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The pharmaceutical market of Vietnam is experiencing rapid growth due to increasing demand for healthcare services and a growing middle class. In 2024, the projected revenue in Vietnam’s Pharmaceuticals market is estimated to reach USD 2,401.00 million, as the largest segment is the prescript Oncology drugs. In 2023 were brought forth amendments to the existing regulations governing the labeling of pharmaceutical products.

 

 

 

Regulatory Background

 

On November 30, 2023, Vietnam’s Ministry of Health (MoH) issued Circular 23/2023/TT-BYT (hereinafter referred to as ‘the new Circular’). The new Circular brings forth amendments to the existing regulations governing the labeling of pharmaceutical products, providing updates to the provisions established by the previous Circular.

 

The new Circular effective from January 15, 2024, allows drugs or materials made or imported before January 1, 2025, to use existing labels and inserts until the batch expires. Ongoing applications can follow old regulations unless the registrant chooses to adopt the new rules. However, all drugs introduced in Vietnam must fully comply with the new labeling and insert requirements by January 1, 2025.

 

 

 

Track & Trace Requirements

 

The serialization is mandatory, following the GS1 standards. The scope covers the segment of prescription drugs.

 

UDI Code Structure

 

Pharmaceutical Identifier Encryption

• GTIN – GS1 AI (01)

 

Production Identifier Encryption

• Batch number – GS1 AI (10)
• Date of manufacture – GS1 AI (11)
• Expiration date – GS1 AI (17)
• Serial number – GS1 AI (21)

 

Notes: Application identifiers (AI) are specified in TCVN 6754.  

 

 

NDC label code

 

NDC is a 10-digit identifier consisting of two segments: the FDA Assigned Label Code and the Manufacturer-Assigned Product/Package Code.

 

 

 

Strategy for pharmaceutical industry development

 

Setting targets for the development of the domestic pharmaceutical industry for the next decade, the production capacity of Vietnam is expected to meet 80 percent of the domestic demand and its product value will account for 70 percent of the pharmaceutical market’s value.

 

As a part of the strategy, the Vietnam Reporting System is listed as main point, as the plan targeted to ensure the monitoring of all drugs available on the market regarding their effects and safety as specified by the Ministry of Health. Regarding the digital transformation in the pharmaceutical sector, all information and data on drugs licensed for circulation that remain valid in Vietnam will be digitalized and updated onto the Pharmaceutical Industry Data Bank.

 

 

 

If you need more information regarding track and trace regulatory compliance in Indonesia, schedule a free consultation with our expert >> communication@softgroup.eu

 

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Sources:

https://www.statista.com/outlook/hmo/pharmaceuticals/vietnam