View Measure
| Name | Licensing import of drugs containing active ingredients without the certificate of drug registration of drugs or drugs containing herbal ingredients that are used in Vietnam for the first time |
|---|---|
| Description | The import of such a drug shall only be licensed when the following requirements are satisfied: a) The drug is licensed in one of the following country: manufacturing country, reference country that is a member state of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or Australia; b) The drug is used for treatment for a fatal disease, sexually transmitted disease, or dangerous and new epidemic announced by the Minister of Health; c) There are sufficient clinical data about the safety and efficacy of the drugs in accordance with regulations on drug registration promulgated by the Minister of Health. In case of a vaccine, it is required to submit the result of clinical in Vietnam in accordance with regulations on drug registration promulgated by the Minister of Health. |
| Comments | Application for the import license: in Article 65 Decree 54/2017/NĐ-CP |
| Validity From | 01-07-2017 |
| Validity To | 31-12-9999 |
| Reference | |
| Technical Code | |
| Agency | Ministry of Health |
| Created Date | 2018-01-18 09:47:41 |
| Updated Date | 2018-01-18 09:47:41 |
| Status | Inactive |
| Measure Type | Licensing Requirement |
| Legal/Regulation | Decree 54/2017/ND-CP dated May 08, 2017, guidelines for implementation of the Law on Pharmacy |
| Un Code |
Procedures
| Procedure Name | Description | Category | View Procedure Detail with Relevant Forms |
|---|---|---|---|
| No results found. | |||
This measure applies to commodity/s
| HS Code | Description |
|---|---|
| No results found. | |
Member Area
Search this Site
Contents
|
A Quick Intro |
Search Trade Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feature Information
|
|
|
|
|
|
|
|
|
|
|
.png){kind=small}
Information & Articles
|
|
|
|
|
|
|
|
|
|
|
.png){kind=small}
|
Contact Us! If you cannot find what you require in this website please feel free to contact us. Click here to send us a message >>>
|
Upcoming Events