Decision No. 500-BYT/QD Issuing the "Regulation on Pharmaceutical Practice at Pharmacies"

 

Pursuant to …;

REGARDING THE ISSUE OF THE "REGULATIONS ON PHARMACEUTICAL PRACTICE AT PHARMACIES"

THE MINISTER OF HEALTH

Pursuant to Decision No. 153/CP dated October 5, 1961 of the Council of Ministers stipulating the tasks and authorities of the Ministry of Health and Decision No. 196/HDBT dated December 11, 1989 of the Council of Ministers stipulating the state management functions and responsibilities of ministries;
Pursuant to Article 38 of the Law on People's Health Protection;
Pursuant to Decision No. 66/HDBT dated March 2, 1992 of the Council of Ministers regarding individuals and groups conducting business with capital lower than the statutory minimum capital specified in Decision No. 221/HDBT dated July 23, 1991;
At the proposal of the Director of the Drug Management Department;

Pursuant to …;

Article 1: Now hereby promulgates the attached decision "Regulations on Pharmaceutical Practice at Pharmacies".

Article 2: This Decision takes effect from the date of signature and replaces Decision No. 94/BYT-QD dated March 8, 1989.

Article 3: The Heads of the Office, Directors of Departments managing Drugs, Health Management, Environmental Sanitation, Traditional Medicine, General Director of VN National Institute of Hygiene and Epidemiology, Directors of Provincial Health Services under central cities shall be responsible for implementing this Decision.

 

REGULATIONS

PHARMACEUTICAL PRACTICE AT PHARMACIES
(Attached to Decision No. 500/BYT-QD dated April 10, 1992)

Medicines are special goods directly related to the health and lives of users. Based on Decision No. 66/HDBT dated March 2, 1992 of the Council of Ministers regarding individuals and groups conducting business with capital lower than the statutory minimum capital specified in Decision No. 22/HDBT dated July 23, 1991, the Ministry of Health stipulates specific provisions on the organization and operation of pharmacies. A pharmacy is a private retail outlet for medicines.

PART I
CONDITIONS FOR OPENING A PHARMACY

Article 1:ELIGIBLE OBJECTS TO OPEN A PHARMACY

1- Must be a licensed pharmacist.

2- Licensed pharmacists holding the following positions may not apply for registration to open a pharmacy: Director, Deputy Director of the Drug Management Department, Director, Deputy Director of the Testing Institute, Director, Deputy Director of Provincial Health Services, Director, Deputy Director of pharmaceutical enterprises, Chief Inspector, Deputy Inspector, Drug Inspector, Head, Deputy Head of Testing Stations, personnel responsible for drug operations at provincial health services.

Article 2:LICENSED PHARMACIST'S QUALIFICATIONS AS THE PHARMACY OWNER

- Having practiced pharmacy for five years.

- Being in good health.

- Having permanent residence registration in the locality where the pharmacy is to be opened.

- Not being pursued for criminal responsibility.

Article 3:PHYSICAL FACILITIES AND MEDICINE STORAGE REQUIREMENTS

1- Having a fixed location, a separate room with sufficient conditions for storing and selling medicines, ensuring cleanliness, neatness, and tidiness.

2- Displaying signs as prescribed (Annex 4).

3- Medicines must be stored according to professional regulations, protected from factors that affect medicine quality such as sunlight, heat, humidity... Medicines in the counter or cabinet must be arranged in alphabetical order A, B, C or by disease category or dosage form... to avoid confusion and facilitate control.

Article 4:QUALIFICATIONS OF MEDICINE SALESPERSONS

- Must have a diploma in Pharmacy Technician, Intermediate Pharmacy Technician, or Intermediate Pharmacist.

- Being in good health.

- Not being pursued for criminal responsibility.

Article 5:PROFESSIONAL ACTIVITY REQUIREMENTS

1- Personal hygiene.

2- Wearing a clean white coat, neatly, and wearing a badge (with photo, name, position issued by the Provincial Health Service) on the left chest.

3- Checking prescriptions before selling, especially those that must be sold by prescription. Before delivering medicines to patients, the names, concentrations, quantities, and dosages must be verified. Prescriptions for controlled substances must be recorded and stored according to regulations. Medicines given to patients must be carefully packaged, with packaging clearly labeled with the name, concentration, quantity, and address of the pharmacy for easy verification.

4- A pharmacist must be present when the pharmacy is operating.

5- The pharmacy must open and close at the hours posted.

Article 6:The pharmacy can only sell retail medicines that are legally circulating and common medical devices.

Article 7:The pharmacy is not allowed to buy or sell:

1- Raw materials for manufacturing modern drugs.

2- Chemicals for testing.

3- Narcotic drugs.

5- Unregulated domestic medicines.

6- Medicines that do not meet quality standards, have expired, lack proper labeling, do not have registration numbers, or have unclear origins.

 

PART II
PROCEDURES FOR ISSUING A LICENSE TO PRACTICE PHARMACY
PRIVATE PHARMACIST (LICENSE TO PRACTICE PHARMACY)

 

Article 8:The Ministry of Health authorizes the Director of the Provincial Health Service to issue a license to practice pharmacy privately, after which the applicant proceeds to apply for a business permit in accordance with Decision No. 66/HDBT dated March 2, 1992 of the Council of Ministers.

Article 9:The Review Board at the Provincial Health Service:

- One leader of the Provincial Health Service as chairman.

- A pharmacist responsible for pharmacy operations as a standing member.

- The head or deputy head of the testing station as a member.

- May include one or two additional pharmacy specialists.

Article 10:APPLICATION DOCUMENTS FOR A LICENSE TO PRACTICE PHARMACY PRIVATELY:

1- Application for opening a pharmacy.

2- Certified copy of the pharmacist's degree.

3- Curriculum vitae certified by the relevant authority or local government.

4- Location declaration form for opening a pharmacy (if renting, there must be a commitment letter between the lessee and lessor for at least one year).

Article 11:Upon receiving complete applications, the Provincial Health Service must review, inspect, and respond to the applicant within thirty days. If a license to practice pharmacy privately is not granted, the reasons must be clearly explained.

Article 12:A license to practice pharmacy privately is valid for two years; two months before expiration, the holder must apply for a new license.

Article 13:In case the owner pharmacist dies or due to health reasons cannot continue, the heir may borrow a licensed pharmacist who meets the requirements set out in Article 2 to manage the pharmacy for up to six months to sell off remaining stock.

Article 14:The owner pharmacist may request to change the pharmacy location with a minimum period of one year from the date of issuance of the license to practice pharmacy privately or approval of the Provincial Health Service regarding the location. When requesting a change of location, a formal application must be submitted to the Provincial Health Service. If approved, the Provincial Health Service must provide a written response.

Article 15:Upon submission of the application, the applicant must pay a fee as stipulated by the Provincial Health Service. For requests to change location or renew the license to practice pharmacy privately, it will be considered a new review process.

 

CHAPTER III
RIGHTS AND OBLIGATIONS OF THE PHARMACIST OWNING THE PHARMACY (OWNER)

 

Article 16:The pharmacist owning the pharmacy has the right:

1- To be treated equally with other economic entities in the field of pharmacy.

2- To refuse to sell prescriptions that do not comply with professional regulations.

3- To hire salespersons who meet the qualifications specified in Article 4.

4\. Be authorized to delegate another qualified DSDH, as stipulated in Article 2, to substitute for themselves during absence ranging from two days to one month, and must report in writing to the Department of Health beforehand. If the absence exceeds one month, a written application for permission from the Department of Health must be submitted and approved in writing by the Department of Health.

Article 17: The owner pharmacist has the obligation:

In addition to the provisions set forth in Article 17 of Decree No. 66/HĐBT dated March 2, 1992, issued by the Council of Ministers, the owner pharmacist also has the following obligations:

1\. To uphold medical ethics in promoting, advertising drugs, and guiding patients to use drugs reasonably and safely.

2\. To fully implement the prescription drug sales regulations and other professional regulations on pharmacy, maintain accurate record-keeping as prescribed, and possess necessary professional materials such as the Pharmacy Regulations, drug usage guidelines...

3\. To participate in implementing the essential drug program and urgent healthcare needs.

 

PART IV
INSPECTION AND VIOLATION HANDLING

Article 18: The owner pharmacist is subject to inspection and audit under current pharmacy regulations.

Article 19: Violation handling.

The Certificate of Ownership will be revoked:

1\. When the pharmacy purchases, sells, or stores counterfeit drugs.

2\. The owner pharmacist leases, lends, or transfers the Certificate of Ownership.

In addition to the above provisions, depending on the severity of the violation of the regulations, the owner pharmacist will be dealt with according to current regulations.

 

CHAPTER V
IMPLEMENTING PROVISIONS

 

Article 20: This regulation shall take effect from April 10, 1992.

Previous regulations concerning private pharmacies are hereby abolished.