What documents are required to open a pharmacy in 2024 in Vietnam?

What documents are required to open a pharmacy in 2024 in Vietnam?

Pursuant to Clause 1 Article 28 of the Law on Pharmacy in 2016 stipulating application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business as follows:

Application for issuance, reissuance, adjustment of Certificate of eligibility for pharmacy business

1. An application for the Certificate of eligibility for pharmacy business in the cases mentioned in Point a and Point c Clause 1 Article 36 hereof consists of:

a) An application form for issuance of the Certificate of eligibility for pharmacy business;

b) Corresponding technical documents of the pharmacy business establishment specified in Clause 2 Article 32 hereof;

c) A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;

d) A certified true copy of the pharmacy practice certificate.

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As regulations above, the documents required to open a pharmacy in 2024 in Vietnam is the application for issuance of Certificate of eligibility for pharmacy business, including:

- An application form for issuance of the Certificate of eligibility for pharmacy business;

- Corresponding technical documents of the pharmacy business establishment specified in Clause 2 Article 32 hereof;

- A certified true copy of the certificate of enterprise registration or legal documents proving the existence of the establishment;

- A certified true copy of the pharmacy practice certificate.

What documents are required to open a pharmacy in 2024 in Vietnam? - image from internet

Instructions on Opening a Pharmacy in 2024 in Vietnam

Pursuant to Article 33 of the Decree 54/2017/ND-CP (amended by Clause 12 and 79, Article 5 of the Decree 155/2018/ND-CP) stipulating procedures for issuance of the Certificate of eligibility for pharmacy business as follows:

Procedures for issuance of the Certificate of eligibility for pharmacy business

1. The applicant shall submit an application, directly or by post, to:

a) the Ministry of Health in any of the cases mentioned in Point a, b, c, e, g, h Clause 2 Article 32 of the Law on Pharmacy;

b) the Department of Health of the province where the applicant’s headquarters are located in any of the cases mentioned in Point d and dd Clause 2 Article 32 of the Law on Pharmacy;

2. After receiving the application, the receiving authority shall give the applicant form No. 01 in Appendix I enclosed herewith.

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According to above regulations, the procedures of opening a pharmacy in 2024 is carried out as follows:

Step 1: Submitting the application

The establishment requesting a Certificate of eligibility for pharmacy business submits the application directly or sends it by mail to the Department of Health where the establishment is located.

Step 2: Receiving the application

The Department of Health where the establishment is located receives the application and provides the establishment with a Receipt of Application.

Step 3: Department of Health where the establishment is located shall implement following works:

(1) In case there is a request for amendment or supplementation of the application

When there is a request for amendment or supplementation of the application, within a period of 7 working days from the date indicated on the Receipt of Application, the receiving agency sends a written document to the establishment requesting the specific documents and content to be amended or supplemented.

(2) In case there is no request for amendment or supplementation of the application

- Issuing the Certificate of eligibility for pharmacy business within a period of 20 days from the date indicated on the Receipt of Application for cases where the facilities, technical aspects, and personnel have been inspected and evaluated to meet Good Practice appropriate for the scope of business, without the need for an on-site evaluation at the establishment applying for the Certificate of eligibility for pharmacy business;

- Conducting on-site evaluation at the establishment applying for the Certificate of eligibility for pharmacy business within a period of 20 days from the date indicated on the Receipt of Application.

Step 4: Issuing the Certificate of eligibility for pharmacy business.

What locations are allowed to open dispensaries in Vietnam?

Pursuant to Article 36 of the Decree 54/2017/ND-CP stipulating procedures for issuance of the Certificate of eligibility for pharmacy business as follows:

Locations of retailing dispensaries and drug counters

1. Locations of retailing dispensaries

a) Retailing dispensaries may be opened in communes and small towns;

b) If the ratio of dispensary to 2,000 people in ward that has just been converted from a commune or small town is smaller than 1, new retailing dispensaries may be opened for up to 03 years from the conversion date.

c) A retailing dispensary which is opened in an area other than those mentioned in Clause 1a of this Article and already granted a certificate of eligibility for drug business before the effective date of this Decree may operate until the expiration date of the certificate. If the certificate of eligibility for drug business does not have an expiration date, it may operate for up to 03 more years from the effective date of this Decree.

2. Locations of drug counters:

a) In medical stations of communes;

b) In medical stations of communes in ethnic areas, mountainous areas, islands, extremely disadvantaged areas.

As regulations above, locations allowed to open dispensaries in Vietnam are as follows:

- Retailing dispensaries may be opened in communes and small towns;

- If the ratio of dispensary to 2,000 people in ward that has just been converted from a commune or small town is smaller than 1, new retailing dispensaries may be opened for up to 03 years from the conversion date.

- A retailing dispensary which is opened in an area and already granted a certificate of eligibility for drug business before 01/7/2017 may operate until the expiration date of the certificate. If the certificate of eligibility for drug business does not have an expiration date, it may operate for up to 03 more years from the effective date of this Decree.

Best regards!