HOW TO START A PHARMACEUTICAL COMPANY OWNED BY A FOREIGNER IN VIETNAM?

Starting a pharmaceutical company in Vietnam as a foreigner can be challenging, but it offers great opportunities in the growing healthcare market. Vietnam’s pharmaceutical industry is expanding due to increasing healthcare needs and supportive government policies. However, foreign investors must follow strict laws and procedures to set up their businesses. This article simplifies the steps and legal requirements for starting a company in the pharmaceutical sector in Vietnam, from understanding your rights to preparing the necessary documents.

How can I start a pharmaceutical company in Vietnam?

Foreign investors entering the pharmaceutical market in Vietnam must understand the legal rights granted to them and identify sectors in which they can participate. Below are the key considerations for navigating the industry.

FIEs’ rights in the pharmaceutical sector

Foreign-invested enterprises (FIEs) in Vietnam’s pharmaceutical sector are granted specific rights and responsibilities under Vietnamese law. According to Article 2 of Circular 34/2013/TT-BCT:

FIEs can export goods not listed in Appendix 01 of the Circular.
FIEs can import goods not listed in Appendix 02.
FIEs can distribute goods not listed in Appendix 03.
All activities must comply with the Circular and related legal documents.

FIEs in Vietnam cannot distribute pharmaceuticals unless they are locally manufactured

In addition, Clause 10, Article 91 of Decree 54/2017/ND-CP of the Law on Pharmacy 2016 states: “Foreign-invested enterprises have the right to import medicines and raw materials for medicine production but cannot distribute these products, except for those they manufacture within Vietnam.” Therefore, FIEs may import pharmaceuticals but are restricted from distributing them unless the goods are produced locally. Imported medicines are generally intended for research or production rather than direct sale. Vietnam’s regulations distinguish between imported medicines with registration certificates and those requiring special permits:

Medicines with a valid circulation registration certificate can be imported without additional licensing.
Medicines under special control or without a registration certificate require an import license.

Other sectors FIEs can participate in

Apart from pharmaceuticals, foreign investors can consider alternative sectors like cosmetics and dietary supplements. These sectors often involve less stringent restrictions and offer lucrative market opportunities. For example, cosmetics fall under consumer goods and dietary supplements under functional foods, which have a more streamlined regulatory framework. Establishing a cosmetic company or supplement business involves fewer restrictions on import and distribution rights, making it an attractive choice for foreign investors looking to diversify their investments in Vietnam. Investors should assess market demand, regulations, and the competitive landscape before deciding on the sector to enter.

Foreign investors can also explore opportunities in sectors like cosmetics and dietary supplements

Guide for FIEs to set up a company to import medicines

To establish a pharmaceutical company in Vietnam focused on importing medicines, foreign investors must carefully prepare and comply with legal and financial requirements. The following subsections explore costs and qualifications.

How much does it cost to start a pharmaceutical company to import medicine in Vietnam?

Starting a pharmaceutical company involves various costs depending on factors like company size, operational scope, and specific business needs. Key expenses include legal and registration fees, facility setup for compliance, and working capital for operational activities. These costs can vary significantly based on the business plan and market conditions. Proper financial planning and understanding regulatory requirements are crucial to successfully managing these costs. Investors should also consider recurring costs like employee salaries, utility bills, and renewing licenses annually.

With G2B, you can streamline your setup process and focus on your core business activities. Our dedicated team is here to help you with all your needs. G2B services provide assistance in setting up a business in Vietnam, offering professional and reliable support, guiding businesses through proper company establishment and annual compliance, opening local bank accounts, ensuring smooth operations, and minimizing legal risks from the outset.

Which degree is required to open a pharmaceutical company?

To start a pharmaceutical company in Vietnam, foreign investors need to fulfil several legal and regulatory requirements. The application for the Investment Registration Certificate requires a written request for project execution, including detailed documentation about the investors, project objectives, capital, and schedule. Additionally, individual investors must provide copies of identification (ID or passport), while organizational investors must submit copies of their Establishment Certificate or equivalent legal status documentation.

Moreover, the application for the Business Registration Certificate requires additional documentation, such as the Articles of Association, the list of members or partners, and notarized copies of ID or passports for each legal representative. It is important to note that the Eligibility for Pharmacy Business Certificate also requires specific documentation, including a request for issuance, technical documents about the business operation, and verification of the qualifications of the business’s key personnel. Notarized copies of the Business Registration Certificate and the pharmacy practice certificate are necessary as well.

The application process involves detailed documentation including personal identification and qualification certificates

Starting a pharmaceutical company in Vietnam as a foreign investor requires careful consideration of the legal framework and market conditions. Foreign investors must ensure compliance with Vietnamese laws regarding importation, distribution, and manufacturing in the pharmaceutical sector. With G2B, you're not just choosing a consultancy to help set up a business in Vietnam, you are choosing a partner who will stand by your side throughout your entrepreneurial journey. Contact G2B today to learn more about how to incorporate in Vietnam in the pharmaceutical sector!