Registration of additional pharmaceutical packaging specifications

During the process of circulating drugs in the Vietnamese market, manufacturers want to produce products in many different forms such as spray or roll-on to meet many different consumer purposes. Adding a new packaging specification for pharmaceutical products will require additional registration procedures for the Drug Circulation License. 

I. Packaging 

A typical pharmaceutical product will be packaged in many different dosage forms such as tablets, liquids, injectable powders, powder, cream, patch, spray or aerosol, combination kit, or decoction.⁸ The above mentioned dosage forms are called a packaging unit. Each packaging unit is considered a packaging specification. In which, the packaging specification is expressed in the natural count of the quantity, weight, and volume of the drug contained in the commercial packaging.⁹ For example, Panadol tablets are packaged in blister packs of 12 tablets per blister. 

Packaging specifications are one of the important and mandatory contents that must be shown on the outer packaging label of the drug according to the provisions of Article 7 of Circular 01/2018/TT-BYT. This information helps consumers know the quantity of drugs contained in a commercial packaging. 

II. Adding a new form of packaging is considered additional packaging. 

Before determining the procedures and components of the dossier to be performed, the manufacturer or drug registration unit needs to determine whether the addition of a new bottle packaging form is a case of adding primary or secondary packaging, specifically:¹⁰ 

1. Primary packaging is understood as packaging that is in direct contact with drugs (also known as primary packaging or level 1 packaging) is packaging used to contain, have direct contact with drugs, create shapes, blocks or tightly wrap drugs according to shapes, blocks, such as aluminum film, PVC film, drug tubes… 
2. Secondary packaging, outer packaging (also known as secondary packaging or secondary packaging) is packaging used to package one or several units of medicine that are contained in direct packaging, not in direct contact with the medicine, such as paper boxes, outer aluminum lids, etc. 

Based on the above provisions, a newly applied form of packaging is considered as supplementing a primary packaging because the bottles and jars are in direct contact with the drug. 

III. Additional packaging procedures 

III.1. Profile components 

The procedure for additional registration of primary packaging is one of the minor changes specified in Appendix I of Circular 12/2025/TT-BYT and must be approved before implementation and must be registered with the Department of Drug Administration.¹¹  

The necessary conditions and dossier components for the registration procedure for additional primary packaging specifications include:¹² 

III.2. Carry out procedures to supplement the Drug Circulation Registration Certificate at the Department of Drug Administration 

The content of supplementing the primary packaging specifications is one of the supplementary contents of the Drug Circulation Registration Certificate. Specifically, the product label is the essential content of the administrative records in the drug registration dossier. When there is a change or supplement to the product label, Borden must register the change or supplement to the Drug Circulation Registration Certificate. 

In this case, the dossier to supplement the GMO product packaging specifications must be approved by the Drug Administration of Vietnam to supplement the Drug Circulation Registration Certificate based on dossier appraisal without requiring dossier appraisal and consultation from the Council according to Point b, Clause 2, Article 43 of Circular 12/2025/TT-BYT. 

III.3. Fees for additional procedures for drug circulation registration at the Department of Drug Administration: 

The fee for 01 set of documents is 1,500,000 VND.¹³ 

III.4. Time to process the application 

The time to process additional application for Drug Circulation Registration Certificate is no more than 03 months from the date of receipt.¹⁴ 

^{(8) Clause 2, Article 28, Circular 01/2018/TT-BYT.}

^{(9) Point a, Clause 2, Article 28, Circular 01/2018/TT-BYT.}

^{(10) Article 1.2 Appendix 1 Circular 14/2012/TT-BYT.}

^{(11) Clause 3 and Clause 2, Article 1, Section A, Appendix I, Circular 12/2025/TT-BYT.} 

^{(12) Appendix II Circular 12/2025/TT-BYT}

^{(13) No. 5, Fee Schedule in the Pharmaceutical and Cosmetic Field, Circular No. 41/2023/TT-BTC} 

^{(14) Point b, Clause 2, Article 47, Circular 12/2025/TT-BYT.}

Date Written: 20/08/2025

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