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 an entire batch.
Pharmaceutical and functional food packaging is the group of packaging subject to the heaviest legal constraints in Vietnam, including blister packs, HDPE bottles, PET bottles, and powder packets with mandatory requirements for label information, child-resistant features, sealing, and traceability codes. It is suitable for OTC drug manufacturers, supplement companies, and health protection food that need to design packaging approved by regulatory authorities and 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
Not many brands start with a retainer right away. The most common path is: starting with a key project for both parties to validate the process and working methods, then moving to regular collaboration when trust is established and content needs are consistent.
What is pharmaceutical and functional food packaging
This is a packaging group serving two legally adjacent areas but differing in approval processes: over-the-counter (OTC) drugs are regulated by the Drug Administration under Circular 01/2018/TT-BYT and its amendments; dietary supplements, including health-protecting foods, are governed by Decree 15/2018/NĐ-CP, where health-protecting foods must be registered, 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.
Four distinctive factors that set this packaging group apart from all other sectors: dense mandatory information on each smallest unit, child-resistant mechanism, tamper-evident seals, and traceability codes.
When to choose, when not to
This packaging group is not an option but a requirement if you are in the industry. The more practical question is: is the design compliant with regulations, and is the structure suitable for the distribution channel?
- Suitable when: OTC tablets sold at retail pharmacies are packaged in tearable blisters, each blister must stand independently with information; children's syrup requires a child-resistant cap and measuring cup; dietary supplements in tablet or powder form want to enter pharmacies and e-commerce platforms; multi-level marketing (MLM) products require anti-counterfeiting labels and batch tracking codes.
- Not suitable when: lacking mandatory warning labels on health protection foods, as this is a non-negotiable minimum condition; the label or blister design resembles prescription medication while the product is just a dietary supplement, as it may be subject to penalties for misleading labeling; changing label content or claims without approval from regulatory authorities, as each change incurs additional time and costs to reprint everything.
The most important design point in the pharmaceutical industry in Vietnam: the network of independent pharmacies is very large 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 must print enough information including the drug name, international nonproprietary name (INN), concentration or dosage, batch number, expiration date, and manufacturer's name. You cannot rely on the outer box to compensate for missing information on the blister.
For health supplements, the front must clearly state the phrase "Health supplement" and the mandatory warning line: "This product is not a medicine and does not replace medication," with a minimum font height of 1.2mm and a color that contrasts with the background. Failure to comply will result in fines and product recalls, with no exceptions.
Costs, time and quantity
The cost of designing pharmaceutical packaging is moderate to high compared to other industries, due to the large amount of mandatory information, more internal and legal approvals, and the printing files must meet strict technical standards: 3mm bleed, 5mm safety margin, small black text using K100 black, and standard print PDF (PDF/X-4). Each time a label is changed or a claim is modified after approval, additional design and reprinting costs arise, so it’s best to get it right from the start.
Regarding time, a complete pharmaceutical packaging set from brief to print-ready file takes about 6 to 10 weeks depending on the complexity of the SKU set and the number of internal legal review rounds you have. If the product needs to be registered for circulation, the maximum legal timeline is 12 months from the date of receiving complete documentation (6 months for expedited review). A reverse schedule should be established from the expected launch date to avoid design becoming the final bottleneck.
Sinh Vũ does not commit to printing prices. Printing costs depend on the printer, quantity, material, and finishing techniques you choose. Sinh Vũ delivers the standard files and can recommend suitable printers, but the printing contract is between you and the printer.
What does Sinh Vũ need from you to get started
To allow Sinh Vũ to assess the scope of work and plan the design accurately, you need to provide:
- 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?
- Design budget and estimated launch timeline.
If you do not have complete legal content, Sinh Vũ can still begin the structural and graphic parts in parallel, but the print file can only be finalized after the mandatory content has been approved by your legal team. The next step is to fill out the request form so that Sinh Vũ can assess the scope and respond within one business day.
Decision checklist
Topic: Pharmaceutical and functional food packaging. Sinh Vũ guide, sinhvu.com
Select each item you find appropriate, 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.
References
Circular 01/2018/TT-BYT (Drug Administration); Decree 15/2018/NĐ-CP; Circular 18/2019/TT-BYT; QCVN 20-1:2024/BYT; pharma_health__otc.json and pharma_health__supplement.json (Sinh Vũ internal data); BAO-BI.md Branch 1 and 4; sevapack.com (supplementary reference).
Frequently asked questions
What needs to be printed on each blister for retail sale?
Each blister must print the drug name, international nonproprietary name (INN), concentration or dosage, batch number, expiration date, and manufacturer name because pharmacies often sell blister packs separately, and customers will no longer have the outer box. Missing any field is a violation of Circular 01/2018/TT-BYT. Sinh Vũ designs blisters based on the principle of providing sufficient information for each unit, without relying on the outer box.
What should the warning label on health protection food look like?
Decree 15/2018/ND-CP states: "This food is not a medicine and does not replace medicine." This line must have a contrasting color with the background and a minimum font height of 1.2mm. Missing or too small text is grounds for penalties and product recall.
Does Sinh Vũ assist in integrating traceability codes and anti-counterfeiting labels?
Sinh Vũ designs the position and format of GS1-compliant DataMatrix codes, QR codes for traceability, and anti-counterfeit labels in the print file. The printing and implementation of the serialization system require coordination with the printing house and software provider; Sinh Vũ acts as the creative director and delivers the standard files, without directly operating the serialization line.