Conditions for establishing a pharmaceutical company

Create at: 31/05/2022 16:26

1. What is a pharmaceutical company?

✨ A pharmaceutical or drug trading company is a type of company dealing in all kinds of compounds, which are synthesized from different ingredients and have been verified for their quality origin.

✨ The pharmaceutical business is a conditional field and is strictly managed by the Ministry of Health. Business products are intended for human consumption or for animals or plants. To treat pathology, physiology, or to contribute to the diagnosis of disease.

✨Pharmaceutical business forms:

✔ Manufacture of medicines.

✔ Producing traditional medicine.

✔ Producing chemicals for testing,

✔ Selling medicine

✔ Selling traditional medicine.

✔ Sell testing chemicals.

2. Conditions for establishing a pharmaceutical trading company:

2.1. Owner conditions:

🔰 According to the provisions of Article 17 of the Enterprise Law 2020, organizations and individuals may establish and manage enterprises, except for a number of cases as follows:

➥ State agencies and units of the people's armed forces use state assets to establish profit-making enterprises for their own agencies or units;

➥ Cadres, civil servants according to the provisions of the Law on Cadres and Civil servants and the Law on Officials;

➥ Officers, non-commissioned officers, professional soldiers, defense workers, and officers in agencies and units of the Vietnam People's Army; officers, professional non-commissioned officers, and police in agencies and units of the Vietnam People's Public Security, except those who are appointed as representative to manage the State's capital contribution in enterprises or management at a state-owned enterprise;

➥ Professional leaders and managers in state-owned enterprises as prescribed at Point a, Clause 1, Article 88 of this Law, except those who are appointed as representatives to manage the State's capital contribution in enterprises in other enterprises;

➥ Minors; people with limited civil act capacity; persons who have lost their civil act capacity; people with difficulties in cognition and behavior control; organizations without legal status;

➥ Persons who are being examined for penal liability, detained, are serving prison sentences, are serving administrative handling measures at compulsory detoxification establishments, a compulsory educational institution, or being banned by a court from holding certain posts, practicing certain professions, or doing certain jobs; other cases as prescribed by the Law on Bankruptcy and the Law on Anti-corruption.

2.2. Facilities conditions:

🔗 Must have a means of transporting drugs;

🔗 Must have ancillary systems, quality management systems, and technical documentation;

🔗 There must be a place, place of production, testing, and storage of drugs and medicinal ingredients;

🔗 Must have equipment and machinery in service of drug production, testing, testing, preservation...

2.3. Personnel conditions:

🔗 Must have personnel who meet Good Manufacturing Practices for each form of the drug business, for example, for drug manufacturing, personnel must meet Good Manufacturing Practices, for drug retail, personnel must meet the Good Practice of drug retail establishments…;

🔗 A pharmacy practice certificate is required for personnel holding the following positions:

➥ Personnel responsible for pharmacy expertise for pharmaceutical business establishments;

➥ Personnel in charge of quality assurance at establishments manufacturing drugs and medicinal ingredients;

➥ Personnel in charge of clinical pharmacy at medical examination and treatment facilities.

3. Procedures for setting up a pharmaceutical company:

3.1. Place of business license:

🔗 Where to receive business establishment documents: at the Department of Planning and Investment,

🔗 The place to receive the application for a license for pharmaceutical production and business activities: the Ministry of Health

3.2. Procedures for setting up a pharmaceutical company:

👉 Step 1: Advise business people on the regulations on setting up a company

👉 Step 2: Prepare documents and give them to business people to sign.

👉 Step 3: TASCO will submit the application on your behalf and receive the results.

👉 Step 4: Hand over the registration certificate to entrepreneurs.

👉 Step 5: Post-establishment consultation.

3.3. Performance records include:

⏩ For the application for a license to establish a pharmaceutical company:

● Notice of request for enterprise registration according to the form prescribed by the Ministry of Planning and Investment

● A copy of the draft charter of the enterprise

● List of members and shareholders (For companies with 2 or more founding members)

● Copy of ID card, citizen identification, Passport, or other personal identification (For individual members)

● A copy of the establishment decision, business registration certificate, or another equivalent document of the organization; written authorization, ID card, passport, or other lawful personal identification of the authorized representative (For members being organizations)

● Authorization letter to submit documents and receive results (in case the trader is not the representative).

⏩ For the application for a GPP permit for the retail sale of pharmaceuticals and drugs:

●Copy of business registration license

● Copy of Pharmacy Practice Certificate (University level)

● ID card or citizen identity card of the pharmacist

● Organization chart and list of pharmacists

● Drawings, and floor plans of pharmaceutical warehouses

● List of equipment and tools of the establishment

⏩ For the application for a GPP permit for the case of wholesale pharmaceuticals, drugs

●Copy of business registration license

● Copy of Pharmacy Practice Certificate (University level)

● ID card or citizen identity card of the pharmacist