Conditions for opening a private pharmacy in Vietnam in 2020

1. Conditions for opening a private pharmacy in Vietnam

According to the provisions at Point d, Clause 1, Article 33 of the Pharmacy Law 2016, a private pharmacy in Vietnam must meet the following requirements regarding physical and technical facilities: having a location, storage area, storage equipment, technical documentation, and personnel that comply with Good Pharmacy Practice (GPP) for retail establishments.

Also, according to the provisions in Clause 1, Article 18 and Clause 2, Article 33 of the Pharmacy Law 2016, the person responsible for the pharmacy's professional activities must have one of the following professional qualifications:

- Bachelor's degree in pharmacy (hereinafter referred to as Pharmacist degree);- College diploma in pharmacy;- Intermediate diploma in pharmacy.

Furthermore, the person responsible for professional activities in pharmacy must have 18 months of professional practice at an appropriate pharmacy facility.

Latest procedures for opening a private pharmacy in Vietnam in 2020 (Illustrative image)

2. The pharmacy must be registered as a household business in Vietnam

To be granted a Certificate of eligibility for pharmacy business, the pharmacy business must first be issued a business registration certificate by a competent state agency in accordance with the Enterprise Law 2014 and related legislative documents in Vietnam.

For individuals wishing to open a private pharmacy on their own, the most suitable business model is to register as an individual household business in accordance with Decree 78/2015/ND-CP on enterprise registration and Circular 20/2015/TT-BKHDT guiding enterprise registration.

According to Clause 1, Article 71 of Decree 78/2015/ND-CP, the dossier for household business registration in Vietnam includes:

- Application for household business registration;

- A valid copy of the citizen identification card or identity card or valid passport of individuals participating in the household business or the representative of the household;

- A valid copy of the meeting minutes of the individual group on the establishment of a household business in the case of a household business founded by a group of individuals.

Procedures for household business registration are as follows:

- The household business submits one dossier to the district-level business registration office where the business is located or sends it by post.

- The business registration office receives the dossier. Upon receiving the dossier, the district-level business registration office issues a receipt and grants a household business registration certificate within 03 working days from the date of receiving the dossier, if the following conditions are met:

- The business lines are not prohibited from doing business;- The proposed household business name complies with the provisions in Article 73 of Decree 78/2015/ND-CP;- Full payment of the registration fee as prescribed.

3. Applying for a Certificate of eligibility for pharmacy business in Vietnam

Dossier for Applying for the Certificate of Eligibility:

After obtaining the Business Registration Certificate, the pharmacy owner proceeds with the procedures to issue the Certificate of eligibility for pharmacy business to be legally qualified for retailing drugs under current law.

According to Clause 1, Article 38 of the Pharmacy Law 2016 and Article 32 of Decree 54/2017/ND-CP, the dossier for the Certificate of eligibility for pharmacy business includes:

- Application for the Certificate of eligibility for pharmacy business as per Form 19 Appendix I of Decree 54/2017/ND-CP;- Documents on location, storage area, storage equipment, technical documentation, and personnel in compliance with Good Pharmacy Practice (GPP) principles for retail establishments;- Certified copy of the Business Registration Certificate or legislative documents proving the establishment of the pharmacy;- Certified copy of the Pharmacy Practice Certificate.

Procedures for Issuing the Certificate of eligibility for pharmacy business:

According to Clause 2, Article 37 of the Pharmacy Law 2016, the Director of the Department of Health where the pharmacy is located has the authority to issue Certificates of Eligibility for Pharmaceutical Business for retail establishments.

The process for issuing the Certificate of eligibility for pharmacy business follows these steps:

Step 1: Submit the dossier

Submit directly or send by post to the Department of Health where the pharmacy's business is located, as stipulated in Clause 1, Article 39 of the Pharmacy Law 2016 and Clause 1, Article 33 of Decree 54/2017/ND-CP.

Step 2: Receive the dossier

After receiving the dossier, the receiving agency issues a Receipt of Dossier as per Form 01 in Appendix I attached to Decree 54/2017/ND-CP.

Step 3: Dossier appraisal

If there are no requirements for modification or supplementation, the agency issuing the Certificate of eligibility for pharmacy business will:

- Issue the Certificate of eligibility for pharmacy business within 30 days from the date stated on the Receipt of Dossier if the physical, technical, and personnel conditions have been inspected and assessed to meet the appropriate Good Pharmacy Practice standards, without requiring an actual assessment at the requesting pharmacy establishment.

- Conduct an actual assessment at the requesting pharmacy within 20 days from the date stated on the Receipt of Dossier.

In case of a request for modification or supplementation, within 10 working days from the date stated on the Receipt of Dossier, the dossier receiving agency sends a written notice to the requesting pharmacy, clearly stating the documents and contents that need to be modified or supplemented.

After receiving the modified and supplemented dossier, the dossier receiving agency issues a Receipt of Modified and Supplemented Dossier as per Form 01 in Appendix I attached to Article 33 of Decree 54/2017/ND-CP:

- If the modified and supplemented dossier does not meet the requirements, the dossier receiving agency shall issue a written notice to the pharmacy as per Clause 4, Article 33 of Decree 54/2017/ND-CP.

- If there are no requests for modification or supplementation of the modified and supplemented dossier, the dossier receiving agency proceeds according to Clause 3, Article 33 of Decree 54/2017/ND-CP.

Step 4: Actual assessment and issuance of the Certificate of eligibility for pharmacy business

According to Clause 6, Article 33 of Decree 54/2017/ND-CP, after conducting an actual assessment, the agency issuing the Certificate of eligibility for pharmacy business is responsible for:

- Issuing the Certificate of eligibility for pharmacy business within 10 working days from the completion of the actual assessment if there are no requirements for rectification and correction;

- Issuing a written notice on the contents that need to be rectified and corrected within 05 working days from the completion of the actual assessment if there are requirements for rectification and correction.

According to Clause 7, Article 33 of Decree 54/2017/ND-CP, within 20 days from the receipt of the written notice and proof of completion of rectification and correction from the requesting pharmacy, the agency issuing the Certificate of eligibility for pharmacy business shall issue the Certificate or provide a written explanation for not issuing the Certificate.

According to Clause 9, Article 33 of Decree 54/2017/ND-CP, within 05 working days from the issuance of the Certificate of eligibility for pharmacy business, the dossier receiving agency shall announce and update the following information on the unit's electronic portal:

- Name and address of the pharmacy granted the Certificate of eligibility for pharmacy business;- Full name of the person responsible for pharmacy professional activities, and the number of the Pharmacy Practice Certificate;- Number of the Certificate of eligibility for pharmacy business.

According to Clause 11, Article 33 of Decree 54/2017/ND-CP, the Certificate of eligibility for pharmacy business shall be prepared in 02 copies as per Form 22 in Appendix I attached to Decree 54/2017/ND-CP: 01 copy for the requesting pharmacy; 01 copy retained by the issuing agency.

Additionally, in cases where the pharmacy has been assessed as meeting Good Pharmacy Practice standards, the issuing agency shall issue a Good Pharmacy Practice Certificate if the pharmacy requests one.

Duc Thao

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