Conditions for manufacturers of traditional drugs sold nationwide in Vietnam

Conditions for manufacturers of traditional drugs sold nationwide in Vietnam
Lê Trương Quốc Đạt

What are the regulations on the conditions for manufacturers of traditional drugs sold nationwide in Vietnam? - Hoang My (Tien Giang, Vietnam)

Điều kiện với cơ sở sản xuất thuốc cổ truyền lưu hành toàn quốc

Conditions for manufacturers of traditional drugs sold nationwide in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Conditions for manufacturers of traditional drugs sold nationwide in Vietnam

According to Clause 2, Article 69 of the Law on Pharmacy 2016, the manufacturers of traditional drugs sold nationwide and retailers of traditional drugs in Vietnam must satisfy the following conditions:

- A manufacturer of traditional drugs must have the premises, factory, laboratory, storage of drugs and medicinal ingredients, auxiliary systems, equipment, machinery for manufacture, testing, storage of drugs, quality control system, technical documents and personnel that fulfill Good Manufacturing Practice requirements applied to traditional drugs;

- A retailer of herbal ingredients, herbal drugs, or traditional drugs must comply with regulations on the premises, storage area, storage equipment, technical documents and personnel;

- The chief pharmacist and the person in charge of quality assurance of a manufacturer of traditional drugs must have any of the qualifications specified in Point a or Point c of Clause 1 Article 13 of the Law on Pharmacy 2016 and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point d of Clause 3 of the Law on Pharmacy 2016.

The chief pharmacist of a manufacturer of traditional drugs being sold nationwide may also be in charge of quality assurance therein;

- The chief pharmacist and the person in charge of quality assurance of business household or cooperative manufacturing traditional drugs must have any of the qualifications specified in Point a, c, e, g, i or l of Clause 1 Article 13 of the Law on Pharmacy 2016 and at least 02 years’ apprenticeship at a suitable pharmacy establishment, except for the case in Point c Clause 2 Article 13 of the Law on Pharmacy 2016.

The chief pharmacist of a cooperative or business household manufacturing traditional drugs may also be in charge of quality assurance therein;

- The chief pharmacist of a retailer of traditional drugs shall comply with provisions of Clause 4 Article 18 of the Law on Pharmacy 2016.

2. Regulations on registration, sale, recall of traditional drugs in Vietnam

Regulations on registration, sale, recall of traditional drugs in Vietnam under Article 71 of the Law on Pharmacy 2016 are as follows:

(1) The registration, sale, and recall of traditional drugs being sold on the market shall comply with Chapter V of the Law on Pharmacy 2016, except for cases item (2)

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

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

- 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;

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

- 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 the Law on Pharmacy 2016 are not required to be registered.

The head of the health facility is responsible for recalling drugs that are found unqualified, unsafe, or ineffective.

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