Types of registration of drugs and medicinal ingredients in Vietnam

Types of registration of drugs and medicinal ingredients in Vietnam (Internet image)

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

1. Drugs and medicinal ingredients to be registered in Vietnam

According to Article 54 of the Law on Pharmacy 2016, the drugs and medicinal ingredients to be registered are as follows:

- Drugs must be registered before free sale in Vietnam, except for:

+ Drugs prepared by prescription at drugstores as specified in Point b Clause 1 Article 47; drugs manufactured or prepared at health facilities as specified in Article 85 hereof;

+ Imported drugs specified in Clause 2 Article 60 of the Law on Pharmacy 2016;

+ Traditional drugs specified in Clause 1 and Clause 2 Article 70 of the Law on Pharmacy 2016.

- Medicinal ingredients must be registered before free sale in Vietnam, except for:

+ Medicinal ingredients that are active ingredients for drug manufacture according to applications for drug registration that are granted certificates of free sale in Vietnam;

+ Imported medicinal ingredients specified in Clause 3 Article 60 of the Law on Pharmacy 2016.

- The following entities may register drugs/medicinal ingredients:

+ Any establishment manufacturing, wholesaling, exporting, importing drugs/medicinal ingredients in Vietnam;

+ Any foreign establishment trading in drugs/medicinal ingredients and having a representative office in Vietnam.

- A drug or medicinal ingredient shall be granted the certificate of free sale in Vietnam when the following requirements are satisfied:

+ Safety and efficacy requirements are satisfied;

+ It is manufactured by a manufacturer that satisfies the conditions specified in the Law on Pharmacy 2016.

+ It is manufactured according to manufacture procedures and satisfy quality standards prescribed in Article 102 and Article 103 of the Law on Pharmacy 2016.

- When registering an imported drug or medicinal ingredient for free sale in Vietnam, its foreign manufacturer must assess the fulfillment of GMP requirements using any of the following methods:

+ Assessing documents about manufacturing conditions;

+ Mutual recognition of inspection results given by pharmacy authorities regarding the fulfillment of GMP requirements;

+ Inspection at the manufacturing facility.

2. Types of registration of drugs and medicinal ingredients in Vietnam

Types of registration of drugs and medicinal ingredients in Vietnam according to Article 55 of the Law on Pharmacy 2016 are as follows:

- A drug or medicinal ingredient shall be registered by either:

+ Issuance of a certificate of free sale;

+ Renewal of a certificate of free sale;

+ Adjustment of a certificate of free sale.

- A certificate of free sale shall be issued in the following cases:

+ The drug or medicinal ingredient has not been issued with any certificate of free sale in Vietnam;

+ The drug already has a certificate of free sale but there are changes to its active ingredients, herbal ingredients or concentrations thereof, dosage form, administration route, manufacturer (except for secondary packaging facility, releasing facility, or releasing location);

+ The medicinal ingredient already has a certificate of free sale but there are changes to its manufacturer (except for secondary packaging facility, releasing facility, or releasing location).

- A certificate of free sale issued in Vietnam may be adjusted before its expiry, except for the cases in Point b and Point c Clause 2 of this Article.

- A certificate of free sale shall be renewed when it expires, including drugs/medicinal ingredients whose administrative documents are changed on the renewal date.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE