Establish foreign-owned export-import pharmaceutical products company

Demand on pharmaceutical products is always high, not only from hospitals or medical stations but also from the citizens themselves. Foreign pharmaceutical products are more expensive but are trusted as high quality and their modern manufacturing process. Foreign investors can establish foreign-own company to export and import pharmaceutical products to Vietnam. In order to give you Clients a hand, Viet An Law Firm collects and provides some regulations and related procedures as follows:

Step 1: Apply for Investment Registration Certificate (for foreign investors):

An application for the Investment Registration Certificate includes:

• A written request for permission for project execution;
• Individual investors: copies of ID or passport of each individual;
• Organization investors: copies of Establishment Certificate or equivalent paper confirming the legal status;
• Project proposal specifying: the investors, project’s objectives and scale; capital and capital rising method; location, duration and schedule of the project; labor demand;
• Copies of financial statements in the current 02 years or financial support commitment of the parent company or financial institutions; guarantee for investors’ financial capacity, description of investors’ financial capacity; request for investment incentives; assessment of socio-economic effects of the project;
• Land use demand. If the project does not use land allocated or leased by the State or does not require the State to change land use purpose, the copies of the lease agreement or equivalent papers proving that investors have rights to use the location shall be submitted;
• If the project use any technology in the List of technologies restricted from transfer, investors have to submit the explanation on technology transfer.

Submit the application at: The Department of Planning and Investment.

The process: Within 15 days from the receipt date of the valid application, the Department of Planning and Investment will grant the Investment Registration Certificate to foreign investors. If the Department of Planning and Investment refuse to grant, they will respond in notices and explain the reasons.

Step 2: Apply for Business Registration Certificate:

An application for the Business Registration Certificate includes:

• A written request for business registration;
• The Articles of Associates;
• The list of members of the multi-member limited liability company or the list of partners of partnership;
• Notarized copies of ID or valid passport of each individual member; notarized copies of the Business Registration Certificate/Establishment Certificate of each organization member; notarized copies of ID or valid passport of each legal representative of each organization;
• Power of attorney (Clients grant to Viet An);
• Certificate of Investment Registration of foreign investors.

Submission place: The Department of Planning and Investment.

Duration: 03 – 06 working days.

Announce the business registration contents:

• Business registration information must be announced publicly on the National Portal of Business Registration within 30 days from the date of issuance of the Business Registration Certificate. The contents of the announcement are all the information stated in the Business Registration Certificate.
• Notice: In accordance with Clause 1 Article 26 of the Decree 50/2016/NĐ-CP, if the company does not announce or lately announce the business registration information on National Portal of Business Registration, they are fined an amount of money from 1.000.000 VND to 2.000.000 VND.

Engrave the seal and publish the seal sample:

• The company can authorized Viet An Law Firm or can engrave the seal by itself then announce the seal sample to the Department of Planning and Investment. The company is allowed to decide about the appearance, quantity and the contents of the deal but it must contain the name and the code of the company;
• After receiving the announcement on the seal sample, the Business Registry Office shall grant the receipt to the company, post the announcement on the National Portal of Business Registration and issue the Announcement on Publication of the seal sample to the company.

Step 3: Apply for Eligibility for pharmacy business Certificate:

An application for Eligibility for pharmacy business Certificate includes:

• A written request for issuance of Eligibility for pharmacy business Certificate (Form 19 – Annex I Decree No. 54/2017/NĐ-CP);
• Technical documents of the pharmacy business: locations, storages, materials, storage facilities, transportation, quality management system, professional documents and labor documents;
• Notarized copy of the Business Registration Certificate;
• Notarized copy of pharmacy practice.

Place of submission: the Ministry of Health

Duration:

If the application is full and valid:

If facilities and labor have been testified, evaluated fitting the business scope, no actual assessment is required, the Ministry of Health shall issue the Eligibility for pharmacy business Certificate within 30 days from the date on the receipt note.

In case the assessment is required, it must be conducted within 20 days from the date on the receipt note. If there is no requirement on changes, the Ministry of Health shall issue the Eligibility for pharmacy business Certificate within 10 working days from the date of assessment completion. If there is any requirement on changes, the Ministry of Health shall issue announcement within 05 working days from the assessment completion. Within 20 days from the date of announcement issuance and documents proving completion of changes, the Ministry of Health shall issue the Eligibility for pharmacy business Certificate or provide explanation if refuse to issue one.

If the application has to be adjusted and supplemented:

Within 10 working days from the date on the receipt note, the Ministry of Health shall send a suggestion specifying contents, documents need to be adjusted or supplemented. If the adjusted and supplemented application does not meet the requirement, the Ministry of Health shall issue an announcement.

Notice: Within 06 months from the date of announcement of the Ministry of Health, the applicant shall submit the new application as required. After the above time, if the applicant does not submit the new application or after 12 months from the first application, the supplemented application does not meet the requirements, the submitted application shall become invalid.

Foreign investment consulting services at Viet An Law Firm:

• Consult about foreign investment regulations and procedures in Vietnam;
• Consult about regulations and application for Investment Registration Certificate, Business Registration Certificate, sublicenses…;
• Consult about conditional business sectors and detailed conditions for each sectors applied to foreign investors;
• Consult about capital contribution, shares purchase, capital contribution purchase which is a simpler investment method, save time and money;
• Consult about after-establishing legal issues: contracts, labor, practices, tax, commercial franchise, social insurance…

If you are looking for advice about regulations and procedures related to foreign investment in Vietnam, please feel free to contact Viet An Law Firm for more information!