What are eligibility requirements for traditional drug retailing in Vietnam?

What are eligibility requirements for traditional drug retailing in Vietnam?

Pursuant to Clause 5, Article 31 of the Decree 54/2017/NĐ-CP stipulating eligibility requirements for traditional drug retailing in Vietnam as follows:

a) The chief pharmacist of the retailer of herbal ingredients, herbal drugs or traditional drugs shall satisfy the requirements in Clause 4 Article 18 of the Law on Pharmacy;

b) The retailer has an isolated and fixed store which is firmly built; the store area is suitable for its scope of business, located in a high, dry, airy and safe area, at an adequate distance from sources of pollution and ensures fire safety;

c) The storage area and equipment satisfy the storage requirements written on the labels.

Herbal drugs and traditional drugs must be isolated from herbal ingredients and tradition ingredients.

Toxic herbal ingredients (if any) shall be displayed and stored in a separate area. Otherwise, it must be separated from other herbal ingredients and labeled "dược liệu độc” (“toxic ingredients”) to avoid confusion.

Prescription herbal drugs and traditional drugs (if any) shall be displayed and stored in a separate area. Otherwise, it must be separated from OTC drugs and labeled "thuốc kê đơn” (“prescription drug”) to avoid confusion.

The retailer of the herbal drugs, traditional drugs or herbal ingredients shall have suitable storage areas;

d) Instruments and packages in physical contact with herbal drugs, herbal ingredients or traditional drugs must not affect their quality;

dd) Information about purchases, sales and origins of drugs must be properly recorded;

e) The person who retails herbal ingredients, herbal drugs or traditional drugs (the shopkeeper) shall have one of the documents specified in Points a, c, e, g, i or l Clause 1 Article 13 of the Law on Pharmacy.

Regarding toxic herbal ingredients and prescription herbal drugs, the shopkeeper, who directly sells and counsel buyers, must be a pharmacist;

g) Other goods (if any) must be displayed and stored in a separate area and must not affect the herbal ingredients, herbal drugs or traditional drugs.

To be eligible for traditional drug retailing in Vietnam, you shall satisfy requirements on the chief pharmacist, location, instruments, packages, etc.

In which cases shall a traditional drug be exempt from clinical trial in Vietnam?

Pursuant to Article 72 of the Law on Pharmacy in 2016 stipulating clinical trial of traditional drugs before registration in Vietnam as follows:

1. Traditional drugs might or might not be exempt from clinical trials.

2. A traditional drug is exempt from clinical trial if:

a) It is recognized by the Ministry of Health;

b) It is granted a certificate of free sale before the effective date of this Law, unless the Advisory Council demands a clinical trial.

3. The Minister of Health shall provide for the criteria for partial exemption of clinical trial in Vietnam.

Therefore, if a traditional drug is recognized by the Ministry of Health and granted a certificate of free sale, it can be exempt from clinical trial.

What are regulations on registration, sale, recall of traditional drugs in Vietnam?

Pursuant to Article 71 of the Law on Pharmacy in 2016 stipulating registration, sale, recall of traditional drugs in Vietnam as follows:

1. The registration, sale, and recall of traditional drugs being sold on the market shall comply with Chapter V of this Law, except for Clause 2 of this Article.

2. Time limit for issuing, renewing, adjusting a certificate of free sale of a traditional drug:

a) 06 months from the receipt of the satisfactory application for issuance of a certificate of free sale of a traditional drug;

b) 12 months from the receipt of the satisfactory application for issuance of a certificate of free sale or a traditional drug that require clinical trial;

c) 01 month from the receipt of the satisfactory application for renewal or adjustment of a certificate of free sale of a traditional drug;

d) Where an application for issuance, renewal, or adjustment of a certificate of free sale of a traditional drug is rejected, or any of the conditions for it is not satisfied, a written explanation must be provided.

3. Traditional drugs prepared and prescribed within a health facility specified in Clause 1 and Clause 2 Article 70 of this Law are not required to be registered. The head of the health facility is responsible for recalling drugs that are found unqualified, unsafe, or ineffective.

Above are regulations on registration, sale, recall of traditional drugs in Vietnam.

Best regards!