The permit of pharmaceutical trading

A pharmaceutical trading is one of the conditional businesses, the enterprises must apply for an operation license and GDP and GPP standard license at the Department of Health in accordance with the law in order to run business. Procedures for obtaining GDP and GPP standard license is relatively complicated, VLC provides the support services for enterprises to carry out procedures for applying for licenses in accordance with current regulations.

I. Application of GPP license - Retail of medicine, pharmaceutical product:    

1/ Customer are advised to provide the following documents to complete the work file:

No.

Document Name

Quantity

Specification

01

 A pharmacy practice certificate – university level;

02

 The notarized copy within 3 months

02

 ID card + a family book of the practitioner

02

The notarized copy within 3 months

03

The business registration certificate;

02

The notarized copy within 3 months

04

 An organizational chart and staff of the establishment;  

02

 Customers provide information

05

Location map and design of the warehouse;

02

Customers provide information

06

The list of employee (if any)

01

Customer lists in VLC form

07

 The list of equipments

01

 Customer lists in VLC form

08

 Degrees of employees on the list (if any)

01

 The notarized copy within 3 months

2/. Note:

- The implementation period:  30 - 45 working days.

- The validity of the GPP certificate is 3 years

3/. About the necessary facilities:

  1. The minimum area: 10m2
  2. Cabinets, shelves depending on the size of drugstore (VLC will give advice specifically after signing contract and surveying);
  3. Air conditioners, glass doors;
  4. The hand washing area;
  5. The counseling table of pharmacist;
  6. Drugstore
  7. Thermometer, hygrometer.

II. Application of GDP license - Wholesale of medicine, pharmaceutical product:

1/ Customer are advised to provide the following documents to complete the work file:

No.

Document Name

Quantity

Specification

01

 A pharmacy practice certificate – university level;

02

 The notarized copy within 3 months

02

 ID card + a family book of the practitioner

02

The notarized copy within 3 months

03

 The business registration certificate;

02

The notarized copy within 3 months

04

 An organizational chart and staff of the establishment; 

02

 Customers provide information

05

 Location map and design of the warehouse;

02

 Customers provide information

06

 The pharmacist's high school diploma of storekeeper

02

The notarized copy within 3 months

2/. Note

- Duration:  30 - 45 working days from the date of complete documents.

- The validity of the GDP certificate is 2 years, then it will be re-examined and renewed 01year / a time.

- After signing the contract, VLC staff will come to survey the location of the business to check and give advice for your enterprise.

3/. About the necessary facilities

- Preservation area of drug: The minimum area is 30 m3; the minimum capacity is 100m3

- Equipping with the appropriate shelves system. The distance between the warehouse floor and the shelves containing drug should be large enough for easy cleaning and drug inspection.

- For the establishments of distributing vaccines and bio-health products, it must be established a cold chain system (cold chain) (including cold storage, portable refrigerators, and cold vehicles, etc.)

4./ Personnel

- The drug storekeeper must have the qualification from middle class pharmacists or more. For the herbal medicine distributors, the storekeeper must have the qualification frommiddle class of traditional medicine or herbalist or more. For the drug distribution establishments required for special management (narcotics, psychotropic drug and substances used as drug), the storekeeper must meet the provisions in the relevant regulations.

- Personnel of inspecting, controlling drug quality must have the qualification of university-pharmacist.

- For the establishments of distributing vaccines and bio-health products, the storekeeper must have the qualification from the medical-pharmaceutical intermediate or more; employees who are responsible for transportation must have qualification in pharmacy from high school or more; the staffs on duty of delivery must have qualification from medical-pharmaceutical primary or more.

- The employees must ensure their health and must be periodically examined for health. The employees of infectious diseases must be separated from the areas of drug storage, trafficking.

- Developing and implementing the process of personal hygiene for staffs in accordance with the activities conducted. The contents of that process must mention to the issues of health, hygiene, and clothing of staffs.

- Employees participating in drug distribution must wear protective clothing or uniforms properly to the works that they carry out. Employees exposed to hazardous drug (e.g. the products are highly active, toxic, easy to infection or allergens) must be provided necessary protective clothing.

- It must have the procedures and first aid equipment to tackle the accidents that could happen affecting the safety of employees.

 

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