Conditions for establishing a pharmaceutical company in Vietnam

Legal bases

• Pharmacy Law 2016;
• Decree 54/2017/ND-CP stipulates a number of articles and measures to implement the Pharmaceutical Law;
• Decree 155/2018/ND-CP amending and supplementing a number of regulations related to business investment conditions under state management of the Ministry of Health.

What is a pharmaceutical company?

• Pharmaceutical business is the implementation of one, some or all stages of the investment process, from production to consumption of products or provision of services related to drugs and medicinal raw materials on the market for the purpose of profit.
• A pharmaceutical company is a type of company that sells integrated drugs that are researched from different ingredients, verified for quality origin.

Pharmaceutical business

Pharmaceutical business activities include:

• Trading in medicines and medicinal raw materials;
• Trading in services for preserving drugs and medicinal raw materials;
• Provision of drug testing services and medicinal raw materials;
• Business in clinical drug testing services;
• Business in bioequivalence testing services of drugs.

Pharmaceutical business establishments in Vietnam

Pharmaceutical business establishments include:

• Establishments producing drugs and raw materials for making drugs;
• Establishments exporting and importing drugs and medicinal raw materials;
• Establishments providing services for preserving drugs and medicinal raw materials;
• Wholesale establishments of drugs and medicinal raw materials;
• Drug retail establishments include pharmacies, pharmacy counters, commune health station medicine cabinets, establishments specializing in retailing medicinal herbs, medicinal herbs and traditional medicines;
• Provision of drug testing services and medicinal raw materials;
• Clinical drug testing service providers;
• Business establishments providing bioequivalence testing services of drugs.

Conditions for establishing a pharmaceutical company in Vietnam

Conditions on subjects establishing pharmaceutical companies

All organizations and individuals establishing pharmaceutical companies must satisfy the following conditions:

• Organizations with legal status;
• Individuals from full 18 years old; have full capacity for civil acts;
• Not subject to the State’s prohibition on establishment and management of enterprises as prescribed in Clause 2, Article 17 of the Law on enterprises 2020.
• Managers and heads must have pharmacy practice certificates suitable to the fields in which pharmaceutical companies do business and operate.

Conditions on charter capital

There are no regulations on self-declared company capital and self-responsibility.

Conditions for issuance of the Certificate of eligibility for pharmaceutical business in Vietnam

• Conditions on facilities, techniques and personnel
• The person responsible for pharmacy expertise and job position must have a pharmacy practice certificate appropriate to the pharmacy business establishment.
• The assessment of eligibility for material, technical and personnel facilities shall be carried out every 3 years or irregularly according to regulations of the Minister of Health or treaties to which the Socialist Republic of Vietnam is a contracting party.

Conditions on facilities, techniques and personnel

• Manufacturers of drugs and raw materials for making drugs must have locations, production workshops, laboratories, warehouses for storing drugs, medicinal raw materials, auxiliary systems, equipment, machinery for production, testing and storage of drugs, quality management systems, professional and technical documents and personnel meeting Good Drug Manufacturing Practices, medicinal raw materials;
• Importers of drugs, medicinal raw materials, exporters of drugs, medicinal raw materials, providers of drug storage services and medicinal raw materials must have locations, drug storage warehouses, storage equipment, means of transportation, quality management systems, professional and technical documents and personnel meeting Good storage practices, medicinal raw materials;
• Wholesale establishments of drugs and medicinal raw materials must have locations, warehouses for storing drugs, storage equipment, means of transportation, quality management systems, professional and technical documents and personnel meeting Good Practices for distributing drugs and medicinal raw materials;
• Drug retailers must have locations, storage areas, storage equipment, professional and technical documents and personnel that meet Good Practices of drug retailers; for establishments specializing in retail sale of medicinal herbs, medicinal herbs and traditional medicines shall comply with the provisions of Point b, Clause 2, Article 69 of this Law;
• Establishments providing drug testing services and medicinal raw materials must have locations, chemical, microbiological or biological laboratories, auxiliary systems, testing equipment, chemicals, reagents, quality management systems, professional and technical documents and personnel meeting Good Laboratory Practices for drug quality inspection;
• A provider of clinical drug testing services must have locations, clinical laboratories, laboratories, biochemical testing equipment, quality management systems, professional and technical documents and personnel that meet Good Clinical Testing Practices;
• Drug bioequivalence testing service providers must have locations, biofluid analysis laboratories, laboratory equipment used in biofluid analysis, accommodation and monitoring areas for drug users for bioequivalence assessment, quality management systems, technical professional documentation and personnel meet Good Laboratory Practice for the Biofluid Analysis phase and Good Clinical Drug Trial Practice for the Clinical Research Phase.

In case a drug bioequivalence testing service provider only meets Good Laboratory Practice for biofluid analysis, it must sign a contract or associate with a clinical drug testing establishment that meets Good Clinical Testing Practices to carry out the clinical research phase in the bioequivalence trial of drugs.

Conditions for pharmacy practice certificate

The job position must have a pharmacy practice certificate

• The person responsible for the pharmacy expertise of the pharmaceutical business.
• Persons in charge of quality assurance of drug manufacturers and medicinal raw materials.
• Person in charge of clinical pharmacy work of medical examination and treatment establishments.

Conditions for issuance of the Certificate of Pharmacy Practice

• Possess professional diplomas, certificates and certificates (hereinafter collectively referred to as professional diplomas) granted or recognized in Vietnam suitable to their job positions and pharmaceutical business establishments.
• Having time to practice at pharmaceutical trading establishments, pharmaceutical departments of medical examination and treatment establishments, specialized pharmaceutical training schools, pharmaceutical research establishments, drug testing establishments, medicinal raw materials, drug management agencies or representative offices of foreign traders operating in the pharmaceutical sector in Vietnam (hereinafter collectively referred to as pharmaceutical establishments); medical examination and treatment establishments suitable to the practitioner’s expertise
• Have a certificate of fitness to practice pharmacy issued by a competent medical institution.
• Not being subject to being examined for penal liability, serving judgments or decisions of the Court; during the period of prohibition from practicing, prohibition from doing work related to pharmaceutical activities according to court judgments or decisions or limited capacity for civil acts.
• For those who voluntarily apply for a Certificate of Pharmacy Practice in the form of examination, they must meet the conditions as prescribed above.

Procedures for establishing a pharmaceutical company in Vietnam

Step 1: Prepare documents and submit dossiers for business registration certificates

A dossier of implementation of procedures for establishment of a drug trading company includes:

• Application for business registration;
• Charter of pharmaceutical companies;
• List of members or shareholders of the company (if it is a limited liability company with two or more members or a joint-stock company);
• A valid copy of a valid ID card or valid passport for individuals;
• A copy of the Business Registration Certificate/Business Registration Certificate for the organization (except for cases where the organization is a Ministry / People’s Committee of the province or city) and enclosed with personal identification papers and authorization decisions of the authorized representative of the organization;
• A copy of the decision on capital contribution for members being organizations;
• Power of attorney for Viet An Law.

Step 2: Disclosure of business registration information

After being granted the Certificate of Business Registration, the enterprise must publicly announce on the National Portal on business registration according to the order and procedures and pay fees as prescribed.

Step 3: Procedures after establishing a pharmaceutical company

• Engraving the seal and announcing the seal sample;
• Hang a sign at the company’s headquarters;
• Register a bank account;
• Purchase invoices;
• Pay license fees and charges as prescribed.

Procedures for issuance of the Certificate of eligibility for pharmaceutical business in Vietnam

Step 1: Drafting an application for a Certificate of eligibility for pharmaceutical business

• An application for a Certificate of eligibility for pharmaceutical business;
• Technical documents corresponding to pharmaceutical trading establishments;
• A certified copy of the Certificate of Business Registration or a legal document proving the establishment of the establishment;
• Certified copy of the Certificate of Pharmacy Practice.

Step 2: Apply

The company applying for the Certificate of eligibility for pharmaceutical business submits the application in person or sent by post.

Competent agencies receiving dossiers for issuance of Certificate of eligibility for pharmaceutical business:

• The Ministry of Health shall apply for a Certificate of eligibility for pharmaceutical business in one of the cases specified at Points a, b, c, e, g and h, Clause 2, Article 32 of the Pharmacy Law;
• Provincial-level Health Departments of the localities where such establishments are located in case of application for a Certificate of eligibility for pharmaceutical business fall into one of the cases specified at Points d and dd, Clause 2, Article 32 of the Pharmacy Law.

Step 3: Receive documents

• After receiving the dossier, the dossier-receiving agency shall pay the requesting establishment the dossier receipt form according to Form No. 01 in Appendix I enclosed with Decree 54/2017/ND-CP.
• The dossier-receiving agency shall issue the Certificate of eligibility for pharmaceutical business within 20 days from the date stated on the dossier receipt form, in case the material, technical and personnel establishments have been inspected and assessed to meet Good Practices in accordance with the scope of business, not having to conduct an actual assessment at the establishment applying for the Certificate of eligibility for pharmaceutical business.
• The dossier-receiving agency shall organize the actual assessment at the establishment applying for the Certificate of eligibility for pharmaceutical business within 20 days from the date stated on the dossier receipt form.
• When there is a request to amend or supplement the dossier in the case specified at Point a, Clause 3 of this Article, within 07 working days from the date stated on the dossier receipt form, the dossier-receiving agency shall send a written request to the requesting establishment, which must specify the documents, contents to be amended and supplemented.

Step 4: Procedures after issuance of the Certificate of eligibility for pharmaceutical business

Within 05 working days from the date of issuance of the Certificate of eligibility for pharmaceutical business, the dossier-receiving agency shall announce and update on the institutional unit’s portal the following information:

• Name and address of the establishment to which the Certificate of eligibility for pharmacy business is granted;
• Full name of the person responsible for pharmacy expertise, number of pharmacy practice certificate;
• Certificate of eligibility for pharmacy business.

If you want to establish a pharmaceutical company, please contact Viet An Law Firm for the fastest support!