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Importing, exporting and trading service on preservation of medicines and medicinal row materials is a conditional business of storage warehouses.

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The Ministry of Health has issued Circular 36/2018/TT-BYT, effective from January 10, 2019, on Good Storage Practices for medicines and medicinal materials, including pharmaceutical chemical materials, medicinal materials and traditional medicines (referred to as GSP).

Subjects to application of GSP: Import and export establishments; Establishments providing preservation services for medicines, pharmaceutical chemical materials, medicinal materials and traditional herbs; Drug and vaccine storage warehouses of health facilities, national health programs and of People's Armed Forces.

Establishments in compliance with GSP regulations according Circular 36/2018/TT-BYT have the right to import drugs and medicinal materials but are not allowed for drugs distribution in Vietnam. They can only export and deliver goods to drug and medicinal material wholesale facilities at the facility's storage warehouse.

If an establishment, that has GSP-compliant storage warehouse, wants to perform the function of distributing medicines and medicinal materials, so the way is to registration for Good Distribution Practices (GDP) certificate for medicine and medicinal materials, without the need of upgrade the infrastructure, just adding the necessary procedures and equipment for the distribution service.

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5 Notes for GSP Warehouse Investment


1. The warehouse must be built firmly. The ceiling, wall, and floor of the warehouse must ensure specific conditions to prevent the outside bad influences such as: weather fluctuations, harmful animals, ...

2. The warehouse must ensure the area, lighting, equipment, and appropriate storage areas to guarantee that the activities taking place at the warehouse are accurate, safe and effective. Enough signs indicating each areas in the warehouse is also required in accordance with regulations.

3. The activities taking place at the warehouse must be carried out in accordance with the standard issued rules, regulations and procedures, and must be always recorded and saved to ensure the quality of goods stored in the warehouse.

4. Storage conditions (temperature, humidity) must be strictly controlled according to regulations.

Regulations that GSP warehouses need to comply with?

GSP Warehouse Documents including:

5. Documentation 
6. Storage
7. Handling complaints and product recalls
8. Self-inspection
1. Site master file of facility
2. Quality Control System
3. Personnel
4. Facility and Equipment

Necessary informations about GSP regulations for 
Medicines, Medicinal materials warehouse & Medicinal herbs, traditional medicines warehouse

Medicines, Medicinal materials warehouse

Medicinal herbs, traditional medicines warehouse

Items

Circular 36/2018/TT-BYT/ Appendix I

Circular 36/2018/TT-BYT/ Appendix II

Drug Administration of Vietnam - Ministry of Health

Traditional Medicine Administration - Ministry of Health

>= 300m2 (following experience of consultant)

>= 500m2/ 1500m3 (Requirements of Regulatory Authority)

> 3 billion VND with minimum scale

> 3 billion VND with minimum scale

Normal conditions: temperature from 15-30°C, humidity <= 75%
Special conditions: depending on product requirements

Dry, airy conditions: temperature from 15-25°C, relative humidity not more than 70%

3 years

3 years

3 months in total (already had emty facility)

3 months in total (already had emty facility)

1. Legal basis

3. Minimum surface area 

2. Issuing authority

4. Investment capital scale

5. Storage conditions

6. Validity of certificates

7. Deployment time

Sample Project - 3D Models GSP Warehouse 

Sign up for more consultation

  • Minimum project scale: 1100m2 
  • Minimum project requirement: 300 - 400m2 
  • GSP Authority: Drug Administration - Ministry of Health

PROCEDURE & SERVICE PACKAGES

Request for quotation

G03. Construction Management and Supervision 

  • Send qualified personnel to preside, or collaborate with investor's personnel in order to Manage and Supervise the project construction.
  • Manage and Supervise the construction contractor to ensure: Quality, Progress, Cost, Construction Safety in accordance with Design and Contract.

G01.  Preliminary-Overall Consultancy

  • Total investment amount? Project implementation time?
  • Site Master Planning, Site layout design of warehouse?
  • Master Plan, with clear description of works?
  • Make responsibility to the results of the project?
  • List of required legal procedures before starting implementation.

G02. Project Construction Drawings Design

  • Detailed design (renovation/new construction) for the Warehouse and auxiliary items.
  • Detailed MEP system design: HVAC system, Electricity system, Extra-low voltage system, Panel, Floor Paint, Shelves, BMS, ...
  • Detailed Budgeting (Equipments/Supplies, Quantity, Unit Price, Total Cost)
  • Ensuring the Design dossier and Budgeting are clear and objective, it can be used as STANDARD for competitive bidding between contractors.

G04. Training - Drafting registration dossier

  • GMPc's Training service is Creative, Professional, especially Effective, focus on Practices guidance combining with Theoretical training (Training on job)
  • Directly Guide to Draft and Finalize the registration dossier for GSP/ Eligibility for pharmaceutical business conditions in compliance with DAV requirements
  • Ensuring your workforce will confidently answer and defense to the GSP inspection team, as well as be equiped the GSP knowledge and practical skills to take control the operation of storage warehouse in compliance with GSP regulations.

GA. Turnkey Consulting Service A-Z

  • Most of project investors choose GMPc as turnkey consultant (A-Z) because this option brings the most optimal effect to them.
  • The TURNKEY CONSULTING service including 04 service packages: G01+G02+G03+G04
  • After having the design and detailed budgeting prepared by GMPc, investor has full right to decide appropriate construction contractor and equipment suppliers.
  • Although not being the Construction Contractor, GMPc still willing to take responsibility about the success and guaranteed certification of project.

GE. General Contractor: Design - Construction - Registration for Certificate

  • About 30% investors choose GMPc as General Contractor of Design-Construction-Registration for Certificate.
  • In fact, there are some investors who invested up to 3 facilities, and they consistently choose to cooperate with GMPc under this service package.
  • This package is especially suitable for Investors who have used GMPc's Services, fully understand the value and effectiveness that GMPc has brought to the Project.

About Us

Established since May 25, 2021 GMPc proud to have been the pioneer consultant in providing a comprehensive and turnkey consulting model for GMP-certified facility projects.
Having competent manager, GMP experts and professional team of staff including pharmacists, engineers, chemists,..with several years experiences on GMP practices at large-scales factories, we have always been dedicating ourselves into each commissioned project while adhering to the core value of Get GMP – Get what you want!
GMPc has been trusted by most nationwide investors with over 200 GMP-certified facility projects, which equals to more than 80% market share in Vietnam from 2011 to 2022. Because of customer's faith, we ensure to be always do our best to create and contribute the consulting solutions that Simplification - Cost Optimization - Guaranteed Certification on the basis of understanding the needs and differentiation strategy of each customer.

+11 

years
experience

Branch
Hanoi & HCM City

Projects
GMP facility

+200

See more: GMPc capacity profile

Website: www.gmp.com.vn

Why choose GMPc Vietnam?

3 main reasons that influence 80% of Vietnam GMP-project investors choosing GMPc as consultant!

  • The choice of all leading brands: Codupha, Haphaco
  • Success rate of 100%.
  • Satisfied all investors.
  • Highly praised by authorities.

 1. Affirmed Reputation

  • Only one consultant for whole project
  • We get GMP - We get what you want.
  • Detailed implementation plan, indicating all possible options so investor can make the final decision.
  • Single choice to resolve all arising problems

2. Turnkey consulting solution

  • In compliance with GSP regulations; 
  • Meet the Authorities' requirements; 
  • Optimization of investment and operation cost; 
  • Controlled progress; 
  • Certification- success rate of 100% 

3. Taking responsibility

TYPICAL PROJECTS

Address: Le Minh Xuan IP - Binh Chanh District - Ho Chi Minh City

See more:  List of project consulted by GMPc Vietnam (2011-2021)

Hapharco Pharmaceutical Storage Warehouse - GSP certification

Address: Quat Dong IP - Thuong Tin District - Hanoi

Codupha Pharmaceutical Storage Warehouse - GSP certification

Codupha Storage Warehouse - GSP certification


Address: Hoa Cam IP - Cam Le District - Danang

Dapharco Pharmaceutical Storage Warehouse - GSP certification



Address: 02 Phan Dinh Phung St, Hai Chau District, Danang

CUSTOMER'S REVIEW

100% GMPc's customer are satisfied with our services!

"We highly appreciate the capacity of GMPc's design consulting team and already choosed GMPc as Design consultant for GSP-compliant pharmaceutical storage warehouse project. We sincerely thank GMPc and hope you prosperity."

Mr. Tong Viet Phai
General Manager, Danang Pharmaceutical Medical Equipment Joint Stock Company

"The implementation of our Pharmaceutical general storage warehouse project required a reputable partner, that not only have extensive experience in design and construction of GSP warehouse but also is capable to support legal procedures, Training and finalizing GSP registration dossier.
We are impressed with GMPc's turnkey consulting service and satisfied when choosing GMPc as General contractor for our landmark project.
We are looking forward to cooporate with GMPc in upcoming projects."

Mr. Le Van Son 
Board Chairman , CODUPHA Central Pharmaceutical Joint Stock Company
www.codupha.com.vn
Codupha Introduce
www.dapharco.com.vn
Dapharco Introduce

Frequently Asked Questions (FAQ)?

We are in need of construction a medicinal materials storage warehouse to import (GSP). What is the minimum surface area?

According to the Circular No. 36/2018/TT-BYT, the medicinal material storage warehouses for import must have an area of at least 500 m2 and a minimum capacity of 1500m3. For more informations, refer to Circular No. 36/2018/TT-BYT and Appendix II of this Circular.

Our establishment want to change the location of storage warehouse to same location with business activities. What should to do?

After changing warehouse location, the establishment has to apply for the Certificate of eligibility for pharmacy business or report the change according to Form No. 06 specified in Appendix VII issued with Circular 36/2018/TT-BYT

When do I need to submit registration dossier for re-evaluation of GSP?

At least 30 days before the periodical assessment day of GSP compliant maintenance according to the announced plan. The establishment must send to the Authority a dossier including a report of export and import business activities or medicines, medicinal materials storage services which can proved the GSP compliance status of the storage warehouse.

The standard appraisal fees of GSP for medicine and medicinal materials?

The standard appraisal fees and conditions for medicine and herbal medicinal materials storage (GSP) are specified in the Circular 277/2016/TT-BTC promulgated by the Minister of Finance. The circular stipulating the rate of collection, collection regulations, payment, management and use of fees in the field of pharmaceuticals and cosmetics, specifically: The standard appraisal fees for medicines and herbal medicinal material storage (GSP) is 14,000,000 VND/establishment.

Can a foreign-invested enterprises own a GSP warehouse?

Yes. Foreign-invested enterprises are allowed to own GSP warehouses and are allowed to import medicines and medicinal ingredients, but are not allowed to distribute them.

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Q&A for Foreign-Invested Enterprises

How do foreign-invested pharmaceutical distribution enterprises (such as Zuellig, DKSH,..) run their business?

In fact, in Vietnam, foreign-invested enterprises (Zuellig, DKSH, etc.) can have GSP warehouses and are allowed to self-import. However, in order to facilitate the legal procedures of import, transport and distribution after importing, most medicines and medicinal ingredients are still imported and distributed through Vietnamese companies.
For example: Zuellig imports and distributes via Sang Pharma and Coduphar; DKSH imports and distributes via Vimedimex Binh Duong.

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Can foreign-invested enterprises provide preservation services (Preservation of medicines, medicinal ingredients for partners)?

No. Foreign-invested enterprises are not allowed to provide services of preservation and transportation medicines and medicinal ingredients for their parters. Because these activities are recognized as distribution activities.

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We are a foreign-invested enterprise, we want to invest in GSP warehouse and provide preservation services, how should we do it?

A foreign-invested enterprise are allowed to invest in GSP warehouse with business scope of Importing - Exporting medicines and medicinal ingredients.
If foreign-invested enterprises want to provide preservation services, they have to cooporate with Vietnamese company which have business registration certificate on medicine, medicinal ingredients preservation service.

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Which legislation related to above issues?

- Appendix 3 - Circular 34/2013/TT-BTC
- Law No. 105/2016/QH13 on Pharmacy
- Decree 54/2017/ND-CP
- Official Dispatch 4338/QLD-PCD 2018

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GMPc VIETNAM JOINT STOCK COMPANY
TURNKEY CONSULTING SERVICE FOR GSP PHARMACEUTICAL STORAGE WAREHOUSE - 
GSP HERBS INGREDIENTS STORAGE WAREHOUSE

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