Circular No. 43/2010/TT-BYT stipulates the implementation timeline for the "Good Pharmacy Practice" (GPP) principles and standards; geographical areas and scope of operation for retail drug establishments.

CIRCULAR

Specifies the implementation timeline for the "Good Pharmacy Practice" GPP principle and standards; geographical area and scope of operation of retail drug outlets

Implementation timeline for the "Good Pharmacy Practice" GPP principle and standards; geographical area and scope of operation of retail drug outlets

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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 the Drug Law No. 34/2005/QH11 dated June 14, 2005;

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

The Ministry of Health stipulates the implementation timeline for the "Good Pharmacy Practice" GPP principle and standards; geographical area and scope of operation of retail drug outlets:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the implementation timeline for the "Good Pharmacy Practice" GPP (hereinafter referred to as GPP) of pharmacies, drug counters; geographical areas for opening drug counters, drug agents of enterprises, and medicine cabinets of health stations, and the scope of operation of retail drug outlets.

This Circular applies to organizations and individuals related to drug business activities, retail formats, within Vietnam.

Article 2. Interpretation of Terms

1. Retail drug outlet means pharmacy, drug counter, drug agent of an enterprise, medicine cabinet of a health station, and specialized retail outlets exclusively selling traditional Chinese medicine and herbal drugs.

2. Retail drug outlet in hospitals refers to retail drug outlets within hospital premises organized in the forms of pharmacy, drug counter, or specialized retail outlets exclusively selling traditional Chinese medicine and herbal drugs.

3. Pharmacy in medical examination and treatment facilities (except in cases provided for in Clause 2 of this Article) is a pharmacy operating within the premises of medical examination and treatment facilities.

4. Finished drug product is a form of drug that has undergone all stages of production, including final packaging and labeling.

5. Herbal drug is a drug produced from natural raw materials of animal, plant, or mineral origin. Drugs with active ingredients extracted from herbs combined with synthetic chemical substances are not considered herbal drugs.

6. Traditional Chinese medicine is a herbal drug prepared according to the theory and methods of traditional Eastern medicine.

Chapter II

IMPLEMENTATION TIMELINE FOR GPP AT PHARMACIES, DRUG COUNTERS AND GEOGRAPHICAL AREAS FOR OPENING DRUG COUNTERS, DRUG AGENTS OF ENTERPRISES, AND MEDICINE CABINETS OF HEALTH STATIONS

Article 3. For the pharmacy format

1. Hospitals' pharmacies, pharmacies in medical examination and treatment facilities, and pharmacies selling addictive drugs must meet GPP.

2. Pharmacies in the wards of four (04) cities: Hanoi, Ho Chi Minh City, Da Nang, and Can Tho must meet GPP.

3. Newly established pharmacies must meet GPP.

4. Existing pharmacies or pharmacies renewing, extending, or reissuing the Drug Business Conditions Certificate if they have not met GPP except in cases provided for in Clause 1 and Clause 2 of this Article may continue operations until December 31, 2011.

Article 4. For the drug counter format

1. Hospital drug counters must meet GPP.

2. Operating drug counters in wards of districts, towns, provincial cities, or drug counters renewing, extending, or reissuing the Drug Business Conditions Certificate in wards of districts, towns, provincial cities must meet GPP.

3. All drug counters must meet GPP as of January 1, 2013.

Article 5. Locations for pharmacies, drug retail outlets of enterprises, and medicine cabinets of health stations

1. Pharmacies, drug retail outlets of enterprises, and medicine cabinets of health stations may be established in communes and towns under districts, counties, and provincial cities. If a commune or town already has a sufficient number of retail drug outlets to serve 2000 residents, no new drug retail outlets of enterprises shall be established.

2. For wards under districts, towns, and provincial cities that have not yet reached having one pharmacy or drug counter to serve 2000 residents, enterprises with a GSP warehouse (if there is no enterprise meeting GSP standards in the province, enterprises meeting GDP standards will be allowed) may continue to establish new drug counters meeting GPP standards in the wards of districts, towns, and provincial cities.

4. Drug retail outlets of enterprises currently operating in wards under districts, towns, and provincial cities may continue to operate until December 31, 2011, if there are not enough pharmacies or drug counters serving 2000 residents in those areas.

Chapter III

SCOPE OF OPERATIONS OF RETAIL DRUG OUTLETS

Article 6. Scope of operations of pharmacies

1. Pharmacies meeting GPP standards may sell finished drugs; compound drugs according to prescriptions (if there is an arrangement for compounding according to prescriptions).

2. Pharmacies not meeting GPP standards are only permitted to sell over-the-counter drugs listed in the Catalogue of Non-Prescription Drugs issued together with Circular No. 08/2009/TT-BYT dated June 1, 2009, of the Ministry of Health.

3. In areas where there are no pharmacies meeting GPP standards but need to set up points for selling addictive drugs, the Department of Health shall designate pharmacies to sell addictive drugs.

Article 7. Scope of operations of drug counters

1. Drug counters meeting GPP standards may sell finished drugs.

2. In cases where drug counters belonging to enterprises are currently selling addictive drugs, they must meet GPP standards to continue being authorized to sell addictive drugs.

3. Drug counters not meeting GPP standards are only permitted to sell over-the-counter drugs listed in the Catalogue of Non-Prescription Drugs issued together with Circular No. 08/2009/TT-BYT dated June 1, 2009, of the Ministry of Health.

Article 8. Scope of operations of drug retail outlets of enterprises, medicine cabinets of health stations, and specialized retail outlets for traditional Chinese medicine and herbal drugs

1. Drug retail outlets of enterprises may sell essential drugs (excluding addictive drugs, psychotropic drugs, and precursor chemicals used in drugs and prescription drugs).

2. Medicine cabinets of health stations may sell essential drugs listed in the Essential Drugs Catalogue for Tier C (excluding addictive drugs, psychotropic drugs, and precursor chemicals used in drugs and prescription drugs).

3. Specialized retail outlets for traditional Chinese medicine and herbal drugs may sell traditional Chinese medicine and herbal drugs.

Chapter IV

IMPLEMENTATION

Article 9. Transitional Provisions

For retail drug outlets still within the validity period of their certificates of qualification for drug business or at the time of renewal, change, or reissue of certificates, but must change their scope of business due to not meeting GPP standards, they must operate in accordance with the prescribed scope of business for outlets not meeting GPP standards or cease operations within three months from the date this Circular takes effect; the Department of Health shall issue a notice regarding the operation period (if the certificate is still valid) or extend, change, or reissue the certificate according to the schedule stipulated in Chapter II of this Circular.

Article 10. Issuance of Certificates and Supervision of Retail Drug Outlets

1. The Drug Administration Department shall develop and promulgate a list of criteria for GPP inspections based on the Principles and Standards for Good Pharmacy Practice issued together with Decision No. 11/2007/QĐ-BYT dated January 24, 2007, of the Minister of Health, to suit the implementation of GPP nationwide.

2. The Department of Health shall accept and review applications for inspection registration, form inspection teams for establishments, and issue certificates of compliance with Good Pharmacy Practice standards for operating establishments or re-evaluate GPP, while issuing Certificates of Qualification for Drug Business for newly established establishments.

3. Certificates of compliance with GPP Principles and Standards are valid for three years from the date of issuance. Certificates previously issued with a two-year validity period may be extended for an additional year from the expiration date, and the Department of Health shall issue decisions on extension accompanied by lists of establishments extending their GPP Compliance Certificates.

4. During the validity period of the Certificate of Compliance with GPP Principles and Standards, if any non-compliance issues are discovered during inspections, supervision, and monitoring, the Department of Health shall advise and require the retail drug outlet to take corrective measures in the Inspection Report or through a letter.

In cases where retail drug outlets violate regulations during business operations or no longer meet the conditions for recognition of GPP compliance, the Department of Health shall apply one or more of the following measures depending on the severity of the violation:

- Notify relevant units about the failure to maintain GPP conditions (notify the enterprise if it is a branch or business location of the enterprise, notify professional associations...).

- Impose administrative penalties according to regulations for violations specified in the provisions on administrative penalties in the pharmaceutical sector.

Chapter V

EFFECTIVE DATE

Article 11. Effective Date

1. Repeal Clause 5, Part II of Circular No. 02/2007/TT-BYT dated January 24, 2007, guiding detailed implementation of certain provisions on drug business conditions.

2. This Circular takes effect 45 days from the date of issuance./.