Pharmaceutical and functional food packaging: compliant design
The pharmaceutical industry allows no room for design errors; a missing warning line can lead to a recall of the entire batch.
Pharmaceutical and functional food packaging is the most legally constrained packaging group in Vietnam. This group includes blister packs, HDPE bottles, PET bottles, and powder sachets. All must contain sufficient label information, child-resistant mechanisms, seals as tamper-evident indicators, and traceability codes. Compliance with OTC drug manufacturers, dietary supplement companies, and health protection foods requires properly regulated packaging that can be printed immediately.
- OTC medications in tablet and syrup form.
- supplement in HDPE bottles
- health food in tablet and powder form
- Items sold through pharmacies can be sold in blister packs.
- labels missing mandatory warning lines
- products that mimic prescription drugs
- change claims without approval
No industry has as high a cost of errors as pharmaceuticals and functional foods. A missing warning line can be enough for the regulatory authority to mandate a recall of the entire batch. A field with incorrect font size, or a blister missing a batch number, can also be penalized similarly. Therefore, those working in this packaging sector should start with legal constraints first, then discuss aesthetics.
What is pharmaceutical and functional food packaging
This is a packaging group serving two closely related legal areas but differing in the approval process. Over-the-counter (OTC) drugs are regulated by the Drug Administration; drug labels must comply with Circular 01/2018/TT-BYT, amended by Circular 23/2023/TT-BYT. Functional foods, including dietary supplements and health protection foods, are subject to Decree 15/2018/NĐ-CP. Among them, health protection foods must be registered for announcement, while dietary supplements can be self-declared more quickly.
The most common structures by product type:
- OTC tablets: aluminum blister packs and PVC (AL/PVC) with 10 tablets per pack, packaged in boxes containing 3 to 10 packs along with an instruction leaflet.
- High-capacity desiccant: aluminum strip and aluminum (AL/AL) completely sealed, preventing moisture ingress.
- Vitamin OTC and dietary supplements in tablet form: HDPE plastic bottles containing 30 to 100 tablets, child-resistant cap, and induction seal.
- Siro: amber PET bottle with a measuring cup and child-resistant cap.
- Ointments and gels: aluminum tubes.
- Powdered dietary supplements: 3 to 5g stick packs or gummy candy jars.
- Premium liquid collagen: 10ml glass ampule.
There are four distinguishing factors that set this packaging group apart from all other industries. These are dense mandatory information on each smallest unit, child-resistant mechanisms, seals as visible tamper-evident indicators, and traceability codes.
When to choose, when not to
This packaging group is mandatory if you operate in the industry. The more practical question is: is the design compliant with regulations, and is the structure suitable for the distribution channel?
- Acceptable when: OTC drugs in tablet form sold through retail pharmacies can be sold as individual blisters, requiring each blister to stand alone with information. Children's syrup needs a child-resistant cap and measuring cup. Dietary supplements in tablet or powder form want to enter pharmacy channels and e-commerce platforms. Multi-level marketing (MLM) dietary supplements require anti-counterfeiting labels and batch tracking codes; drugs cannot be sold through MLM.
- Not acceptable when: there is a lack of mandatory warning lines on health protection foods, as this is a minimum requirement that cannot be overlooked. Designing labels or blisters that resemble prescription drugs while the product is merely a dietary supplement can lead to penalties for misleading labeling. Changing label content or altering the announced effects without approval from the regulatory authority will incur additional time and costs for reprinting everything.
The most important design point in the pharmaceutical industry in Vietnam: the network of retail pharmacies is vast, and the habit of selling individual blisters is very common. When customers buy a single blister, they no longer have the outer box. Each blister should print the drug name, international nonproprietary name (INN), concentration or dosage, batch number, expiration date, and manufacturer name. You cannot rely on the outer box to compensate for missing information on the blister.
For health protection foods, the front must clearly state the phrase "Health protection food" along with the mandatory warning line: "This food is not a medicine and does not replace medicine." The warning text must be clearly readable, contrasting with the background; the minimum size must be verified against current regulations with legal counsel before printing. Missing this is a risk of penalties and batch recalls.
Costs, time and quantity
The cost of designing pharmaceutical packaging is moderate to high compared to other industries. The reason is the large volume of mandatory information, more internal and legal approvals. The print file must also meet strict technical standards: 3mm bleed, 5mm safety margin, small black text using K100 black, and standard print PDF (PDF/X-4). Each time the label is changed or the announced content is modified after approval, additional design and reprinting costs will arise, so it is essential to get it right from the start.
In terms of time, a complete pharmaceutical packaging set from the moment the brief is received to having a standard print file usually takes about 6 to 10 weeks, depending on the complexity of the SKU set and the number of internal legal review rounds. If the product needs to be registered for circulation, the processing time at the regulatory authority can extend for several months. It is advisable to establish a reverse schedule from the planned launch date, ensuring that design does not become the final bottleneck.
Sinh Vũ does not guarantee printing prices and does not represent the printing house. Printing prices depend on the printer, quantity, materials, and selected processing techniques, and the printing contract is between the business and the printer.
What to prepare to get started
To accurately assess the scope of work and plan the design, you should prepare:
- List of SKUs to design: product name, dosage form (tablet, syrup, powder, gel), volume or quantity per unit.
- Legal classification: OTC drugs with registration numbers, self-declared dietary supplements, or health-protecting foods that are currently or have been registered for declaration.
- Mandatory content approved by legal: ingredients, active substances, dosage, indications, warnings, registration number, or self-declaration number if available.
- Main distribution channels: retail pharmacies (whether they sell blister packs or not), pharmacy chains, e-commerce platforms, MLM.
- Request for anti-counterfeiting and traceability: is there a need for anti-counterfeit labels, QR codes, GS1 standard DataMatrix codes, or serialization for each unit?
- Expected launch timeline.
If you do not have complete legal content, the structure and graphics can still begin in parallel. However, the print file should only be finalized after the mandatory content has been approved by the company's legal department.
Decision checklist
Topic: Pharmaceutical and functional food packaging. Sinh Vũ guide, sinhvu.com
Tick each item that applies or that you can already answer, then print or save as PDF to take with you.
If you have marked most of the signs above, this is the time to discuss in more detail. Sinh Vũ can help you review and propose a direction.
This article provides general information according to the documents in effect as of October 6, 2026. This is not legal advice and does not substitute for a lawyer's opinion for your specific case. Rights and obligations between Sinh Vũ and clients arise only according to the signed contract.
References
Circular 01/2018/TT-BYT (Drug Administration); Decree 15/2018/NĐ-CP; Circular 18/2019/TT-BYT; QCVN 20-1:2024/BYT; internal industry data from Sinh Vũ; internal packaging handbook from Sinh Vũ; sevapack.com (supplementary reference).
Frequently asked questions
What needs to be printed on each blister for retail sale?
Each blister should print the drug name, international nonproprietary name (INN), concentration or dosage, batch number, expiration date, and manufacturer name. The reason is that retail pharmacies often sell blisters individually, and customers will no longer have the outer box. Missing mandatory fields poses a risk of violating drug labeling regulations (Circular 01/2018/TT-BYT); you should compare with your legal department. The principle of reasonable design is to provide enough information on each unit, without relying on the outer box.
What should the warning label on health protection food look like?
According to Decree 43/2017/NĐ-CP on product labeling (amended by Decree 111/2021/NĐ-CP), health protection food labels must include the line: "This food is not a medicine and does not replace medicine." This line needs to be easily readable, contrasting with the background, and the font size should be verified with legal regulations before finalizing the print file. Missing or overly small text is grounds for penalties and product recalls.
How are traceability codes and anti-counterfeiting labels integrated into the packaging?
The design section handles the positioning and formatting of the GS1 standard DataMatrix code, traceability QR code, and anti-counterfeiting label area in the print file. Printing and setting up the serialization system for each unit requires coordination with the printer and software provider; this is a part that the company can do itself or hire a specialized unit for the serialization chain.
This article is for reference. The scope, pricing, and specific commitments of Sinh Vũ are detailed in the proposal and signed contract.