of Vietnam, including production facilities, including intermediate product manufacturing facilities, finished drug manufacturing facilities, supply facilities, import-export, distribution, wholesale, transportation facilities, delivery agents, central storage and distribution facilities for national health programs.

Article 2. Interpretation of Terms

The terms used in this Circular shall be understood as follows:

1. GDP stands for Good Distribution Practices - Good Distribution Practices for Drug Distribution.

2. Drug distribution refers to the division and movement, storage of drugs from the warehouse of a drug manufacturing facility or a distribution center to the end user or to intermediate storage and distribution points or between such intermediate storage and distribution points by different means of transport.

3. Quarantine storage refers to the condition where drugs are kept separately in an isolated area or by administrative measures pending a decision to allow entry into or exit from the warehouse for compounding, packaging, distribution, or destruction.

Article 3. The initial inspection application file for the "Good Distribution Practices for Drug Distribution" principle shall be compiled into a set, including:

1. Application form for inspection of "Good Distribution Practices for Drug Distribution" (Form No. 1/GDP);

2. A copy of the establishment permit for the facility or business registration certificate or investment certificate (certified true copy or signed and stamped confirmation by the facility);

3. Organizational chart of the facility (including: human resources organization, distribution system organization (facility, branch, warehouse, agent)). The chart must clearly show the name, position, and professional qualifications of key staff members of the facility and its affiliated units;

4. Geographic location map and design of the drug storage warehouse;

5. List of equipment for storage, transportation, and distribution of the facility. In cases where drug transportation is carried out under a contract, there must be documentation introducing the legal entity, equipment, and transportation and storage means of the contracting party.

Article 4. The re-inspection application file for "Good Distribution Practices for Drug Distribution" shall be compiled into a set, including:

1. Re-inspection application form according to the "Good Distribution Practices for Drug Distribution" principle (Form No. 2/GDP);

2. Report on changes at the facility during the three years of implementing "Good Distribution Practices for Drug Distribution" and related documents, if any;

3. After submitting the re-inspection application, the facility may continue to operate within the scope specified in the previously issued "Good Distribution Practices for Drug Distribution" certification and the valid drug business qualification certificate.

Article 5. The application file for inspection of the "Good Distribution Practices for Drug Distribution" principle, in cases of change or addition to the business scope, or change in business or storage location, shall be compiled into a set, including:

1. Application form for inspection of changes or additions to the "Good Distribution Practices for Drug Distribution" certification (Form No. 3/GDP);

2. Organizational chart of the facility (including: human resources organization, distribution system organization (facility, branch, warehouse, agent)). The chart must clearly show the name, position, and professional qualifications of key staff members of the facility and its affiliated units;

3. Geographic location map and design of the warehouse;

4. List of equipment for storage, transportation, and distribution of the facility. If drug transportation is carried out under a contract, there must be documentation introducing the legal entity, equipment, and transportation and storage means of the contracting party;

Article 6. Inspection Authority and Composition of the Inspection Team

1. Inspection Authority and Issuance of Certificates

The Department of Health of provinces and centrally governed cities (referred to as the Department of Health) shall be responsible for receiving applications, reviewing applications, establishing inspection teams, conducting on-site inspections, and issuing the Certificate "Good Distribution Practice for Pharmaceutical Products".

2. Standards for Inspectors of "Good Distribution Practice for Pharmaceutical Products"

a) The head of the inspection team must have a bachelor's degree in pharmacy and at least two years of experience in pharmaceutical management.

b) Members of the inspection team must hold a bachelor's degree or higher.

3. Composition of the Inspection Team: It includes the head of the team, a secretary, and other members determined by the Director of the Department of Health.

Article 7. Procedures for Registration, Inspection, and Recognition of Compliance with GDP

1. After self-inspection and evaluation showing compliance with "Good Distribution Practice for Pharmaceutical Products", entities shall submit an application for inspection of "Good Distribution Practice for Pharmaceutical Products" to the Department of Health where the drug storage facility is located.

2. Departments of Health shall issue and follow procedures for issuing certificates of compliance with "Good Distribution Practice for Pharmaceutical Products", ensuring the following principles:

a) Within fifteen days from the date of receipt of the request for recognition of compliance with "Good Distribution Practice for Pharmaceutical Products", the Department of Health shall establish an inspection team and conduct an inspection at the entity (according to the Checklist in Appendix I).

b) The Department of Health shall issue the Certificate "Good Distribution Practice for Pharmaceutical Products" to the entity within five working days from the end of the satisfactory inspection; or within ten working days from the date the Department of Health receives the report on corrective actions for deficiencies noted in the inspection record.

c) In cases requiring re-inspection, within ten working days from the date of receipt of the report on corrective actions and the request for re-inspection from the entity, the Department of Health shall conduct the re-inspection.

3. The inspection record must be signed and confirmed by the professional manager and the head of the inspection team, made into two copies: one copy retained by the entity, and one copy retained by the Department of Health of the province or centrally governed city where the entity operates. (Form No. 4/GDP).

Article 8. Validity Period of the Certificate "Good Distribution Practice for Pharmaceutical Products"

The Certificate "Good Distribution Practice for Pharmaceutical Products" (Form No. 5/GDP) has a validity period of three years from the date of issuance. Certificates issued previously with a validity period of two years will continue to be valid for an additional year from the expiration date. The Department of Health shall issue a Decision extending the validity period along with a list of entities whose certificates "Good Distribution Practice for Pharmaceutical Products" are extended.

Article 9. Effective Date

This Circular takes effect from February 5, 2012, and replaces Decision No. 12/2007/QD-BYT dated January 24, 2007, regarding the issuance of "Good Distribution Practice for Pharmaceutical Products" and related contents in Decision No. 29/2007/QD-BYT dated May 11, 2007, concerning amendments and supplements to certain provisions of Decision No. 12/2007/QD-BYT.

During implementation, if there are difficulties or obstacles, units are requested to promptly reflect them to the Drug Administration - Ministry of Health for research and appropriate amendments and supplements./.